TIVICAY
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8129385 | 2027-10-05 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8129385 | 2027-10-05 | DS/DP — | Y | Y | TRUE_DS Independent claims 6-9 explicitly claim dolutegravir and its sodium salt without indication or formulation limitations; correction certificate reviewed. | — | — | — |
| 8129385 | 2028-04-05 | — — | Y | Y | TRUE_DS | — | 2028-04-05 | — |
| 8129385 | 2028-04-05 | PED — | Y | Y | TRUE_DS Independent claims 6-9 explicitly claim dolutegravir and its sodium salt without indication or formulation limitations; correction certificate reviewed. | — | — | — |
| 9242986 | 2029-12-08 | DS/DP — | N | N | CRYSTAL | — | — | — |
| 9242986 | 2029-12-08 | DS/DP — | N | N | CRYSTAL Dolutegravir sodium crystal/hydrate defined by diffraction, IR or NMR; corrected structures retained. | — | — | — |
| 9242986 | 2030-06-08 | — — | N | N | CRYSTAL | — | 2030-06-08 | — |
| 9242986 | 2030-06-08 | PED — | N | N | CRYSTAL Dolutegravir sodium crystal/hydrate defined by diffraction, IR or NMR; corrected structures retained. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-166 | 2015-07-30 | 2018-07-30 | UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY (ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT SUBJECTS | N | N | — | M-166 + I-758
Full coverage date: —
| Source |
| NCE | 2013-08-12 | 2018-08-12 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2018-08-12 | M-166 + I-758
Full coverage date: 2018-08-12
| Source |
| I-758 | 2017-11-21 | 2020-11-21 | FOR USE WITH RILPIVIRINE AS A COMPLETE REGIMEN TO REPLACE THE CURRENT ARV REGIMEN IN VIROLOGICALLY SUPPRESSED PATIENTS ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TX FAILURE OR KNOWN SUBSTITUTIONS ASSOC. WITH RESISTANCE TO EITHER ARV | N | N | — | M-166 + I-758
Full coverage date: —
| Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 214397 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | MACLEODS PHARMS LTD | N | 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 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 (8)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-10-05 | LISTING_CONTEXT | Independent claims 6-9 explicitly claim dolutegravir and its sodium salt without indication or formulation limitations; correction certificate reviewed. | Source |
| PATENT | 2028-04-05 | CANONICAL_ANCHOR | Independent claims 6-9 explicitly claim dolutegravir and its sodium salt without indication or formulation limitations; correction certificate reviewed. | Source |
| PATENT | 2029-12-08 | FTO_TAIL | Dolutegravir sodium crystal/hydrate defined by diffraction, IR or NMR; corrected structures retained. | Source |
| PATENT | 2030-06-08 | FTO_TAIL | Dolutegravir sodium crystal/hydrate defined by diffraction, IR or NMR; corrected structures retained. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY (ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT SUBJECTS | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | FOR USE WITH RILPIVIRINE AS A COMPLETE REGIMEN TO REPLACE THE CURRENT ARV REGIMEN IN VIROLOGICALLY SUPPRESSED PATIENTS ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TX FAILURE OR KNOWN SUBSTITUTIONS ASSOC. WITH RESISTANCE TO EITHER ARV | Source |
| REGULATORY_EXCLUSIVITY | 2018-08-12 | CANONICAL_ANCHOR | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2028-04-05 | DECISION_BASIS | Rights after the canonical full-scope anchor require 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.