BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_TAIL: The oral lenacapavir component retains the same later sodium-crystal FTO tail. Injectable-only and BIC/TAF/FTC claims are excluded.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9216996 | 2033-12-19 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | Y | N | TRUE_DS Bictegravir component compound end precedes the selected lenacapavir anchor. | — | — | — |
| 9216996 | 2033-12-19 | DS;DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 9732092 | 2033-12-19 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | Y | N | TRUE_DS Bictegravir component compound end precedes the selected lenacapavir anchor. | — | — | — |
| 9732092 | 2033-12-19 | DS;DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 9951043 | 2034-02-28 | DS;DP;U U-4602 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 10385067 | 2035-06-19 | U U-4602 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 9708342 | 2035-06-19 | DS;DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 10071985 | 2037-08-17 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | Y | N | TRUE_DS Lenacapavir compound anchor applies to both the BIC/LEN and lenacapavir oral components of the starter pack. The FDA reference compound end is 2037-08-17; same-moiety NCE ends 2027-12-22. Three-component BIKTARVY and injectable-only claims are not substituted for the target. | — | — | — |
| 10071985 | 2037-08-17 | DS;DP — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 10654827 | 2037-08-17 | U U-4602 | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
| 11267799 | 2038-08-16 | CLAIM_REVIEW_NOT_EXACT_OB_LISTING — | N | N | OTHER_CRYSTAL The oral lenacapavir component retains the same later sodium-crystal FTO tail. Injectable-only and BIC/TAF/FTC claims are excluded. | — | — | — |
| 11267799 | 2038-08-16 | DS — | — | — | — OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | — | 2027-12-22 | — | — | — | — | Source | |
| NP | — | 2029-08-27 | — | — | — | — | Source |
2026-10-13 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · Historical coverage: ANNUALS_AND_MONTHLY_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 |
|---|---|---|---|---|---|---|---|
| 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 (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2033-12-19 | HISTORICAL_CONTEXT | Bictegravir component compound end precedes the selected lenacapavir anchor. | Source |
| PATENT | 2033-12-19 | HISTORICAL_CONTEXT | Bictegravir component compound end precedes the selected lenacapavir anchor. | Source |
| PATENT | 2037-08-17 | CANONICAL_ANCHOR | Lenacapavir compound anchor applies to both the BIC/LEN and lenacapavir oral components of the starter pack. The FDA reference compound end is 2037-08-17; same-moiety NCE ends 2027-12-22. Three-component BIKTARVY and injectable-only claims are not substituted for the target. | Source |
| PATENT | 2038-08-16 | FTO_TAIL | The oral lenacapavir component retains the same later sodium-crystal FTO tail. Injectable-only and BIC/TAF/FTC claims are excluded. | Source |
| REGULATORY_STATUS | 2037-08-17 | CANONICAL_DECISION | POST_ANCHOR_TAIL: The oral lenacapavir component retains the same later sodium-crystal FTO tail. Injectable-only and BIC/TAF/FTC claims are excluded. | 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.