Generic Qsymia Availability
Last updated on Apr 10, 2025.
Qsymia is a brand name of phentermine/topiramate, approved by the FDA in the following formulation(s):
QSYMIA (phentermine hydrochloride; topiramate - capsule, extended release;oral)
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Manufacturer: VIVUS LLC
Approval date: July 17, 2012
Strength(s): EQ 3.75MG BASE;23MG [RLD] [AB], EQ 7.5MG BASE;46MG [RLD] [AB], EQ 11.25MG BASE;69MG [RLD] [AB], EQ 15MG BASE;92MG [RLD] [AB]
Is there a generic version of Qsymia available?
A generic version of Qsymia 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 Qsymia and have been approved by the FDA:
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE (phentermine hydrochloride; topiramate capsule, extended release;oral)
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Manufacturer: ACTAVIS LABS FL INC
Approval date: June 25, 2024
Strength(s): EQ 3.75MG BASE;23MG [AB], EQ 7.5MG BASE;46MG [AB], EQ 11.25MG BASE;69MG [AB], EQ 15MG BASE;92MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Qsymia. 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 FAQ.
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.
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Low dose topiramate/phentermine composition and methods of use thereof
Patent 8,580,298
Issued: November 12, 2013
Inventor(s): Najaraian Thomas & Tam Peter Y. & Wilson Leland F.
Assignee(s): Vivus, Inc.A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.
Patent expiration dates:
- May 15, 2029✓
- May 15, 2029
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Escalating dosing regimen for effecting weight loss and treating obesity
Patent 8,580,299
Issued: November 12, 2013
Inventor(s): Najarian Thomas & Tam Peter Y. & Wilson Leland F.
Assignee(s): Vivus, Inc.The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.
Patent expiration dates:
- June 14, 2029✓
- June 14, 2029
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Escalating dosing regimen for effecting weight loss and treating obesity
Patent 8,895,057
Issued: November 25, 2014
Inventor(s): Najarian Thomas & Tam Peter Y. & Wilson Leland F.
Assignee(s): Vivus, Inc.The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.
Patent expiration dates:
- June 9, 2028✓
- June 9, 2028
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Low dose topiramate/phentermine composition and methods of use thereof
Patent 8,895,058
Issued: November 25, 2014
Inventor(s): Najarian Thomas & Tam Peter Y. & Wilson Leland F.
Assignee(s): Vivus, Inc.A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.
Patent expiration dates:
- June 9, 2028✓
- June 9, 2028
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Low dose topiramate/phentermine composition and methods of use thereof
Patent 9,011,905
Issued: April 21, 2015
Inventor(s): Najarian Thomas & Tam Peter Y. & Wilson Leland F.
Assignee(s): Vivus, Inc.A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.
Patent expiration dates:
- June 9, 2028✓
- June 9, 2028
-
Escalating dosing regimen for effecting weight loss and treating obesity
Patent 9,011,906
Issued: April 21, 2015
Inventor(s): Najarian Thomas & Tam Peter Y. & Wilson Leland F.
Assignee(s): Vivus, Inc.The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.
Patent expiration dates:
- June 9, 2028✓
- June 9, 2028
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:
- June 24, 2025 - NEW PATIENT POPULATION
- September 13, 2027 - INFORMATION ADDED TO THE LABELING TO DESCRIBE A CLINICAL STUDY
More about Qsymia (phentermine / topiramate)
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Glossary
Term | Definition |
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Drug Patent | A 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 Exclusivity | Exclusivity 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. |
RLD | A 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. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.