Product profile · United States
STRIBILD
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_TAIL; Canonical 2030-10-30; latest tail 2033-04-06
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7176220 | 2026-08-27 | DS/DP/U U-257 | — | — | — | — | — | — |
| 7635704 | 2026-10-26 | DS/DP/U U-257 | — | — | — | — | — | — |
| 8981103 | 2026-10-26 | DS/DP — | — | — | — | — | — | — |
| 7176220 | 2027-02-27 | — — | — | — | — | — | 2027-02-27 | — |
| 7176220 | 2027-02-27 | ORANGE_BOOK U-257 | Y | N | TRUE_DS English description not available. | — | 2027-02-27 | — |
| 7635704 | 2027-04-26 | — — | — | — | — | — | 2027-04-26 | — |
| 7635704 | 2027-04-26 | ORANGE_BOOK U-257 | N | N | DP English description not available. | — | 2027-04-26 | — |
| 8981103 | 2027-04-26 | — — | — | — | — | — | 2027-04-26 | — |
| 8981103 | 2027-04-26 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2027-04-26 | — |
| 8148374 | 2029-09-03 | DS/DP/U U-1279 | — | — | — | — | — | — |
| 9891239 | 2029-09-03 | DP/U U-257 | — | — | — | — | — | — |
| 8148374 | 2030-03-03 | — — | — | — | — | — | 2030-03-03 | — |
| 8148374 | 2030-03-03 | ORANGE_BOOK U-1279 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2030-03-03 | — |
| 9891239 | 2030-03-03 | — — | — | — | — | — | 2030-03-03 | — |
| 9891239 | 2030-03-03 | ORANGE_BOOK U-257 | N | Y | DS_EQUIVALENT English description not available. | — | 2030-03-03 | — |
| 8633219 | 2030-04-30 | DP/U U-257 | — | — | — | — | — | — |
| 8633219 | 2030-10-30 | — — | — | — | — | — | 2030-10-30 | — |
| 8633219 | 2030-10-30 | ORANGE_BOOK U-257 | N | Y | DS_EQUIVALENT English description not available. | — | 2030-10-30 | — |
| 10039718 | 2032-10-06 | DP — | — | — | — | — | — | — |
| 10039718 | 2033-04-06 | — — | — | — | — | — | 2033-04-06 | — |
| 10039718 | 2033-04-06 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2033-04-06 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2012-08-27 | 2015-08-27 | English description not available. | N | N | — | Source | |
| NCE | 2012-08-27 | 2017-08-27 | NEW CHEMICAL ENTITY | Y | Y | 2017-08-27 | Source | |
| I-704 | 2014-12-17 | 2017-12-17 | EXPANDED INDICATION TO INCLUDE PATIENTS WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA <50 COPIES/ML) ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TREATMENT FAILURE IN ORDER TO REPLACE THEIR CURRENT REGIMEN | N | N | — | Source | |
| NPP | 2017-01-27 | 2020-01-27 | English description not available. | N | N | — | 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 (12)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-02-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-26 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2027-04-26 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2030-03-03 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2030-03-03 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2030-10-30 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2033-04-06 | FTO_TAIL | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | EXPANDED INDICATION TO INCLUDE PATIENTS WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA <50 COPIES/ML) ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TREATMENT FAILURE IN ORDER TO REPLACE THEIR CURRENT REGIMEN | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | NEW CHEMICAL ENTITY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2030-10-30 | CANONICAL_DECISION | POST_ANCHOR_TAIL; Canonical 2030-10-30; latest tail 2033-04-06 | 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.
No litigation or settlement record currently linked to this product.