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Generic Baraclude Availability

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

BARACLUDE (entecavir - solution;oral)

BARACLUDE (entecavir - tablet;oral)

Has a generic version of Baraclude been approved?

A generic version of Baraclude 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 Baraclude and have been approved by the FDA:

entecavir tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: August 25, 2017
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: AMNEAL PHARMS
    Approval date: November 12, 2015
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: August 26, 2015
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: CIPLA LTD
    Approval date: December 6, 2016
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: August 21, 2015
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: PAR PHARM INC
    Approval date: November 23, 2016
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: PRINSTON INC
    Approval date: October 10, 2017
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: SANDOZ INC
    Approval date: May 11, 2017
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: August 26, 2014
    Strength(s): 0.5MG [AB], 1MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: June 23, 2017
    Strength(s): 0.5MG [AB], 1MG [AB]

Note: No generic formulation of the following product is available.

  • entecavir - solution;oral

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

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 20, 2017 - NEW PATIENT POPULATION
    • September 20, 2017 - PEDIATRIC EXCLUSIVITY
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.
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.