TIVORBEX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Latest qualifying historical full-scope anchor 2017-02-24; later patent/regulatory rights remain, so DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8734847 | 2030-04-23 | DP — | N | N | DP | — | — | — |
| 8734847 | 2030-04-23 | DP — | N | N | DP 20/40 mg indomethacin unit doses require submicron particle size, lactose/SLS and specified dissolution. DP. | — | — | — |
| 8992982 | 2030-04-23 | DP — | N | N | DP | — | — | — |
| 8992982 | 2030-04-23 | DP — | N | N | DP 20/40 mg solid indomethacin dose claims require particle-size and dissolution properties. DP. | — | — | — |
| 9089471 | 2030-04-23 | U U-55 | N | N | U | — | — | — |
| 9089471 | 2030-04-23 | U U-55 | N | N | U Pain-treatment claims are tied to 20/40 mg unit doses, particle-size and dissolution properties. No evidence that all bioequivalent formulations must meet every claim limitation; retain U. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2014-02-24 | 2017-02-24 | Indomethacin 20/40 mg capsules for mild to moderate acute pain in adults; full exact-product approved scope, supported by new clinical efficacy studies. Scope version: approved uses at grant; later expansions are assessed separately. | Y | Y | 2017-02-24 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 |
|---|---|---|---|---|---|---|---|
| 204768 / 002 | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | — | Genus Lifesciences Inc. | Y | 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 1 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 204768 / 002 | Genus Lifesciences Inc. | AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED | — | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
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 (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2030-04-23 | FTO_TAIL | 20/40 mg solid indomethacin dose claims require particle-size and dissolution properties. DP. | Source |
| PATENT | 2030-04-23 | FTO_TAIL | Pain-treatment claims are tied to 20/40 mg unit doses, particle-size and dissolution properties. No evidence that all bioequivalent formulations must meet every claim limitation; retain U. | Source |
| PATENT | 2030-04-23 | FTO_TAIL | 20/40 mg indomethacin unit doses require submicron particle size, lactose/SLS and specified dissolution. DP. | Source |
| REGULATORY_EXCLUSIVITY | 2017-02-24 | CANONICAL_ANCHOR | Indomethacin 20/40 mg capsules for mild to moderate acute pain in adults; full exact-product approved scope, supported by new clinical efficacy studies. Scope version: approved uses at grant; later expansions are assessed separately. | Source |
| REGULATORY_STATUS | 2017-02-24 | DECISION_BASIS | Latest qualifying historical full-scope anchor 2017-02-24; later patent/regulatory rights remain, so DEEP_REVIEW. | 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.
No litigation or settlement record currently linked to this product.