Medication Guide App

Generic Copegus Availability

Copegus is a brand name of ribavirin, approved by the FDA in the following formulation(s):

COPEGUS (ribavirin - tablet;oral)

  • Manufacturer: ROCHE
    Approval date: December 3, 2002
    Strength(s): 200MG [AB]

Has a generic version of Copegus been approved?

A generic version of Copegus has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Copegus and have been approved by the FDA:

ribavirin tablet;oral

  • Manufacturer: AUROBINDO PHARMA
    Approval date: September 17, 2009
    Strength(s): 200MG [AB]
  • Manufacturer: SANDOZ
    Approval date: October 3, 2006
    Strength(s): 200MG [AB]
  • Manufacturer: SANDOZ
    Approval date: August 12, 2014
    Strength(s): 200MG [AB]
  • Manufacturer: TEVA
    Approval date: December 5, 2005
    Strength(s): 200MG [AB]
  • Manufacturer: THREE RIVERS PHARMS
    Approval date: December 5, 2005
    Strength(s): 200MG [AB]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: December 5, 2005
    Strength(s): 200MG [AB]

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

There are no current U.S. patents associated with Copegus.

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 9, 2014 -


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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.