Product profile · United States

XTANDI

· Patent Litigation & Settlement History ↓

IngredientENZALUTAMIDE

Application typeNDA

Application203415

Product001

Dosage formCAPSULE

RouteORAL

Strength40MG

Approval date2012-08-31

Marketing statusPrescription

Status event—

ApplicantASTELLAS

Product source

Current GenericRadar decision

Year2021

SelectionEXISTING_GENERIC

ReviewCOMPLETED

Anchor type—

Anchor date—

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA2021-05-14

Status event—

Final ANDA candidate 209614/001 on 2021-05-14. Source-level RLD/TE screen; earliest Final and exact Product source reference require independent review.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
9126941	2026-05-15	U U-1588	—	—	—	—	—	—
9126941	2026-05-15	U U-3763	—	—	—	—	—	—
9126941	2026-05-15	U U-2708	—	—	—	—	—	—
9126941	2026-05-15	U U-2345	—	—	—	—	—	—
8183274	2026-08-24	U U-3763	—	—	—	—	—	—
8183274	2026-08-24	U U-2708	—	—	—	—	—	—
8183274	2026-08-24	U U-1588	—	—	—	—	—	—
8183274	2026-08-24	U U-1281	—	—	—	—	—	—
8183274	2026-08-24	U U-2345	—	—	—	—	—	—
7709517	2027-08-13	DS/DP —	—	—	—	—	—	—
12161628	2037-02-23	U U-4104	—	—	—	—	—	—
12161628	2037-02-23	U U-4101	—	—	—	—	—	—
12161628	2037-02-23	U U-4102	—	—	—	—	—	—
12161628	2037-02-23	U U-4103	—	—	—	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
I-926	—	2026-11-17		—	—	—	—	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
209614 / 001	FINAL_APPROVAL · FINAL_APPROVED	2021-05-14	—	ACTAVIS LABORATORIES FL INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
209645 / 001	FINAL_APPROVAL · FINAL_APPROVED	2022-04-22	—	APOTEX INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
209667 / 001	FINAL_APPROVAL · FINAL_APPROVED	2024-09-26	—	ZYDUS PHARMACEUTICALS USA INC	N	EXACT_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 3 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
209614 / 001	ACTAVIS LABORATORIES FL INC	FINAL_APPROVAL · FINAL_APPROVED	2021-05-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
209645 / 001	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVED	2022-04-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
209667 / 001	ZYDUS PHARMACEUTICALS USA INC	FINAL_APPROVAL · FINAL_APPROVED	2024-09-26	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	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.

Event date	Party	Event	Licensed entry	Evidence	Source
2026-08-18	Teva Pharmaceuticals USA, Inc. v. Kennedy (CMS / HHS)	LITIGATION	2027-08 (Teva forecast)	SOURCE_CONFIRMED	Source
D.C. Circuit, No. 25-5425, decided 2026-08-18. Court addressed Teva challenge to CMS bona fide generic marketing rule under Medicare Drug Price Negotiation Program; reversed/remanded on ripeness, did not decide merits. Opinion records Teva declarant expected generic XTANDI 40mg capsule to launch shortly before 2027-08-13. This is a litigation-reported company forecast, NOT a court-ordered generic entry date, patent settlement term, FDA approval date, or confirmed launch. FDA first Final ANDA 209614 (Actavis Laboratories FL Inc) approved 2021-05-14 is separate.
2018-06-18	Teva Pharmaceuticals USA / Actavis vs. Medivation, Astellas and patent holders	SETTLEMENT	Not disclosed	SOURCE_CONFIRMED	Source
Teva federal complaint filed 2025-01-15, paragraphs 100-101: Teva filed Paragraph IV ANDA for XTANDI enzalutamide capsules on 2016-08-31, patent infringement suit followed and was dismissed pursuant to settlement on 2018-06-18. Teva states a plan to launch its generic capsule before expiration of US7709517 (2027-08-13). Settlement agreement does not disclose an exact licensed entry date here. No actual launch is established. Distinct from 2026-08-18 Teva v CMS appeal; no changes to FDA Final ANDA approval or GNR selection.