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Generic Zepatier Availability

Zepatier is a brand name of elbasvir/grazoprevir, approved by the FDA in the following formulation(s):

ZEPATIER (elbasvir; grazoprevir - tablet;oral)

Has a generic version of Zepatier been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zepatier. 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: About generic drugs.

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.

  • Macrocyclic quinoxaline compounds as HCV NS3 protease inhibitors
    Patent 7,973,040
    Issued: July 5, 2011
    Inventor(s): Harper; Steven & Summa; Vincenzo & Liverton; Nigel J. & McCauley; John A.
    Assignee(s): Merck Sharp & Dohme Corp. Istituto di Ricerche di Biologia Molecolare P. Angeletti SpA
    The present invention relates to macrocyclic a compound of formula (I) and its use as inhibitors of the hepatitis C virus (HCV) NS3 protease, and in treating or preventing HCV infections.
    Patent expiration dates:
    • July 24, 2029
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      Patent use: TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
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      Drug substance
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      Drug product
  • Inhibitors of hepatitis C virus replication
    Patent 8,871,759
    Issued: October 28, 2014
    Assignee(s): Merck Sharp & Dohme Corp.
    The present invention relates to compounds of formula (I) that are useful as hepatitis C virus (HCV) NS5A inhibitors, the synthesis of such compounds, and the use of such compounds for inhibiting HCV NS5A activity, for treating or preventing HCV infections and for inhibiting HCV viral replication and/or viral production in a cell-based system.
    Patent expiration dates:
    • May 4, 2031
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      Patent use: TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
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      Drug substance
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      Drug product

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:
    • January 28, 2021 - NEW CHEMICAL ENTITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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