SYMTUZA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
SYMTUZA approved 2018-07-17. US8754065 independent claim 1 is unrestricted tenofovir alafenamide hemifumarate; XRPD limitations of independent claim 4 do not narrow claim 1. The approved label specifies the matching 2:1 salt. DS-equivalent anchor 2032-08-15. US10039718 DP through 2032-10-06 and restricted switch-regimen US10786518 U through 2038-07-19 remain later rights. DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7700645 | 2026-12-26 | DS/DP — | N | N | DP | — | — | — |
| 8148374 | 2029-09-03 | DS/DP/U U-2767 | Y | N | TRUE_DS | — | — | — |
| 8148374 | 2029-09-03 | DS/DP/U U-2365 | Y | N | TRUE_DS | — | — | — |
| 8148374 | 2029-09-03 | DS/DP/U U-2353 | Y | N | TRUE_DS | — | — | — |
| 8148374 | 2029-09-03 | DS/DP/U U-2766 | Y | N | TRUE_DS | — | — | — |
| 8148374 | 2029-09-03 | DS/DP/U U-2768 | Y | N | TRUE_DS | — | — | — |
| 8148374 | 2029-09-03 | DS/DP/U U-2364 | Y | N | TRUE_DS | — | — | — |
| 8754065 | 2032-08-15 | DS/DP/U U-2765 | N | Y | DS_EQUIVALENT | — | — | — |
| 8754065 | 2032-08-15 | DS/DP/U U-2352 | N | Y | DS_EQUIVALENT | — | — | — |
| 9296769 | 2032-08-15 | DS/DP/U U-2352 | N | N | DP | — | — | — |
| 9296769 | 2032-08-15 | DS/DP/U U-2765 | N | N | DP | — | — | — |
| 10039718 | 2032-10-06 | DP — | N | N | DP | — | — | — |
| 10786518 | 2038-07-19 | U U-2978 | N | N | U | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
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 |
|---|---|---|---|---|
| PATENT | 2032-08-15 | CANONICAL_ANCHOR | SYMTUZA approved 2018-07-17. US8754065 independent claim 1 is unrestricted tenofovir alafenamide hemifumarate; XRPD limitations of independent claim 4 do not narrow claim 1. The approved label specifies the matching 2:1 salt. DS-equivalent anchor 2032-08-15. US10039718 DP through 2032-10-06 and restricted switch-regimen US10786518 U through 2038-07-19 remain later rights. DEEP_REVIEW. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2032 | DEEP_REVIEW | FINAL | 2032-08-15 | 2026-10-16 20:15:15 |
| N | 2029 | DEEP_REVIEW | FINAL | 2029-09-03 | 2026-10-15 19:53:50 |
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.