Treximet is a drug owned by Currax Pharmaceuticals Llc. It is protected by 10 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 02, 2026. Details of Treximet'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). | |||
|
US7332183 (Pediatric) | Multilayer dosage forms containing NSAIDs and triptans |
Apr, 2026
(1 year, 3 months from now) | Active |
| US7332183 | Multilayer dosage forms containing NSAIDs and triptans |
Oct, 2025
(9 months from now) | Active |
|
US8022095 (Pediatric) | Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs |
Feb, 2018
(6 years ago) |
Expired
|
|
US6586458 (Pediatric) | Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs |
Feb, 2018
(6 years ago) |
Expired
|
|
US6060499 (Pediatric) | Anti-migraine methods and compositions using 5-HT agonists with long-acting NSAIDs |
Feb, 2018
(6 years ago) |
Expired
|
|
US5872145 (Pediatric) | Formulation of 5-HT agonist and NSAID for treatment of migraine |
Feb, 2018
(6 years ago) |
Expired
|
| US6586458 | Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs |
Aug, 2017
(7 years ago) |
Expired
|
| US8022095 | Methods of treating headaches using 5-HT agonists in combination with long-acting NSAIDs |
Aug, 2017
(7 years ago) |
Expired
|
| US6060499 | Anti-migraine methods and compositions using 5-HT agonists with long-acting NSAIDs |
Aug, 2017
(7 years ago) |
Expired
|
| US5872145 | Formulation of 5-HT agonist and NSAID for treatment of migraine |
Aug, 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 Treximet's patents.
Latest Legal Activities on Treximet's Patents
Given below is the list of recent legal activities going on the following patents of Treximet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 28 Oct, 2019 | US8022095 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Aug, 2019 | US7332183 |
| Maintenance Fee Reminder Mailed Critical | 13 May, 2019 | US8022095 |
| Request for Trial Denied Critical | 06 May, 2016 | US7332183 |
| Petition Requesting Trial | 12 Nov, 2015 | US7332183 |
| Email Notification Critical | 04 Sep, 2012 | US7332183 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Sep, 2012 | US7332183 |
| Correspondence Address Change Critical | 01 Sep, 2012 | US7332183 |
| Email Notification Critical | 21 Sep, 2011 | US8022095 |
| Recordation of Patent Grant Mailed Critical | 20 Sep, 2011 | US8022095 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Treximet and ongoing litigations to help you estimate the early arrival of Treximet generic.
Treximet's Litigations
Treximet been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 12, 2015, against patent number US7332183. The petitioner Graybar Pharmaceuticals, LLC, challenged the validity of this patent, with POZEN Inc. as the respondent. Click below to track the latest information on how companies are challenging Treximet's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7332183 | November, 2015 |
Terminated-Denied
(06 May, 2016) | POZEN Inc. | Graybar Pharmaceuticals, LLC |
FDA has granted some exclusivities to Treximet. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Treximet, 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 Treximet.
Exclusivity Information
Treximet holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Treximet's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 14, 2018 |
| Pediatric Exclusivity(PED) | Nov 14, 2018 |
US patents provide insights into the exclusivity only within the United States, but Treximet 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 Treximet's family patents as well as insights into ongoing legal events on those patents.
Treximet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Treximet's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 02, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Treximet Generic API suppliers:
Naproxen Sodium; Sumatriptan Succinate is the generic name for the brand Treximet. 3 different companies have already filed for the generic of Treximet, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Treximet's generic
How can I launch a generic of Treximet before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Treximet's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Treximet'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 Treximet -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/85 mg | 23 Jul, 2008 | 1 | 02 Oct, 2025 | Extinguished |
Alternative Brands for Treximet
Treximet which is used for the treatment of migraines., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Treximet
Treximet is a drug owned by Currax Pharmaceuticals Llc. It is used for the treatment of migraines. Treximet uses Naproxen Sodium; Sumatriptan Succinate as an active ingredient. Treximet was launched by Currax in 2015.
Approval Date:
Treximet was approved by FDA for market use on 14 May, 2015.
Active Ingredient:
Treximet uses Naproxen Sodium; Sumatriptan Succinate as the active ingredient. Check out other Drugs and Companies using Naproxen Sodium; Sumatriptan Succinate ingredient
Treatment:
Treximet is used for the treatment of migraines.
Dosage:
Treximet is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG;EQ 85MG BASE | TABLET | Prescription | ORAL |
| 60MG;EQ 10MG BASE | TABLET | Discontinued | ORAL |