Product profile · United States

INLYTA

· Patent Litigation & Settlement History ↓

IngredientAXITINIB

Application typeNDA

Application202324

Product002

Dosage formTABLET

RouteORAL

Strength5MG

Approval date2012-01-27

Marketing statusPrescription

Status event—

ApplicantPF PRISM CV

Product source

Current GenericRadar decision

Year2025

SelectionEXISTING_GENERIC

ReviewDISQUALIFIED

Anchor typeFINAL_ANDA

Anchor date2025-10-30

Patent anchor—

Exclusivity anchor—

Protection date2037-07-12

First Final ANDA2025-10-30

Status event—

FDA first-generic table and 211650 product/TE listings identify INLYTA 5 mg. Do not use the linked earlier 2019 tentative-approval date.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8791140	2030-12-14	DS —	N	N	CRYSTALLINE_FORM	—	—	—
8791140	2030-12-14	DS —	N	N	CRYSTALLINE_FORM Axitinib specific crystal-form/XRD limitations. Distinguish official DS flags from TRUE_DS.	—	—	—
8791140	2031-06-14	— —	N	N	CRYSTALLINE_FORM	—	2031-06-14	—
8791140	2031-06-14	PED —	N	N	CRYSTALLINE_FORM PED row inherits the underlying patent classification; do not add another six months to this date. Axitinib specific crystal-form/XRD limitations; distinguish official DS flags from TRUE_DS.	—	—	—
10570202	2035-02-03	U U-2844	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE	—	—	—
10570202	2035-02-03	U U-2844	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE Pembrolizumab plus axitinib combination; excludes axitinib monotherapy.	—	—	—
12534530	2035-02-03	U U-4412	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE	—	—	—
12534530	2035-02-03	U U-4411	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE	—	—	—
12534530	2035-02-03	U U-4411	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE Untreated RCC with pembrolizumab plus axitinib at specified doses; excludes monotherapy.	—	—	—
12534530	2035-02-03	U U-4412	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE Untreated RCC with pembrolizumab plus axitinib at specified doses; excludes monotherapy.	—	—	—
10570202	2035-08-03	— —	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE	—	2035-08-03	—
10570202	2035-08-03	PED —	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE Pembrolizumab plus axitinib combination; excludes axitinib monotherapy.	—	—	—
12534530	2035-08-03	— —	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE	—	2035-08-03	—
12534530	2035-08-03	PED —	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE Untreated RCC with pembrolizumab plus axitinib at specified doses; excludes monotherapy.	—	—	—
10869924	2037-01-12	U U-3044	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE	—	—	—
10869924	2037-01-12	U U-3044	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE Avelumab plus axitinib RCC combination; excludes monotherapy.	—	—	—
10869924	2037-07-12	— —	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE	—	2037-07-12	—
10869924	2037-07-12	PED —	N	N	POPULATION_OR_INDICATION_RESTRICTED_USE Avelumab plus axitinib RCC combination; excludes monotherapy.	—	—	—

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 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE

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

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
210234 / 002	APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED	—	—	TEVA PHARMS	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211650 / 002	FINAL_APPROVAL · FINAL_APPROVED	2025-10-30	—	APOTEX INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source
211650 / 002	FINAL_APPROVAL · FINAL_APPROVED	2025-10-30	—	APOTEX INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source
211650 / 002	FINAL_APPROVAL · FINAL_APPROVAL	2025-10-30	—	APOTEX INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source
211650 / 002	FINAL_APPROVAL · FINAL_APPROVAL	2025-10-30	—	APOTEX INC	N	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	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
211650 / 002	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVED	2025-10-30	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—
211650 / 002	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVED	2025-10-30	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—
211650 / 002	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVAL	2025-10-30	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—
211650 / 002	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVAL	2025-10-30	EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED	Source	—

Decision evidence (10)

Type	Date	Role	Basis	Source
GENERIC_APPROVAL	2025-10-30	DISQUALIFYING_FINAL_GENERIC	Exact Final ANDA211650/002 -> NDA202324/002	Source
PATENT	2030-12-14	FTO_TAIL	Axitinib specific crystal-form/XRD limitations. Distinguish official DS flags from TRUE_DS.	Source
PATENT	2031-06-14	FTO_TAIL	PED row inherits the underlying patent classification; do not add another six months to this date. Axitinib specific crystal-form/XRD limitations; distinguish official DS flags from TRUE_DS.	Source
PATENT	2035-02-03	FTO_TAIL	Pembrolizumab plus axitinib combination; excludes axitinib monotherapy.	Source
PATENT	2035-02-03	FTO_TAIL	Untreated RCC with pembrolizumab plus axitinib at specified doses; excludes monotherapy.	Source
PATENT	2035-02-03	FTO_TAIL	Untreated RCC with pembrolizumab plus axitinib at specified doses; excludes monotherapy.	Source
PATENT	2035-08-03	FTO_TAIL	Pembrolizumab plus axitinib combination; excludes axitinib monotherapy.	Source
PATENT	2035-08-03	FTO_TAIL	Untreated RCC with pembrolizumab plus axitinib at specified doses; excludes monotherapy.	Source
PATENT	2037-01-12	FTO_TAIL	Avelumab plus axitinib RCC combination; excludes monotherapy.	Source
PATENT	2037-07-12	FTO_TAIL	Avelumab plus axitinib RCC combination; excludes monotherapy.	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.