Medication Guide App

Generic Zyban Availability

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

ZYBAN (bupropion hydrochloride - tablet, extended release;oral)

Has a generic version of Zyban been approved?

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

bupropion hydrochloride tablet, extended release;oral

  • Manufacturer: ACTAVIS
    Approval date: March 12, 2008
    Strength(s): 150MG [AB2]
  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: March 24, 2009
    Strength(s): 150MG [AB2]
  • Manufacturer: ANCHEN PHARMS
    Approval date: June 9, 2011
    Strength(s): 150MG [AB2]
  • Manufacturer: IMPAX LABS
    Approval date: May 27, 2004
    Strength(s): 150MG [AB2]
  • Manufacturer: JUBILANT GENERICS
    Approval date: October 11, 2013
    Strength(s): 150MG [AB2]
  • Manufacturer: MYLAN
    Approval date: May 3, 2010
    Strength(s): 150MG [AB2]

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

  • Pharmaceutical composition containing bupropion hydrochloride and a stabilizer
    Patent 5,358,970
    Issued: October 25, 1994
    Inventor(s): Ruff; Michael D. & Kalidindi; Sanyasi R. & Sutton, Jr.; Joel E.
    Assignee(s): Burroughs Wellcome Co.
    This application discloses a method of inhibiting degradation of the antidepressant bupropion hydrochloride in a solid pharmaceutical formulation, so that the pharmaceutical formulation will maintain at least 80% of its initial bupropion potency after one year.
    Patent expiration dates:
    • August 12, 2013
  • Controlled sustained release tablets containing bupropion
    Patent 5,427,798
    Issued: June 27, 1995
    Inventor(s): Ludwig; Jennie Sue G. & Bass, Jr.; William L. & Sutton, Jr.; Joel E.
    Assignee(s): Burroughs Wellcome Co.
    A controlled sustained release tablet having at least one year shelf life and containing bupropion hydrochloride, hydroxypropyl methylcellulose and cysteine hydrochloride or glycine hydrochloride with the tablet having a surface area to volume ratio to effectively control bupropion hydrochloride release in the body.
    Patent expiration dates:
    • August 12, 2013
  • Stabilized pharmaceutical composition containing bupropion
    Patent 5,731,000
    Issued: March 24, 1998
    Inventor(s): Ruff; Michael David & Kalidindi; Sanyasi Raju & Sutton, Jr.; Joel Elmore
    Assignee(s): Glaxo Wellcome Inc.
    This application discloses a method of inhibiting degradation of the antidepressant bupropion hydrochloride in a solid pharmaceutical formulation, so that the pharmaceutical formulation will maintain at least 80% of its initial bupropion potency after one year.
    Patent expiration dates:
    • August 12, 2013
  • Stabilized pharmaceutical
    Patent 5,763,493
    Issued: June 9, 1998
    Inventor(s): Ruff; Michael D. & Kalidindi; Sanvasi R. & Sutton, Jr.; Joel Elmore
    Assignee(s): Glaxo Wellcome Inc.
    This application discloses a method of inhibiting degradation of the antidepressant bupropion hydrochloride in a solid pharmaceutical formulation, so that the pharmaceutical formulation will maintain at least 80% of its initial bupropion potency after one year.
    Patent expiration dates:
    • August 12, 2013

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.
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.
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