Qsymia is a drug owned by Vivus Llc. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8580299 | Escalating dosing regimen for effecting weight loss and treating obesity |
Jun, 2029
(3 years from now) | Active |
| US8580298 | Low dose topiramate/phentermine composition and methods of use thereof |
May, 2029
(3 years from now) | Active |
| US9011905 | Low dose topiramate/phentermine composition and methods of use thereof |
Jun, 2028
(2 years from now) | Active |
| US9011906 | Escalating dosing regimen for effecting weight loss and treating obesity |
Jun, 2028
(2 years from now) | Active |
| US8895057 | Escalating dosing regimen for effecting weight loss and treating obesity |
Jun, 2028
(2 years from now) | Active |
| US8895058 | Low dose topiramate/phentermine composition and methods of use thereof |
Jun, 2028
(2 years from now) | Active |
| US7659256 | Combination therapy for effecting weight loss and treating obesity |
Jun, 2020
(5 years ago) |
Expired
|
| US7553818 | Combination therapy for effecting weight loss and treating obesity |
Jun, 2020
(5 years ago) |
Expired
|
| US7056890 | Combination therapy for effecting weight loss and treating obesity |
Jun, 2020
(5 years ago) |
Expired
|
| US7674776 | Combination therapy for effecting weight loss and treating obesity |
Jun, 2020
(5 years ago) |
Expired
|
| US6071537 | Anticonvulsant derivatives useful in treating obesity |
Jun, 2017
(8 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Qsymia's patents.
Latest Legal Activities on Qsymia's Patents
Given below is the list of recent legal activities going on the following patents of Qsymia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Oct, 2022 | US9011905 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Oct, 2022 | US9011906 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 May, 2022 | US8895058 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 May, 2022 | US8895057 (Litigated) |
| Expire Patent
Critical | 11 Apr, 2022 | US7674776 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 25 Oct, 2021 | US7674776 (Litigated) |
| Expire Patent
Critical | 02 Aug, 2021 | US7553818 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Apr, 2021 | US8580299 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Apr, 2021 | US8580298 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 15 Feb, 2021 | US7553818 (Litigated) |
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 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. 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 |
| M(M-308) | Sep 13, 2027 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Phentermine Hydrochloride; Topiramate is the generic name for the brand Qsymia. 2 different companies have already filed for the generic of Qsymia, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Qsymia's generic
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 Llc. 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 Llc in 2012.
Approval 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 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |