Skip to main content

Generic Epclusa Availability

Last updated on Sep 8, 2022.

Epclusa is a brand name of sofosbuvir/velpatasvir, approved by the FDA in the following formulation(s):

EPCLUSA (sofosbuvir; velpatasvir - pellets;oral)

  • 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)

  • 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.

  • Combination formulation of two antiviral compounds
    Patent 10,086,011
    Issued: October 2, 2018
    Assignee(s): Gilead Pharmasset LLC

    Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

    Patent expiration dates:

    • January 30, 2034
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
  • Patent 10086011*

    Patent expiration dates:

    • July 30, 2034
  • Patent 11,116,783

    Patent expiration dates:

    • January 30, 2034
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug product
  • Patent 11116783*

    Patent expiration dates:

    • July 30, 2034
  • Nucleoside phosphoramidate prodrugs
    Patent 7,964,580
    Issued: June 21, 2011
    Inventor(s): Sofia; Michael Joseph & Du; Jinfa & Wang; Peiyuan
    Assignee(s): Pharmasset, Inc.

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 26, 2029
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 26, 2029
      ✓ 
      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 8,334,270
    Issued: December 18, 2012
    Inventor(s): Sofia; Michael Joseph & Du; Jinfa & Wang; Peiyuan & Nagarathnam; Dhanapalan
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 21, 2028
      ✓ 
      Pediatric exclusivity
  • Antiviral compounds
    Patent 8,575,135
    Issued: November 5, 2013
    Assignee(s): Gilead Sciences, Inc.

    The disclosure is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • November 16, 2032
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 16, 2033
      ✓ 
      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 8,580,765
    Issued: November 12, 2013
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 21, 2028
      ✓ 
      Pediatric exclusivity
  • Nucleoside phosphoramidates
    Patent 8,618,076
    Issued: December 31, 2013
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are nucleoside phosphoramidates and their use as agents for treating viral diseases. These compounds are inhibitors of RNA-dependent RNA viral replication and are useful as inhibitors of HCV NS5B polymerase, as inhibitors of HCV replication and for treatment of hepatitis C infection in mammals.

    Patent expiration dates:

    • December 11, 2030
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • June 11, 2031
      ✓ 
      Pediatric exclusivity
  • Nucleoside phosphoramidates
    Patent 8,633,309
    Issued: January 21, 2014
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are nucleoside phosphoramidates and their use as agents for treating viral diseases. These compounds are inhibitors of RNA-dependent 5 RNA viral replication and are useful as inhibitors of HCV NS5B polymerase, as inhibitors of HCV replication and for treatment of hepatitis C infection in mammals.

    Patent expiration dates:

    • March 26, 2029
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 26, 2029
      ✓ 
      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 8,735,372
    Issued: May 27, 2014
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
    • September 21, 2028
      ✓ 
      Pediatric exclusivity
  • Compositions and methods for treating hepatitis C virus
    Patent 8,889,159
    Issued: November 18, 2014
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are a composition and unit dosage form for the treatment of hepatitis C virus (HCV) infection comprising GS-7977 and at least one pharmaceutically acceptable excipient, as well as methods for making said composition and unit dosage form. Also disclosed herein is a method of treating a subject, preferably a human, infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period.

    Patent expiration dates:

    • March 26, 2029
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug product
    • September 26, 2029
      ✓ 
      Pediatric exclusivity
  • Antiviral compounds
    Patent 8,921,341
    Issued: December 30, 2014
    Assignee(s): Gilead Pharmasset LLC

    The disclosure is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • November 16, 2032
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 16, 2033
      ✓ 
      Pediatric exclusivity
  • Antiviral compounds
    Patent 8,940,718
    Issued: January 27, 2015
    Assignee(s): Gilead Pharmasset LLC

    The disclosure is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • November 16, 2032
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 16, 2033
      ✓ 
      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 9,085,573
    Issued: July 21, 2015
    Assignee(s): GILEAD PHARMASSET LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 21, 2028
      ✓ 
      Pediatric exclusivity
  • Nucleoside phosphoramidates
    Patent 9,284,342
    Issued: March 15, 2016
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are nucleoside phosphoramidates and their use as agents for treating viral diseases. These compounds are inhibitors of RNA-dependent RNA viral replication and are useful as inhibitors of HCV NS5B polymerase, as inhibitors of HCV replication and for treatment of hepatitis C infection in mammals.

    Patent expiration dates:

    • September 13, 2030
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • March 13, 2031
      ✓ 
      Pediatric exclusivity
  • Combination formulation of two antiviral compounds
    Patent 9,757,406
    Issued: September 12, 2017
    Assignee(s): Gilead Pharmasset LLC

    Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

    Patent expiration dates:

    • January 30, 2034
      ✓ 
      Drug product
    • July 30, 2034
      ✓ 
      Pediatric exclusivity

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:

    • November 15, 2022 - 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
    • March 19, 2023 - NEW STRENGTH
    • March 19, 2023 - NEW PATIENT POPULATION
    • 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

Glossary

Term Definition
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.