Product profile · United States
Stelara
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2023. Anchor type: PATENT. Patent anchor: 2023-09-25. Exclusivity anchor: 2021-09-25. Anchor date: 2023-09-25. Patent tail: not established. Exclusivity tail: not established. 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 |
|---|---|---|---|---|---|---|---|---|
| 6902734 | 2023-09-25 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 8852889 | 2032-07-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9475858 | 2032-07-06 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9217168 | 2033-03-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 9663810 | 2033-03-14 | PURPLE_BOOK — | — | — | — Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment. | — | — | — |
| 10961307 | 2039-09-24 | 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 |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-10 · PENDING_EXCLUSIVITY_CONFIRMATION · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 761285 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761285 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761285 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761285 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761285 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761285 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761331 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761331 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-04-16 | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-04-16 | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761425 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-27 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-27 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-27 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761364 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-10 | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761364 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-10 | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761364 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-10 | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-18 | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 004 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-17 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-17 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-17 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-20 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761285 / 004 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-26 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761285 / 005 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-26 | — | Amgen Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 004 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-02-12 | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 004 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-21 | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 004 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761343 / 004 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Alvotech USA Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 004 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 005 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761379 / 004 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Fresenius Kabi USA, LLC | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 004 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761425 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 001 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 002 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 003 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 004 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761419 / 004 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | — | Bio-Thera Solutions, Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761338 / 004 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-06-12 | — | CELLTRION, Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 004 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-06-27 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761373 / 005 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-06-27 | — | Samsung Bioepis Co., Ltd. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761364 / 001 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761364 / 002 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761364 / 003 | INTERCHANGEABILITY · INTERCHANGEABLE | — | — | Accord BioPharma Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 005 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-08-14 | — | Biocon Biologics Inc. | N | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 761406 / 006 | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-08-14 | — | Biocon Biologics Inc. | 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 37 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 |
|---|---|---|---|---|---|---|
| 761285 / 001 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761285 / 002 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761285 / 003 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761331 / 001 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2023-10-31 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761343 / 001 | Alvotech USA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-04-16 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761343 / 002 | Alvotech USA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-04-16 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761373 / 001 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761373 / 002 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761425 / 001 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-06-28 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761379 / 001 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-27 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761379 / 002 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-27 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761379 / 003 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-09-27 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761364 / 001 | Accord BioPharma Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-10 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761364 / 002 | Accord BioPharma Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-10 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761364 / 003 | Accord BioPharma Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-10 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761343 / 003 | Alvotech USA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-10-18 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761406 / 001 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761406 / 002 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761406 / 003 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761406 / 004 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-11-29 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761338 / 001 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-17 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761338 / 002 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-17 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761338 / 003 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-17 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761373 / 003 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-20 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761285 / 004 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-26 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761285 / 005 | Amgen Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2024-12-26 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761343 / 004 | Alvotech USA Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-02-12 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761379 / 004 | Fresenius Kabi USA, LLC | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-03-21 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761419 / 001 | Bio-Thera Solutions, Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761419 / 002 | Bio-Thera Solutions, Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761419 / 003 | Bio-Thera Solutions, Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761419 / 004 | Bio-Thera Solutions, Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-05-22 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761338 / 004 | CELLTRION, Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-06-12 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761373 / 004 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-06-27 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761373 / 005 | Samsung Bioepis Co., Ltd. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2025-06-27 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761406 / 005 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-08-14 | REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 761406 / 006 | Biocon Biologics Inc. | BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED | 2026-08-14 | 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.