Generic Epclusa Availability
Last updated on Sep 6, 2023.
Epclusa is a brand name of sofosbuvir/velpatasvir, approved by the FDA in the following formulation(s):
EPCLUSA (sofosbuvir; velpatasvir - pellets;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: June 10, 2021
Strength(s): 150MG;37.5MG/PACKET [RLD], 200MG;50MG/PACKET [RLD]
EPCLUSA (sofosbuvir; velpatasvir - tablet;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: June 28, 2016
Strength(s): 400MG;100MG [RLD] -
Manufacturer: GILEAD SCIENCES INC
Approval date: March 19, 2020
Strength(s): 200MG;50MG [RLD]
Has a generic version of Epclusa been approved?
An Authorized Generic version of Epclusa has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- Velpatasvir and Sofosbuvir ORAL TABLET, FILM COATED 400; 100 mg/1; mg
Asegua Therapeutics LLC
NDC Code: 726262701
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Epclusa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Patent 10,086,011
Patent expiration dates:
- January 30, 2034✓
- January 30, 2034
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Patent 10086011*
Patent expiration dates:
- July 30, 2034
- July 30, 2034
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Patent 11,116,783
Patent expiration dates:
- January 30, 2034✓✓
- January 30, 2034
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Patent 11116783*
Patent expiration dates:
- July 30, 2034
- July 30, 2034
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Patent 11,707,479
Patent expiration dates:
- January 30, 2034✓✓
- January 30, 2034
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Patent 11707479*
Patent expiration dates:
- July 30, 2034
- July 30, 2034
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Patent 7,964,580
Patent expiration dates:
- March 26, 2029✓✓✓
- September 26, 2029✓
- March 26, 2029
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Patent 8,334,270
Patent expiration dates:
- March 21, 2028✓✓✓
- September 21, 2028✓
- March 21, 2028
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Patent 8,575,135
Patent expiration dates:
- November 16, 2032✓✓✓
- May 16, 2033✓
- November 16, 2032
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Patent 8,580,765
Patent expiration dates:
- March 21, 2028✓✓✓
- September 21, 2028✓
- March 21, 2028
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Patent 8,618,076
Patent expiration dates:
- December 11, 2030✓✓✓
- June 11, 2031✓
- December 11, 2030
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Patent 8,633,309
Patent expiration dates:
- March 26, 2029✓✓✓
- September 26, 2029✓
- March 26, 2029
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Patent 8,735,372
Patent expiration dates:
- March 21, 2028✓
- September 21, 2028✓
- March 21, 2028
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Patent 8,889,159
Patent expiration dates:
- March 26, 2029✓✓
- September 26, 2029✓
- March 26, 2029
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Patent 8,921,341
Patent expiration dates:
- November 16, 2032✓✓✓
- May 16, 2033✓
- November 16, 2032
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Patent 8,940,718
Patent expiration dates:
- November 16, 2032✓✓✓
- May 16, 2033✓
- November 16, 2032
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Patent 9,085,573
Patent expiration dates:
- March 21, 2028✓✓✓
- September 21, 2028✓
- March 21, 2028
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Patent 9,284,342
Patent expiration dates:
- September 13, 2030✓✓✓
- March 13, 2031✓
- September 13, 2030
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Patent 9,757,406
Patent expiration dates:
- January 30, 2034✓
- July 30, 2034✓
- January 30, 2034
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- March 19, 2023 - NEW PATIENT POPULATION
- March 19, 2023 - NEW STRENGTH
- May 15, 2023 - PEDIATRIC EXCLUSIVITY
- July 14, 2023 - 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
- September 19, 2023 - PEDIATRIC EXCLUSIVITY
- January 14, 2024 - PEDIATRIC EXCLUSIVITY
- April 27, 2025 - 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 TRE
- March 19, 2027 - 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
- September 19, 2027 - PEDIATRIC EXCLUSIVITY
- June 10, 2028 - 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 CIR
- December 10, 2028 - PEDIATRIC EXCLUSIVITY
More about Epclusa (sofosbuvir / velpatasvir)
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- During pregnancy
- Support group
- FDA approval history
- Drug class: antiviral combinations
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.