Product profile · United States

Xolair

· Patent Litigation & Settlement History ↓

Ingredientomalizumab

Application typeBLA

Application103976

Product005

Dosage formInjection

RouteSubcutaneous

Strength75MG/0.5ML

Approval date2023-08-17

Marketing statusRx

Status event—

ApplicantGenentech, Inc.

Product source

Current GenericRadar decision

Year2015

SelectionDEEP_REVIEW

ReviewFINAL_CHECKING

Anchor typeREGULATORY_EXCLUSIVITY

Anchor date2015-06-20

Patent anchor—

Exclusivity anchor2015-06-20

Protection date—

First Final ANDA—

Status event—

{"sequence":264,"product_key":"US:BLA:103976:005","judgment_status":"PROVISIONAL_EVIDENCE_SCREEN","review_basis":"LATER_RIGHT_SIGNAL","reason_codes":["LATER_PATENT_REFERENCE_DATE: US10034940, US10676710, US10829732, US11078294, US6267958, US8574869, US11987637, US12030959, US10017732"],"unknown_patent_terms":[],"pending_publications":[],"regulatory_anchor":"2015-06-20","later_regulatory_events":[],"batch":"BLA-05-06","review_version":"1.1","selection_status":"DEEP_REVIEW","verified":false,"anchor_status":"OPERATIONAL_UNVERIFIED","rights_anchor_date":"2015-06-20","patent_anchor_numbers":[],"patent_term_verified":false,"canonical_judgment_confirmed":false,"first_biosimilar_approval_date":null,"first_final_generic_date":null,"has_existing_generic":null,"has_existing_biosimilar":null,"report":"BLA_05_06_50_JUDGMENT_20261021.html","report_sha256":"d3f5cba95e750a9f93f53184cc6d1c82c363bb5bb718ddbc60ccfe5c14efed29","regulatory_update_pending":true,"local_patent_review_pending":true,"FDA_followup":[{"issue":"FDA_RPE_DETERMINATION_AND_END_DATE_NOT_LOCATED","status":"UPDATE_PENDING","reason":"FDA PB target fields remain blank; no additional exact-target final determination located in the retrieved public FDA letters/review/administrative documents. Orange Book has no target BLA rows. Operational baseline retained with verified=false."}],"tail_patents":["US10034940","US10676710","US10829732","US11078294","US6267958","US8574869","US11987637","US12030959","US10017732"]}

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
US6267958	2017-06-20	— —	N	N	DP_NON_DS {"classification":"DP_NON_DS","claim_count":47,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
10034940	2025-11-04	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
US10034940	2025-11-04	— —	N	N	DP_NON_DS {"classification":"DP_NON_DS","claim_count":24,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
11078294	2028-07-08	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
11987637	2028-07-08	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
8574869	2028-07-08	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
US11078294	2028-07-08	— —	N	N	PROCESS_NON_DS {"classification":"PROCESS_NON_DS","claim_count":8,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
US11987637	2028-07-08	— —	N	N	PROCESS_NON_DS {"classification":"PROCESS_NON_DS","claim_count":30,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
US8574869	2028-07-08	— —	N	N	PROCESS_NON_DS {"classification":"PROCESS_NON_DS","claim_count":10,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
10017732	2034-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
10676710	2034-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
10829732	2034-03-14	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
US10017732	2034-03-14	— —	N	N	PROCESS_NON_DS {"classification":"PROCESS_NON_DS","claim_count":24,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
US10676710	2034-03-14	— —	N	N	PROCESS_NON_DS {"classification":"PROCESS_NON_DS","claim_count":32,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
US10829732	2034-03-14	— —	N	N	PROCESS_NON_DS {"classification":"PROCESS_NON_DS","claim_count":22,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—
12030959	2043-07-20	PURPLE_BOOK —	—	—	— Original PB source record retained in gnr_patent_source_records. No TRUE_DS/DS-equivalent judgment.	—	—	—
US12030959	2043-07-20	— —	N	N	U_PARTIAL_INDICATION_NON_DS_EQ {"classification":"U_PARTIAL_INDICATION_NON_DS_EQ","claim_count":29,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"}	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
RPE_BASELINE	2003-06-20	2015-06-20	Full-product 12-year operational assumption; not FDA determination	Y	Y	—	—	Source

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
761399 / 001	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761399 / 001	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-03-07	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761399 / 002	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761399 / 002	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-03-07	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761399 / 003	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-12-01	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761399 / 003	INTERCHANGEABILITY · INTERCHANGEABLE	—	—	CELLTRION, Inc.	N	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source
761399 / 003	FINAL_APPROVAL · BIOSIMILAR_APPROVED	2025-12-01	—	CELLTRION, 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 4 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
761399 / 001	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-03-07	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761399 / 002	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-03-07	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761399 / 003	CELLTRION, Inc.	BIOSIMILAR_APPROVAL · BIOSIMILAR_APPROVED	2025-12-01	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
761399 / 003	CELLTRION, Inc.	FINAL_APPROVAL · BIOSIMILAR_APPROVED	2025-12-01	REFERENCE_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (10)

Type	Date	Role	Basis	Source
PATENT	2017-06-20	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2025-11-04	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2028-07-08	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2028-07-08	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2028-07-08	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2034-03-14	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2034-03-14	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2034-03-14	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2043-07-20	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
REGULATORY_EXCLUSIVITY	2015-06-20	ANCHOR_CALCULATION	User-adopted operational baseline; inherited dates do not restart RPE; not FDA determination	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.