Product profile · United States

GENVOYA

· Patent Litigation & Settlement History ↓

IngredientCOBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application typeNDA

Application207561

Product001

Dosage formTABLET

RouteORAL

Strength150MG;150MG;200MG;EQ 10MG BASE

Approval date2015-11-05

Marketing statusPrescription

Status event—

ApplicantGILEAD SCIENCES INC

Product source

Current GenericRadar decision

Year2033

SelectionCANDIDATE

ReviewFINAL

Anchor typeDS_EQUIVALENT_PATENT

Anchor date2033-02-15

Patent anchor2033-02-15

Exclusivity anchor2020-11-05

Protection date2033-04-06

First Final ANDA—

Status event—

User-directed 2026-10-24: GENVOYA 2033 CANDIDATE by year-level tail treatment. CAVEAT: standard GNR v2.3 exact-date rule would be DEEP_REVIEW because non-DS US10039718 ends 2033-04-06 after 2033-02-15 DS anchor. Apotex/MSN February 2025 settlement nonexclusive licensed entry 2032-08-06 or earlier under conditions; does not change patent anchor; source https://www.sec.gov/Archives/edgar/data/882095/000088209526000006/gild-20251231.htm

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 Claim 1 covers HIV treatment using an elvitegravir-containing compound; claims 5 and 30 include elvitegravir and acceptable salts. Classified TRUE_DS in the retained claim review.	—	2027-02-27	—
7635704	2027-04-26	— —	—	—	—	—	2027-04-26	—
7635704	2027-04-26	ORANGE_BOOK U-257	N	N	DP Claims 1-3 concern the XRPD-defined crystalline form of elvitegravir. Drug-product/form-specific patent, not a TRUE_DS anchor.	—	2027-04-26	—
8981103	2027-04-26	— —	—	—	—	—	2027-04-26	—
8981103	2027-04-26	ORANGE_BOOK —	N	N	DP Claim 1 is limited to an elvitegravir crystalline form with an XRPD peak at 8.54 degrees. Drug-product/form-specific patent, not a TRUE_DS anchor.	—	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	—
8754065	2032-08-15	DS/DP/U U-257	N	Y	DS_EQUIVALENT	—	—	—
9296769	2032-08-15	DS/DP/U U-257	—	—	—	—	—	—
10039718	2032-10-06	DP —	—	—	—	—	—	—
8754065	2033-02-15	— —	N	Y	DS_EQUIVALENT	—	2033-02-15	—
8754065	2033-02-15	ORANGE_BOOK U-257	N	Y	DS_EQUIVALENT Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2033-02-15	—
9296769	2033-02-15	— —	—	—	—	—	2033-02-15	—
9296769	2033-02-15	ORANGE_BOOK U-257	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2033-02-15	—
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	Source
NCE	2012-08-27	2017-08-27	NEW CHEMICAL ENTITY	Y	Y	2017-08-27	Source
NPP	2017-09-25	2020-09-25	English description not available.	N	N	—	Source
NCE	2015-11-05	2020-11-05	NEW CHEMICAL ENTITY	Y	Y	2020-11-05	Source
D-173	2018-12-10	2021-12-10	DOSING RECOMMENDATION FOR THE USE OF ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FIXED DOSE COMBINATION IN HIV-1 INFECTED ADULT PATIENTS WITH END-STAGE-RENAL DISEASE WHO ARE RECEIVING CHRONIC HEMODIALYSIS	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 (1)

Type	Date	Role	Basis	Source
PATENT	2033-02-15	CANONICAL_ANCHOR	Independent claim 1 is unrestricted tenofovir alafenamide hemifumarate; claim 11 adds a generic pharmaceutically acceptable excipient. GENVOYA label explicitly identifies the 2:1 fumarate / half-fumaric-acid composition. No XRPD constraint in these claims. FDA-listed expiry 2032-08-15 plus separately listed PED to 2033-02-15. Patent 10039718 is hydrophilic fumed silica-restricted formulation and remains a tail to 2033-04-06.	Source

Decision history

Current	Year	Status	Review	Anchor	Judged
Y	2033	CANDIDATE	FINAL	2033-02-15	2026-10-16 21:33:25
N	2030	DEEP_REVIEW	FINAL	2030-10-30	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.

Event date	Party	Event	Licensed entry	Evidence	Source
Not disclosed	Apotex Inc.; Apotex Corp.; MSN Laboratories Private Limited; MSN Life Sciences Private Ltd.; MSN Pharmaceuticals Inc.	SETTLEMENT Brand-level record; strength scope not established	2032-08-06	SOURCE_CONFIRMED	Source
February 2025 Gilead/Apotex/MSN US ANDA litigation settlement. NON-EXCLUSIVE LICENSE to specified patents concerning cobicistat on silicon dioxide and TAF for Apotex ANDA product, beginning 2032-08-06 or earlier under contractual conditions. NOT actual launch, FDA final approval, universal freedom to operate, or a replacement for the Orange Book patent anchor. 2018 Mylan settlement also disclosed; specific entry date not provided.