Product profile · United States

Humira

· Patent Litigation & Settlement History ↓

Ingredientadalimumab

Application typeBLA

Application125057

Product008

Dosage formInjection

RouteSubcutaneous

Strength80MG/0.8ML

Approval date2016-10-17

Marketing statusRx

Status event—

ApplicantAbbVie Inc.

Product source

Current GenericRadar decision

Year2016

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeTRUE_DS

Anchor date2016-12-31

Patent anchor2016-12-31

Exclusivity anchor2014-12-31

Protection date—

First Final ANDA—

Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2016. Anchor type: TRUE_DS. Patent anchor: 2016-12-31. Exclusivity anchor: 2014-12-31. Anchor date: 2016-12-31. Patent tail: yes. Exclusivity tail: yes. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8911737	2022-06-05	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8974790	2022-06-05	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8992926	2022-06-05	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9546212	2022-06-05	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
6805686	2023-05-06	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8906373	2023-07-18	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9067992	2023-07-18	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9085620	2023-07-18	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9090689	2023-07-18	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8961973	2025-04-11	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8961974	2025-04-11	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8986693	2025-04-11	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9061005	2025-04-11	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9187559	2025-04-11	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9512216	2025-04-11	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8808700	2026-05-16	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
11083792	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8231876	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8883156	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8895009	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8906372	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8916153	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9096666	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9102723	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9273132	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9328165	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9913902	2027-04-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8926975	2027-06-08	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8715664	2027-07-24	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8663945	2027-09-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8906646	2027-09-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8911964	2027-09-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9090867	2027-09-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9234032	2027-09-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9284371	2027-09-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8889136	2027-10-09	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9284370	2028-06-10	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9669093	2028-06-10	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
11167030	2028-11-28	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
11191834	2028-11-28	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9085619	2028-11-28	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8420081	2030-01-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8999337	2031-02-06	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9624295	2031-03-31	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8708968	2032-01-24	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9339610	2032-01-24	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9062106	2032-04-26	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9090688	2032-04-26	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9505834	2032-04-26	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9522953	2032-04-26	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9683033	2032-04-26	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9957318	2032-04-26	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9085618	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9181337	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9181572	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9290568	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9334319	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9346879	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9359434	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9499616	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9708400	2033-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9315574	2033-04-21	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9150645	2033-05-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9266949	2033-05-13	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9499614	2034-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
9550826	2034-11-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
Orphan Exclusivity Exp. Date	—	2028-02-24		—	—	—	—	Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
761024 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2016-09-23	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2016-09-23	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2016-09-23	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2017-08-25	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2018-07-13	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2018-10-30	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2018-10-30	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-07-23	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-07-23	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 005	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761154 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2020-07-06	—	Biocon Biologics Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761154 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2020-07-06	—	Biocon Biologics Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761154 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2020-07-06	—	Biocon Biologics Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2021-12-17	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-03-18	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-03-28	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-06-17	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-08-15	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 005	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-08-15	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761255 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-12-13	—	Fresenius Kabi USA, LLC	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761255 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-12-13	—	Fresenius Kabi USA, LLC	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-02-27	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 005	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 006	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 007	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 008	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 009	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 010	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-04-06	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-05-18	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-05-23	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-05-23	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 005	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 006	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 007	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 008	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 009	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-09-29	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-09-29	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 005	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-09-29	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761118 / 005	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Pfizer Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761255 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-01-05	—	Fresenius Kabi USA, LLC	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-02-23	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 006	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 008	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 009	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 010	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 005	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-04-30	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 006	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-04-30	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-06-26	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-06-26	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-06-26	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761154 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Biocon Biologics Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761154 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Biocon Biologics Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761154 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Biocon Biologics Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 005	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-02-14	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 005	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 007	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 009	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 005	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761299 / 005	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Alvotech USA Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 006	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761024 / 008	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Amgen Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 005	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761058 / 006	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Boehringer Ingelheim Pharmaceuticals, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 005	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 007	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761071 / 005	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Sandoz Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 006	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761219 / 006	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-10-28	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 006	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761059 / 006	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2026-04-29	—	Samsung Bioepis Co., Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2026-09-25	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 004	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761216 / 004	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2026-09-25	—	Emerge Bioscience Pte. Ltd.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 57 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
761024 / 001	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2016-09-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 002	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2016-09-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 003	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2016-09-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761058 / 001	Boehringer Ingelheim Pharmaceuticals, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2017-08-25	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761058 / 002	Boehringer Ingelheim Pharmaceuticals, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2018-07-13	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 001	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2018-10-30	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 002	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2018-10-30	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761059 / 001	Samsung Bioepis Co., Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-07-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761059 / 002	Samsung Bioepis Co., Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-07-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761118 / 001	Pfizer Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761118 / 002	Pfizer Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761118 / 003	Pfizer Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761118 / 004	Pfizer Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761118 / 005	Pfizer Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2019-11-15	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761154 / 001	Biocon Biologics Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2020-07-06	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761154 / 002	Biocon Biologics Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2020-07-06	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761154 / 003	Biocon Biologics Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2020-07-06	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761216 / 001	Emerge Bioscience Pte. Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2021-12-17	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761058 / 003	Boehringer Ingelheim Pharmaceuticals, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-03-18	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 003	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-03-28	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761059 / 003	Samsung Bioepis Co., Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-06-17	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761059 / 004	Samsung Bioepis Co., Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-08-15	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761059 / 005	Samsung Bioepis Co., Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-08-15	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761255 / 001	Fresenius Kabi USA, LLC	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-12-13	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761255 / 002	Fresenius Kabi USA, LLC	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2022-12-13	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761216 / 002	Emerge Bioscience Pte. Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-02-27	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 004	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 005	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 006	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 007	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 008	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 009	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761071 / 010	Sandoz Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-03-20	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 004	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-04-06	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761058 / 004	Boehringer Ingelheim Pharmaceuticals, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-05-18	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761219 / 001	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-05-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761219 / 002	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-05-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 005	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 006	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 007	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 008	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761024 / 009	Amgen Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-08-14	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761219 / 003	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-09-29	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761219 / 004	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-09-29	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761219 / 005	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2023-09-29	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761255 / 003	Fresenius Kabi USA, LLC	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-01-05	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761299 / 001	Alvotech USA Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-02-23	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761058 / 005	Boehringer Ingelheim Pharmaceuticals, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-04-30	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761058 / 006	Boehringer Ingelheim Pharmaceuticals, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-04-30	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761299 / 002	Alvotech USA Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-06-26	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761299 / 003	Alvotech USA Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-06-26	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761299 / 004	Alvotech USA Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2024-06-26	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761299 / 005	Alvotech USA Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-02-14	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761219 / 006	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-10-28	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761059 / 006	Samsung Bioepis Co., Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2026-04-29	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761216 / 003	Emerge Bioscience Pte. Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2026-09-25	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761216 / 004	Emerge Bioscience Pte. Ltd.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2026-09-25	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (1)

Type	Date	Role	Basis	Source
BLA_PATENT_EXCLUSIVITY_REVIEW	—	BUSINESS_CLASSIFICATION_WITH_CONDITIONS	English description not available.	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.