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Generic Mavyret Availability

Last updated on Oct 6, 2021.

Mavyret is a brand name of glecaprevir/pibrentasvir, approved by the FDA in the following formulation(s):

MAVYRET (glecaprevir; pibrentasvir - pellets;oral)

  • Manufacturer: ABBVIE INC
    Approval date: June 10, 2021
    Strength(s): 50MG;20MG/PACKET [RLD]

MAVYRET (glecaprevir; pibrentasvir - tablet;oral)

  • Manufacturer: ABBVIE INC
    Approval date: August 3, 2017
    Strength(s): 100MG;40MG [RLD]

Has a generic version of Mavyret been approved?

No. There is currently no therapeutically equivalent version of Mavyret available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Mavyret. 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.

  • Anti-viral compounds
    Patent 10,028,937
    Issued: July 24, 2018
    Assignee(s): AbbVie Inc.

    Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.

    Patent expiration dates:

    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
  • Patent 10028937*

    Patent expiration dates:

    • December 10, 2030
  • Anti-viral compounds
    Patent 10,039,754
    Issued: August 7, 2018
    Assignee(s): AbbVie Inc.

    Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.

    Patent expiration dates:

    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
  • Patent 10039754*

    Patent expiration dates:

    • December 10, 2030
  • Method for treating HCV
    Patent 10,286,029
    Issued: May 14, 2019
    Assignee(s): AbbVie Inc.

    The present invention features interferon-free therapies for the treatment of HCV. Preferably, the treatment is over a shorter duration of treatment, such as no more than 12 weeks. In one aspect, the treatment comprises administering at least two direct acting antiviral agents to a subject with HCV infection, wherein the treatment lasts for 12 weeks and does not include administration of either interferon or ribavirin, and said at least two direct acting antiviral agents comprise (a) Compound 1 or a pharmaceutically acceptable salt thereof and (b) Compound 2 or a pharmaceutically acceptable salt thereof.

    Patent expiration dates:

    • March 14, 2034
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
    • March 14, 2034
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
  • Patent 10286029*

    Patent expiration dates:

    • September 14, 2034
  • Macrocyclic proline derived HCV serine protease inhibitors
    Patent 8,648,037
    Issued: February 11, 2014
    Assignee(s): Enanta Pharmaceuticals, Inc.

    The present invention discloses compounds of Formula I or pharmaceutically acceptable salts, esters, or prodrugs thereof: which inhibit serine protease activity, particularly the activity of hepatitis C virus (HCV) NS3-NS4A protease. Consequently, the compounds of the present invention interfere with the life cycle of the hepatitis C virus and are also useful as antiviral agents. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HCV infection. The invention also relates to methods of treating an HCV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.

    Patent expiration dates:

    • January 19, 2032
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 19, 2032
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 19, 2032
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 19, 2032
      ✓ 
      Pediatric exclusivity
  • Anti-viral compounds
    Patent 8,937,150
    Issued: January 20, 2015
    Assignee(s): AbbVie Inc.

    Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.

    Patent expiration dates:

    • May 18, 2032
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • November 18, 2032
      ✓ 
      Pediatric exclusivity
  • Crystal forms
    Patent 9,321,807
    Issued: April 26, 2016
    Assignee(s): AbbVie Inc.

    The present invention features crystalline forms of Compound I. In one embodiment, a crystalline form of Compound I has characteristic peaks in the PXRD pattern as shown in any one of FIGS. 1-4.

    Patent expiration dates:

    • June 5, 2035
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • June 5, 2035
      ✓ 
      Drug substance
    • December 5, 2035
      ✓ 
      Pediatric exclusivity
  • Anti-viral compounds
    Patent 9,586,978
    Issued: March 7, 2017
    Assignee(s): AbbVie Inc.

    Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.

    Patent expiration dates:

    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG
    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG
    • June 10, 2030
      ✓ 
      Patent use: TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6
    • December 10, 2030
      ✓ 
      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:

    • August 6, 2021 - REVISIONS TO THE GLECAPREVIR/PIBRENTASVIR COMBINATION PRODUCT PRESCRIBING INFORMATION TO INCLUDE SAFETY AND EFFICACY DATA FROM THE HCV/HIV-1 COINFECTION STUDY M14-730 AND FROM THE LIVER AND RENAL TRANSPLANT STUDY M13-596
    • April 30, 2022 - NEW PATIENT POPULATION
    • August 3, 2022 - NEW CHEMICAL ENTITY
    • September 26, 2022 - EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY
    • October 30, 2022 - PEDIATRIC EXCLUSIVITY
    • February 3, 2023 - PEDIATRIC EXCLUSIVITY
    • March 26, 2023 - PEDIATRIC EXCLUSIVITY
    • April 10, 2023 - INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION
    • October 10, 2023 - PEDIATRIC EXCLUSIVITY
    • April 30, 2026 -
    • April 30, 2026 -
    • October 30, 2026 - 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.