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
(4 years from now) | Active |
| US8580298 | Low dose topiramate/phentermine composition and methods of use thereof |
May, 2029
(4 years from now) | Active |
| US9011905 | Low dose topiramate/phentermine composition and methods of use thereof |
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 |
| 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 |
| US7056890 | 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
|
| 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
|
| US6071537 | Anticonvulsant derivatives useful in treating obesity |
Jun, 2017
(7 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 1 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. 1 company has already filed for the generic of Qsymia. 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 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 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 |