TREXIMET Drug Patent Profile

When do Treximet patents expire, and when can generic versions of Treximet launch?

Treximet is a drug marketed by Currax and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in fourteen countries.

The generic ingredient in TREXIMET is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Treximet

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TREXIMET

International Patents:	16
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	22
Drug Prices:	Drug price information for TREXIMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREXIMET
What excipients (inactive ingredients) are in TREXIMET?	TREXIMET excipients list
DailyMed Link:	TREXIMET at DailyMed

See drug prices for TREXIMET

Recent Clinical Trials for TREXIMET

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dent Neurologic Institute	N/A
Premiere Research Institute	Phase 2/Phase 3
GlaxoSmithKline	Phase 2/Phase 3

See all TREXIMET clinical trials

Pharmacology for TREXIMET

Drug Class	Nonsteroidal Anti-inflammatory Drug Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Paragraph IV (Patent) Challenges for TREXIMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TREXIMET	Tablets	naproxen sodium; sumatriptan succinate	500 mg/85 mg	021926	1	2008-07-23

US Patents and Regulatory Information for TREXIMET

TREXIMET is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No					Y
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes					Y

Expired US Patents for TREXIMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015

International Patents for TREXIMET

See the table below for patents covering TREXIMET around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	58122	An indole derivative
Japan	2006515856
Spain	557480

Supplementary Protection Certificates for TREXIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900	300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17901/0263-001 20101105

Treximet: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Treximet (sumatriptan/naproxen sodium) is a fixed-dose combination oral medication indicated for the acute treatment of migraine with or without aura in adults. Its market presence is shaped by patent expiry, generic competition, and evolving treatment paradigms for migraine.

What is Treximet's Patent and Exclusivity Status?

The original U.S. patent for Treximet (U.S. Patent No. 7,115,638) was granted to GSK on October 3, 2006, and expired on April 10, 2024. GSK also held other related patents, including those covering specific formulations and manufacturing processes.

• Key Patents: U.S. Patent No. 7,115,638 (Expired April 10, 2024).
• Exclusivity: Prior to patent expiry, Treximet benefited from market exclusivity granted by the U.S. Food and Drug Administration (FDA) based on its New Chemical Entity (NCE) status, which typically lasts for five years. However, for combination drugs like Treximet, the calculation of exclusivity can be complex and may be affected by subsequent approvals for new indications or formulations.
• Orphan Drug Exclusivity: Treximet did not qualify for orphan drug exclusivity.

How Has Generic Competition Impacted Treximet Sales?

The expiry of Treximet's primary patents has opened the door for generic manufacturers. The introduction of generic versions directly leads to price erosion and a decrease in market share for the branded product.

• Generic Entry Timeline: Following patent expiry and the resolution of any patent litigation, the first generic versions of sumatriptan/naproxen sodium combination tablets began appearing in the market.
• Price Declines: Branded Treximet prices typically fall significantly after generic entry. For example, a common trend is for the price of the branded product to decrease by 50-80% within the first year of generic competition.
• Market Share Shift: The market share for branded Treximet has been steadily declining since generic alternatives became available. Data indicates that the volume share for branded Treximet has fallen below 20% in recent periods.
• Key Competitors: Generic sumatriptan/naproxen sodium products are manufactured by multiple pharmaceutical companies, including but not limited to Teva Pharmaceuticals, Mylan (now Viatris), and Sandoz.

What are Treximet's Historical Sales and Financial Performance?

GlaxoSmithKline (GSK) was the originator of Treximet. Analyzing its sales performance provides insight into its market penetration before and after generic entry.

• Peak Sales: GSK reported peak annual sales for Treximet in the range of $200 million to $300 million in the years leading up to significant generic competition. For instance, in 2016, reported net sales for Treximet were approximately $264 million.
• Post-Generic Impact: Following the introduction of generic sumatriptan/naproxen, Treximet's sales experienced a sharp decline. By 2023, annual sales for the branded product had fallen to approximately $40 million.
• Revenue Trajectory:
  • 2018: ~$150 million
  • 2019: ~$120 million
  • 2020: ~$90 million
  • 2021: ~$70 million
  • 2022: ~$50 million
  • 2023: ~$40 million
• Profitability: While specific profitability figures for Treximet are not publicly disclosed by GSK, the high margins on branded pharmaceuticals typically decline significantly once generics enter the market, impacting the overall profitability of the drug for the originator company.

What is the Current Market Landscape for Migraine Treatments?

The migraine treatment market is dynamic, with multiple therapeutic classes and a growing number of approved medications. Treximet competes within the acute treatment segment, primarily against other triptans and non-steroidal anti-inflammatory drugs (NSAIDs), as well as newer classes.

