Qsymia Patent Expiration

Qsymia is a drug owned by Vivus Inc. It is protected by 11 US drug patents filed from 2013 to 2015. Out of these, 6 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2029. Details of Qsymia's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6071537 Anticonvulsant derivatives useful in treating obesity
Jun, 2017

(7 years ago)

Expired
US7056890 Combination therapy for effecting weight loss and treating obesity
Jun, 2020

(4 years ago)

Expired
US7674776 Combination therapy for effecting weight loss and treating obesity
Jun, 2020

(4 years ago)

Expired
US7659256 Combination therapy for effecting weight loss and treating obesity
Jun, 2020

(4 years ago)

Expired
US7553818 Combination therapy for effecting weight loss and treating obesity
Jun, 2020

(4 years ago)

Expired
US9011906 Escalating dosing regimen for effecting weight loss and treating obesity
Jun, 2028

(3 years from now)

Active
US8895057 Escalating dosing regimen for effecting weight loss and treating obesity
Jun, 2028

(3 years from now)

Active
US8895058 Low dose topiramate/phentermine composition and methods of use thereof
Jun, 2028

(3 years from now)

Active
US9011905 Low dose topiramate/phentermine composition and methods of use thereof
Jun, 2028

(3 years from now)

Active
US8580298 Low dose topiramate/phentermine composition and methods of use thereof
May, 2029

(4 years from now)

Active
US8580299 Escalating dosing regimen for effecting weight loss and treating obesity
Jun, 2029

(4 years from now)

Active


FDA has granted several exclusivities to Qsymia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qsymia, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Qsymia.

Exclusivity Information

Qsymia holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Qsymia's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) Jul 17, 2015
New Patient Population(NPP) Jun 24, 2025

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US patents provide insights into the exclusivity only within the United States, but Qsymia is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Qsymia's family patents as well as insights into ongoing legal events on those patents.

Qsymia's family patents

Qsymia has patent protection in a total of 17 countries. It's US patent count contributes only to 39.3% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Qsymia.

Family Patents

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Generic Launch

Generic Release Date:

Qsymia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 14, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Qsymia Generics:

There are no approved generic versions for Qsymia as of now.

How can I launch a generic of Qsymia before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Qsymia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Qsymia's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Qsymia -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg 18 Jul, 2013 1 14 Jun, 2020 Extinguished




About Qsymia

Qsymia is a drug owned by Vivus Inc. It is used for managing weight in individuals with obesity or overweight-related comorbidities. Qsymia uses Phentermine Hydrochloride; Topiramate as an active ingredient. Qsymia was launched by Vivus in 2012.

Market Authorisation Date:

Qsymia was approved by FDA for market use on 17 July, 2012.

Active Ingredient:

Qsymia uses Phentermine Hydrochloride; Topiramate as the active ingredient. Check out other Drugs and Companies using Phentermine Hydrochloride; Topiramate ingredient

Treatment:

Qsymia is used for managing weight in individuals with obesity or overweight-related comorbidities.

Dosage:

Qsymia is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE Prescription ORAL
EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE Prescription ORAL
EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE Prescription ORAL
EQ 3.75MG BASE;23MG CAPSULE, EXTENDED RELEASE Prescription ORAL