Product profile · United States

EPCLUSA

· Patent Litigation & Settlement History ↓

IngredientSOFOSBUVIR; VELPATASVIR

Application typeNDA

Application208341

Product001

Dosage formTABLET

RouteORAL

Strength400MG;100MG

Approval date2016-06-28

Marketing statusPrescription

Status event—

ApplicantGILEAD SCIENCES INC

Product source

Current GenericRadar decision

Year2033

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeTRUE_DS_PATENT

Anchor date2033-05-16

Patent anchor2033-05-16

Exclusivity anchor2021-06-28

Protection date2034-07-30

First Final ANDA—

Status event—

Canonical 2033-05-16; DEEP_REVIEW; latest post-anchor right 2034-07-30; Final exact ANDA link not identified; not certified generic absence.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8334270	2028-03-21	DS/DP/U U-1470	—	—	—	—	—	—
8580765	2028-03-21	DS/DP/U U-1470	—	—	—	—	—	—
8735372	2028-03-21	U U-1470	—	—	—	—	—	—
9085573	2028-03-21	DS/DP/U U-1470	—	—	—	—	—	—
8334270	2028-09-21	— —	—	—	—	—	2028-09-21	—
8334270	2028-09-21	ORANGE_BOOK U-1470	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2028-09-21	—
8580765	2028-09-21	— —	—	—	—	—	2028-09-21	—
8580765	2028-09-21	ORANGE_BOOK U-1470	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2028-09-21	—
8735372	2028-09-21	— —	—	—	—	—	2028-09-21	—
8735372	2028-09-21	ORANGE_BOOK U-1470	N	Y	DS_EQUIVALENT English description not available.	—	2028-09-21	—
9085573	2028-09-21	— —	—	—	—	—	2028-09-21	—
9085573	2028-09-21	ORANGE_BOOK U-1470	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2028-09-21	—
7964580	2029-03-26	DS/DP/U U-1470	—	—	—	—	—	—
8633309	2029-03-26	DS/DP/U U-1470	—	—	—	—	—	—
8889159	2029-03-26	DP/U U-1470	—	—	—	—	—	—
7964580	2029-09-26	— —	—	—	—	—	2029-09-26	—
7964580	2029-09-26	ORANGE_BOOK U-1470	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2029-09-26	—
8633309	2029-09-26	— —	—	—	—	—	2029-09-26	—
8633309	2029-09-26	ORANGE_BOOK U-1470	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2029-09-26	—
8889159	2029-09-26	— —	—	—	—	—	2029-09-26	—
8889159	2029-09-26	ORANGE_BOOK U-1470	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2029-09-26	—
9284342	2030-09-13	DS/DP/U U-1470	—	—	—	—	—	—
8618076	2030-12-11	DS/DP/U U-1470	—	—	—	—	—	—
9284342	2031-03-13	— —	—	—	—	—	2031-03-13	—
9284342	2031-03-13	ORANGE_BOOK U-1470	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2031-03-13	—
8618076	2031-06-11	— —	—	—	—	—	2031-06-11	—
8618076	2031-06-11	ORANGE_BOOK U-1470	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2031-06-11	—
8575135	2032-11-16	DS/DP/U U-1470	—	—	—	—	—	—
8921341	2032-11-16	DS/DP/U U-1470	—	—	—	—	—	—
8940718	2032-11-16	DS/DP/U U-1470	—	—	—	—	—	—
8575135	2033-05-16	— —	—	—	—	—	2033-05-16	—
8575135	2033-05-16	ORANGE_BOOK U-1470	Y	N	TRUE_DS English description not available.	—	2033-05-16	—
8921341	2033-05-16	— —	—	—	—	—	2033-05-16	—
8921341	2033-05-16	ORANGE_BOOK U-1470	Y	N	TRUE_DS English description not available.	—	2033-05-16	—
8940718	2033-05-16	— —	—	—	—	—	2033-05-16	—
8940718	2033-05-16	ORANGE_BOOK U-1470	Y	N	TRUE_DS English description not available.	—	2033-05-16	—
10086011	2034-01-30	U U-1470	—	—	—	—	—	—
11116783	2034-01-30	DP/U U-1470	—	—	—	—	—	—
9757406	2034-01-30	DP —	—	—	—	—	—	—
10086011	2034-07-30	— —	—	—	—	—	2034-07-30	—
10086011	2034-07-30	ORANGE_BOOK U-1470	N	N	U English description not available.	—	2034-07-30	—
11116783	2034-07-30	— —	—	—	—	—	2034-07-30	—
11116783	2034-07-30	ORANGE_BOOK U-1470	N	N	DP English description not available.	—	2034-07-30	—
9757406	2034-07-30	— —	—	—	—	—	2034-07-30	—
9757406	2034-07-30	ORANGE_BOOK —	N	N	DP English description not available.	—	2034-07-30	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2013-12-06	2018-12-06	English description not available.	Y	Y	—		Source
NPP	2017-08-01	2020-08-01	English description not available.	N	N	—		Source
NCE	2016-06-28	2021-06-28	English description not available.	Y	Y	—		Source
D-177	2019-11-15	2022-11-15	INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS	N	N	—		Source
NPP	2020-03-19	2023-03-19	English description not available.	N	N	—		Source
PED	2022-11-15	2023-05-15	English description not available.	N	N	—		Source
M-264	2020-07-14	2023-07-14	INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT	N	N	—		Source
PED	2023-03-19	2023-09-19	English description not available.	N	N	—		Source
PED	2023-07-14	2024-01-14	English description not available.	N	N	—		Source
M-277	2022-04-27	2025-04-27	UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER	N	N	—		Source
ODE-293	—	2027-03-19		—	—	—	—	Source
ODE-293	2020-03-19	2027-03-19	TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN	N	N	—		Source
PED	—	2027-09-19		—	—	—	—	Source
PED	2027-03-19	2027-09-19	English description not available.	N	N	—		Source
ODE-376	2021-06-10	2028-06-10	FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN	N	N	—		Source
PED	2028-06-10	2028-12-10	English description not available.	N	N	—		Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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 (30)

Type	Date	Role	Basis	Source
PATENT	2028-09-21	HISTORICAL_CONTEXT	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2028-09-21	HISTORICAL_CONTEXT	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2028-09-21	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2028-09-21	HISTORICAL_CONTEXT	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2029-09-26	HISTORICAL_CONTEXT	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2029-09-26	HISTORICAL_CONTEXT	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2029-09-26	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2031-03-13	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2031-06-11	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2033-05-16	CANONICAL_ANCHOR	English description not available.	Source
PATENT	2033-05-16	CANONICAL_ANCHOR	English description not available.	Source
PATENT	2033-05-16	CANONICAL_ANCHOR	English description not available.	Source
PATENT	2034-07-30	FTO_TAIL	English description not available.	Source
PATENT	2034-07-30	FTO_TAIL	English description not available.	Source
PATENT	2034-07-30	FTO_TAIL	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_STATUS	2033-05-16	CANONICAL_DECISION	Canonical 2033-05-16; DEEP_REVIEW; latest post-anchor right 2034-07-30; Final exact ANDA link not identified; not certified generic absence.	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.