XTANDI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 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-2708 | — | — | — | — | — | — |
| 8183274 | 2026-08-24 | U U-3763 | — | — | — | — | — | — |
| 8183274 | 2026-08-24 | U U-2345 | — | — | — | — | — | — |
| 7709517 | 2027-08-13 | DS/DP — | — | — | — | — | — | — |
| 11839689 | 2033-09-11 | DP — | — | — | — | — | — | — |
| 12447128 | 2033-09-11 | U U-4313 | — | — | — | — | — | — |
| 12447128 | 2033-09-11 | U U-4312 | — | — | — | — | — | — |
| 12447128 | 2033-09-11 | U U-4314 | — | — | — | — | — | — |
| 12502357 | 2033-09-11 | U U-4365 | — | — | — | — | — | — |
| 12502357 | 2033-09-11 | U U-4363 | — | — | — | — | — | — |
| 12502357 | 2033-09-11 | U U-4364 | — | — | — | — | — | — |
| 12161628 | 2037-02-23 | U U-4102 | — | — | — | — | — | — |
| 12161628 | 2037-02-23 | U U-4101 | — | — | — | — | — | — |
| 12161628 | 2037-02-23 | U U-4103 | — | — | — | — | — | — |
| 12161628 | 2037-02-23 | U U-4104 | — | — | — | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 217322 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ZYDUS PHARMS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216068 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2026-04-20 | — | SANDOZ 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 1 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 |
|---|---|---|---|---|---|---|
| 216068 / 002 | SANDOZ INC | FINAL_APPROVAL · FINAL_APPROVED | 2026-04-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC | 2026-04-20 | TERMINAL_GENERIC_BASIS | Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted. | Source |
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 Other product (master ID 1346); not evidence for this strength
|
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 Other product (master ID 1346); not evidence for this strength
|
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. | |||||