Generic Topamax Availability

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

TOPAMAX (topiramate - capsule;oral)

TOPAMAX (topiramate - tablet;oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: December 24, 1996
    Strength(s): 25MG [AB], 50MG [AB], 100MG [RLD] [AB], 200MG [AB]

Has a generic version of Topamax been approved?

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

topiramate capsule;oral

  • Manufacturer: MYLAN
    Approval date: October 14, 2009
    Strength(s): 15MG [AB], 25MG [AB]
  • Manufacturer: TEVA
    Approval date: April 17, 2009
    Strength(s): 15MG [AB], 25MG [AB]
  • Manufacturer: WATSON LABS
    Approval date: April 15, 2009
    Strength(s): 15MG [AB], 25MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: October 14, 2009
    Strength(s): 15MG [AB], 25MG [AB]

topiramate tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: ACTIVIS TOTOWA LLC
    Approval date: February 27, 2013
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: CIPLA LTD
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]

TOPIRAMATE (topiramate tablet;oral)

  • Manufacturer: HIKMA PHARMS
    Approval date: November 25, 2013
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]

topiramate tablet;oral

  • Manufacturer: INVAGEN PHARMS
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: LUPIN
    Approval date: September 11, 2013
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: MYLAN
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: RANBAXY
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: SUN PHARM INDS LTD
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: TEVA
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: TORRENT PHARMS
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: UNICHEM LABS LTD
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB]
  • Manufacturer: UNICHEM LABS LTD
    Approval date: February 19, 2013
    Strength(s): 200MG [AB]
  • Manufacturer: UPSHER SMITH
    Approval date: January 7, 2010
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: WOCKHARDT USA
    Approval date: September 1, 2010
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: March 27, 2009
    Strength(s): 25MG [AB], 50MG [AB], 100MG [AB], 200MG [AB]

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

  • Treatment of migraine
    Patent 5,998,380
    Issued: December 7, 1999
    Inventor(s): Ehrenberg; Bruce L. & Wagner; Anita K.
    Assignee(s): New England Medical Center Hospitals, Inc.
    A method for treating migraine in non-epileptic subjects which involves administering to subjects an effective amount of a pharmaceutical composition comprising a sulfamate of the following formula: ##STR1##
    Patent expiration dates:
    • October 13, 2015
      ✓ 
      Patent use: PROPHYLACTIC TREATMENT OF MIGRAINE
    • April 13, 2016
      ✓ 
      Pediatric exclusivity
  • Migraine treatment method using topiramate and related compounds
    Patent 6,503,884
    Issued: January 7, 2003
    Inventor(s): Bruce L.; Ehrenberg & Anita K.; Wagner
    Assignee(s): New England Medical Center Hospitals, Inc.
    A method for treating migraine in non-epileptic subjects which involves administering to subjects an effective amount of a pharmaceutical composition comprising a sulfamate of the following formula:
    Patent expiration dates:
    • October 13, 2015
      ✓ 
      Patent use: PROPHYLACTIC TREATMENT OF MIGRAINE
    • April 13, 2016
      ✓ 
      Pediatric exclusivity
  • Treatment of migraine
    Patent 7,018,983
    Issued: March 28, 2006
    Inventor(s): Ehrenberg; Bruce L. & Wagner; Anita K.
    Assignee(s): New England Medical Center Hospitals, Inc.
    A method for treating migraine in non-epileptic subjects which involves administering to subjects an effective amount of a pharmaceutical composition comprising a sulfamate of the following formula:
    Patent expiration dates:
    • October 13, 2015
      ✓ 
      Patent use: PROPHYLACTIC TREATMENT OF MIGRAINE
    • April 13, 2016
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical composition of topiramate
    Patent 7,125,560
    Issued: October 24, 2006
    Inventor(s): Thakur; Madhav S. & Kotwal; Pramod M. & Gibbs; Irwin S.
    Assignee(s): Ortho-McNeil Pharmaceutical, Inc.
    The invention is directed to a pharmaceutical composition of topiramate, an anticonvulsant which is useful for treating epilepsy. More specifically, the present invention provides a solid dosage formulation of topiramate intended primarily for use by pediatric patients, or for patients who have difficulty swallowing tablets. Processes for preparing the pharmaceutical composition are also described.
    Patent expiration dates:
    • March 1, 2019
      ✓ 
      Patent use: TREATMENT OF SEIZURES
    • September 1, 2019
      ✓ 
      Pediatric exclusivity
  • Treatment of migraine
    Patent 7,498,311
    Issued: March 3, 2009
    Inventor(s): Ehrenberg; Bruce L. & Wagner; Anita K.
    Assignee(s): New England Medical Center Hospitals, Inc.
    A method for treating migraine in non-epileptic subjects which involves administering to subjects an effective amount of a pharmaceutical composition comprising a sulfamate of the following formula:
    Patent expiration dates:
    • October 13, 2015
      ✓ 
      Patent use: PROPHYLACTIC TREATMENT OF MIGRAINE
    • April 13, 2016
      ✓ 
      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:
    • July 15, 2014 -

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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