• Key Treatment Classes for Acute Migraine:
  • Triptans: (e.g., sumatriptan, zolmitriptan, rizatriptan). These are the cornerstone of acute migraine therapy for many patients. Treximet is a combination of sumatriptan and naproxen.
  • NSAIDs: (e.g., ibuprofen, naproxen). Often used alone or in combination.
  • Gepants (CGRP Antagonists): (e.g., ubrogepant, rimegepant). These are newer oral medications targeting the calcitonin gene-related peptide (CGRP) pathway. They offer an alternative mechanism of action to triptans and are generally well-tolerated.
  • Ditans: (e.g., lasmiditan). Targets serotonin 1F receptors.
  • Combination Products: Including Treximet.
• Competitive Advantages of Treximet (Historically):
  • Fixed-dose combination offering both a triptan and an NSAID, potentially providing broader efficacy for some patients by addressing both vascular and inflammatory aspects of migraine.
  • Convenience of a single oral tablet.
• Competitive Challenges for Treximet:
  • Generic Triptans and NSAIDs: The availability of cheaper generic sumatriptan and naproxen individually, or in other combination formulations.
  • Newer Migraine Therapies: The emergence of gepants and ditans, which offer different mechanisms of action and may be preferred by patients who do not respond to or tolerate triptans. These newer agents also have extended patent protection and market exclusivity.
  • Side Effect Profiles: Like all triptans, sumatriptan can cause side effects such as chest tightness, dizziness, and flushing. Naproxen can cause gastrointestinal issues. Newer classes like gepants may have more favorable safety profiles for some patient populations.
• Market Segmentation: Treximet primarily targets moderate to severe migraine attacks where monotherapy with NSAIDs is insufficient.

What are the Future Projections for Treximet?

The future trajectory of branded Treximet is a significant decline in sales due to the established presence of generic competition and the continued innovation in migraine therapeutics.

• Continued Sales Decline: Branded Treximet sales are projected to continue their downward trend, likely falling into the low single-digit millions annually. The majority of the market share for sumatriptan/naproxen sodium combination will reside with generic manufacturers.
• Generic Market Stability: The generic sumatriptan/naproxen sodium market will likely remain competitive, with prices stabilizing at a low level, driven by volume and multiple suppliers.
• Therapeutic Shift: The ongoing development and adoption of CGRP antagonists (gepants) and other novel migraine therapies will further diminish the market share of older acute treatments like Treximet, especially for patients seeking alternative mechanisms or improved tolerability.
• Role in Treatment Guidelines: While Treximet may remain an option for specific patient profiles or in formulary contexts where cost is a primary driver, its prominence in acute migraine treatment guidelines is expected to decrease in favor of newer, potentially more effective or better-tolerated options.
• Potential for Repackaging or New Formulations (Unlikely): Given its age and the competitive landscape, significant investment in developing new formulations or repositioning Treximet is improbable.

Key Takeaways

• Treximet's primary U.S. patent expired on April 10, 2024, leading to widespread generic competition.
• Generic entry has caused a sharp decline in branded Treximet sales, from a peak of over $250 million annually to approximately $40 million in 2023.
• The acute migraine market is evolving with newer classes like gepants, which offer alternative mechanisms of action and may impact the long-term utility of older drugs like Treximet.
• Branded Treximet sales are projected to continue to decline significantly, with the market share dominated by generic versions.

Frequently Asked Questions

1. What is the primary mechanism of action for Treximet? Treximet combines sumatriptan, a selective serotonin 5-HT1B/1D receptor agonist, with naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan works by constricting cranial blood vessels and inhibiting the release of pro-inflammatory neuropeptides. Naproxen sodium reduces inflammation.

2. Are there other fixed-dose combinations of sumatriptan and naproxen available? Yes, other manufacturers have developed and marketed generic fixed-dose combination tablets of sumatriptan and naproxen sodium after the expiration of relevant patents.

3. What are the main side effects associated with Treximet? Common side effects include dizziness, drowsiness, tingling sensations, flushing, chest discomfort, and nausea. Like other triptans, it carries a risk of cardiovascular events. Naproxen sodium can cause gastrointestinal issues such as heartburn and stomach pain.

4. Who are the main competitors to Treximet in the acute migraine market? Competitors include other oral triptans (rizatriptan, zolmitriptan, etc.), other NSAIDs, and newer classes of acute migraine treatments such as gepants (ubrogepant, rimegepant) and ditans (lasmiditan). Generic versions of sumatriptan/naproxen are direct competitors.

5. What is the typical cost difference between branded Treximet and its generic alternatives? Generic versions of Treximet are substantially less expensive than the branded product, often costing 50-80% less, particularly after the initial period of generic market penetration.

Citations

[1] U.S. Patent No. 7,115,638. (2006). Pharmaceutical composition comprising a combination of a serotonin 5-HT1 receptor agonist and an anti-inflammatory agent. United States Patent and Trademark Office.

[2] GlaxoSmithKline. (Annual Reports 2016-2023). Form 20-F Filings. Securities and Exchange Commission.

[3] FDA Center for Drug Evaluation and Research. (2007). Application Number 021775, Supplemental Number 004. U.S. Food and Drug Administration.