Product profile · United States
VOSEVI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US9296782 c1/2 voxilaprevir plus product PED. Later polymer solid-dispersion combination retained.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8334270 | 2028-03-21 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8334270 | 2028-03-21 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8580765 | 2028-03-21 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8580765 | 2028-03-21 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8735372 | 2028-03-21 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8735372 | 2028-03-21 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8957046 | 2028-03-21 | U U-2040 | — | — | — | — | — | — |
| 8957046 | 2028-03-21 | U U-2039 | — | — | — | — | — | — |
| 8957046 | 2028-03-21 | ORANGE_BOOK U-2039,U-2040 | N | Y | DS_EQUIVALENT English description not available. | — | — | — |
| 9085573 | 2028-03-21 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 9085573 | 2028-03-21 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8334270 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 8334270 | 2028-09-21 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-09-21 | — |
| 8580765 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 8580765 | 2028-09-21 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-09-21 | — |
| 8735372 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 8735372 | 2028-09-21 | ORANGE_BOOK U-2039,U-2040 | N | Y | DS_EQUIVALENT English description not available. | — | 2028-09-21 | — |
| 9085573 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 9085573 | 2028-09-21 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-09-21 | — |
| 7964580 | 2029-03-26 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 7964580 | 2029-03-26 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8633309 | 2029-03-26 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8633309 | 2029-03-26 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8889159 | 2029-03-26 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8889159 | 2029-03-26 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 7964580 | 2029-09-26 | — — | — | — | — | — | 2029-09-26 | — |
| 7964580 | 2029-09-26 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2029-09-26 | — |
| 8633309 | 2029-09-26 | — — | — | — | — | — | 2029-09-26 | — |
| 8633309 | 2029-09-26 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2029-09-26 | — |
| 8889159 | 2029-09-26 | — — | — | — | — | — | 2029-09-26 | — |
| 8889159 | 2029-09-26 | ORANGE_BOOK U-2039,U-2040 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2029-09-26 | — |
| 9284342 | 2030-09-13 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 9284342 | 2030-09-13 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8618076 | 2030-12-11 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8618076 | 2030-12-11 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 9284342 | 2031-03-13 | — — | — | — | — | — | 2031-03-13 | — |
| 9284342 | 2031-03-13 | ORANGE_BOOK U-2039,U-2040 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2031-03-13 | — |
| 8618076 | 2031-06-11 | — — | — | — | — | — | 2031-06-11 | — |
| 8618076 | 2031-06-11 | ORANGE_BOOK U-2039,U-2040 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2031-06-11 | — |
| 8575135 | 2032-11-16 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8575135 | 2032-11-16 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8921341 | 2032-11-16 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8921341 | 2032-11-16 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 8940718 | 2032-11-16 | DS/DP/U U-2040 | — | — | — | — | — | — |
| 8940718 | 2032-11-16 | DS/DP/U U-2039 | — | — | — | — | — | — |
| 9868745 | 2032-11-16 | DS/DP — | — | — | — | — | — | — |
| 9868745 | 2032-11-16 | ORANGE_BOOK — | N | Y | DS_EQUIVALENT English description not available. | — | — | — |
| 8575135 | 2033-05-16 | — — | — | — | — | — | 2033-05-16 | — |
| 8575135 | 2033-05-16 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS English description not available. | — | 2033-05-16 | — |
| 8921341 | 2033-05-16 | — — | — | — | — | — | 2033-05-16 | — |
| 8921341 | 2033-05-16 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS English description not available. | — | 2033-05-16 | — |
| 8940718 | 2033-05-16 | — — | — | — | — | — | 2033-05-16 | — |
| 8940718 | 2033-05-16 | ORANGE_BOOK U-2039,U-2040 | Y | N | TRUE_DS English description not available. | — | 2033-05-16 | — |
| 11116783 | 2034-01-30 | DP/U U-2039 | — | — | — | — | — | — |
| 11116783 | 2034-01-30 | DP/U U-2040 | — | — | — | — | — | — |
| 9296782 | 2034-07-17 | DS/DP — | — | — | — | — | — | — |
| 9296782 | 2034-07-17 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 11116783 | 2034-07-30 | — — | — | — | — | — | 2034-07-30 | — |
| 11116783 | 2034-07-30 | ORANGE_BOOK U-2039,U-2040 | N | N | DP English description not available. | — | 2034-07-30 | — |
| 10912814 | 2037-06-01 | DP — | — | — | — | — | — | — |
| 10912814 | 2037-06-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 11338007 | 2037-06-01 | DP/U U-2040 | — | — | — | — | — | — |
| 11338007 | 2037-06-01 | DP/U U-2039 | — | — | — | — | — | — |
| 11338007 | 2037-12-01 | — — | — | — | — | — | 2037-12-01 | — |
| 11338007 | 2037-12-01 | ORANGE_BOOK U-2039,U-2040 | N | N | DP English description not available. | — | 2037-12-01 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2017-07-18 | 2022-07-18 | NEW CHEMICAL ENTITY | Y | Y | 2022-07-18 | Source |
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 |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 |
|---|---|---|---|---|
| ANNUAL_DECISION_RECHECK | — | ANCHOR_AND_TAIL | US9296782 c1/2 voxilaprevir plus product PED. Later polymer solid-dispersion combination retained. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-07-17 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-07-17 | 2026-10-13 23:50:30 |
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.