Topamax is a brand name of topiramate, approved by the FDA in the following formulation(s):
TOPAMAX (topiramate - capsule; oral)
Manufacturer: JANSSEN PHARMS
Approval date: October 26, 1998
Strength(s): 15MG [AB], 25MG [RLD][AB]
TOPAMAX (topiramate - tablet; oral)
Manufacturer: JANSSEN PHARMS
Approval date: December 24, 1996
Strength(s): 100MG [AB], 200MG [AB], 25MG [RLD][AB], 50MG [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: SANDOZ
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): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: APOTEX INC
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: AUROBINDO PHARMA
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: CIPLA LTD
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: GLENMARK GENERICS
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: INVAGEN PHARMS
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: MYLAN
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: RANBAXY
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB]
Manufacturer: SUN PHARM INDS LTD
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: TEVA
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: TORRENT PHARMS
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: UNICHEM
Approval date: March 27, 2009
Strength(s): 100MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: UPSHER SMITH
Approval date: January 7, 2010
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: WATSON LABS
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: WOCKHARDT USA
Approval date: September 1, 2010
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [AB]
Manufacturer: ZYDUS PHARMS USA INC
Approval date: March 27, 2009
Strength(s): 100MG [AB], 200MG [AB], 25MG [AB], 50MG [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✓
- April 13, 2016✓
- October 13, 2015
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✓
- April 13, 2016✓
- October 13, 2015
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✓
- April 13, 2016✓
- October 13, 2015
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✓
- September 1, 2019✓
- March 1, 2019
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✓
- April 13, 2016✓
- October 13, 2015
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:
- December 22, 2012 - INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
- June 22, 2013 - PEDIATRIC EXCLUSIVITY
See also...
- Topamax Consumer Information (Drugs.com)
- Topamax Consumer Information (Wolters Kluwer)
- Topamax Sprinkle Capsules Consumer Information (Wolters Kluwer)
- Topamax Consumer Information (Cerner Multum)
- Topamax Advanced Consumer Information (Micromedex)
- Topamax AHFS DI Monographs (ASHP)
- Topiramate Consumer Information (Wolters Kluwer)
- Topiramate Sprinkle Capsules Consumer Information (Wolters Kluwer)
- Topiramate Consumer Information (Cerner Multum)
- Topiramate Advanced Consumer Information (Micromedex)
- Topiramate AHFS DI Monographs (ASHP)
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