ORGOVYX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
ORGOVYX 120mg approved 2020-12-18. US12336990 independent claim 1 covers the approved advanced-prostate-cancer regimen: 360mg loading then about one day later 120mg daily, without mandatory duration or PK outcome. Full approved indication coverage supports DS-equivalent anchor 2037-09-29. No later verified matched right established. Non-OB specific solvate/crystal/process correspondence remains unestablished; no unsupported product link or extension date is inserted. CANDIDATE.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8058280 | 2026-01-28 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8058280 | 2026-01-28 | DS/DP — | Y | Y | TRUE_DS Claim 1 thiophene-pyrimidinedione genus permits dimethylamino, substituted nitrogen heteroaryl and methoxyurea substituents of relugolix. Genus structure visually checked; species claims also include other analogs, not a formulation limitation. | — | — | — |
| 7300935 | 2029-01-28 | DS — | Y | Y | TRUE_DS | — | — | — |
| 7300935 | 2029-01-28 | DS — | Y | Y | TRUE_DS Independent claim 2 explicitly claims relugolix or a salt without crystal, formulation or indication limitation. USPTO PTE certificate included; use the already-extended Orange Book expiry without adding another five years. | — | — | — |
| 11795178 | 2033-09-27 | DS/DP — | N | N | IMPURITY_MIXTURE | — | — | — |
| 11795178 | 2033-09-27 | DS/DP — | N | N | IMPURITY_MIXTURE Relugolix mixture requires a second structurally identified related compound; not unrestricted molecule protection. | — | — | — |
| 12325714 | 2033-09-27 | DS/DP — | N | N | IMPURITY_MIXTURE | — | — | — |
| 12325714 | 2033-09-27 | DS/DP — | N | N | IMPURITY_MIXTURE Relugolix solid mixtures requiring specified structurally identified related compounds; no unrestricted drug-substance claim. | — | — | — |
| 10350170 | 2036-02-25 | DP — | N | N | FORMULATION | — | — | — |
| 10350170 | 2036-02-25 | DP — | N | N | FORMULATION Relugolix 40 mg tablet with D-mannitol/excipient restrictions, rather than unrestricted compound protection. | — | — | — |
| 10449191 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE | — | — | — |
| 10449191 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE Relugolix prostate cancer course requires treatment suspension for testosterone recovery; not universal continuous approved therapy. | — | — | — |
| 10786501 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE | — | — | — |
| 10786501 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE Relugolix hormone-dependent prostate cancer regimen requires 24-week FSH and pharmacokinetic outcomes; not established for every approved patient/course. | — | — | — |
| 11583526 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE | — | — | — |
| 11583526 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE Relugolix standard loading/maintenance regimen with individual loading-AUC versus steady-state-AUC requirement; universal outcome not demonstrated by the label. | — | — | — |
| 12097198 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE | — | — | — |
| 12097198 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE Relugolix prostate regimen additionally requires individual testosterone below 50 ng/dL by day 8; this outcome is not universal in the label. | — | — | — |
| 12144809 | 2037-09-29 | U U-4035 | N | N | LIMITED_USE | — | — | — |
| 12144809 | 2037-09-29 | U U-4035 | N | N | LIMITED_USE Relugolix prostate regimen requires concurrent P-gp inhibitor separated by six hours; excludes patients without that co-therapy. | — | — | — |
| 12336990 | 2037-09-29 | U U-3020 | N | Y | DS_EQUIVALENT | — | — | — |
| 12336990 | 2037-09-29 | U U-3020 | N | Y | DS_EQUIVALENT Claim 1 fixes 360 mg loading and a 120 mg once-daily dose; the FDA label also permits 240 mg once daily with unavoidable combined P-gp/strong CYP3A inducer co-administration. All independent claims were rechecked: no unrestricted 240 mg pathway is established. Covers the standard-dose advanced-prostate indication, but not the entire approved product/dose scope. TrueDS=N, DS-equivalent=N. | — | — | — |
| 12629370 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE | — | — | — |
| 12629370 | 2037-09-29 | U U-3020 | N | N | LIMITED_USE Relugolix treatment for at least 24 weeks with cardiovascular-event reduction/risk condition; not all approved patients or courses. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2020-12-18 | 2025-12-18 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2025-12-18 | Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · 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 |
|---|---|---|---|---|---|---|---|
| 219913 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | 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 0 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 |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2037-09-29 | CANONICAL_ANCHOR | ORGOVYX 120mg approved 2020-12-18. US12336990 independent claim 1 covers the approved advanced-prostate-cancer regimen: 360mg loading then about one day later 120mg daily, without mandatory duration or PK outcome. Full approved indication coverage supports DS-equivalent anchor 2037-09-29. No later verified matched right established. Non-OB specific solvate/crystal/process correspondence remains unestablished; no unsupported product link or extension date is inserted. CANDIDATE. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2037 | CANDIDATE | FINAL | 2037-09-29 | 2026-10-16 20:15:15 |
| N | 2029 | DEEP_REVIEW | FINAL | 2029-01-28 | 2026-10-11 18:11:30 |
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.