Naproxen sodium; sumatriptan succinate - Generic Drug Details

What are the generic drug sources for naproxen sodium; sumatriptan succinate and what is the scope of patent protection?

Naproxen sodium; sumatriptan succinate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Rising, Sun Pharm, and Currax, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Naproxen sodium; sumatriptan succinate has sixteen patent family members in fourteen countries.

Five suppliers are listed for this compound.

Summary for naproxen sodium; sumatriptan succinate

International Patents:	16
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	5
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naproxen sodium; sumatriptan succinate
DailyMed Link:	naproxen sodium; sumatriptan succinate at DailyMed

Recent Clinical Trials for naproxen sodium; sumatriptan succinate

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

Sponsor	Phase
Second Hospital of Jilin University	Phase 3
Beijing Friendship Hospital	Phase 3
The Third Xiangya Hospital of Central South University	Phase 3

See all naproxen sodium; sumatriptan succinate clinical trials

Pharmacology for naproxen sodium; sumatriptan succinate

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

Anatomical Therapeutic Chemical (ATC) Classes for naproxen sodium; sumatriptan succinate

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

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 naproxen sodium; sumatriptan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	207457-001	Feb 15, 2018	AB	RX	No	No
Sun Pharm	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	202803-001	Jul 20, 2018	AB	RX	No	No
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes					Y
Rising	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	090872-001	Sep 4, 2018	AB	RX	No	No
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No					Y

Expired US Patents for naproxen sodium; sumatriptan succinate

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

Country	Patent Number	Title	Estimated Expiration
Japan	2006515856
Mexico	PA05006954	FORMAS DE DOSIFICACION DE CAPAS MULTIPLES QUE CONTIENEN NSAIDS Y TRIPTANOS. (Multilayer Dosage Forms Containing NSAIDs and Triptans.)
Spain	2380827
European Patent Office	1575566	FORMES GALENIQUES MULTICOUCHES CONTENANT DE NAPROXENE ET DES TRIPTANES (MULTILAYER DOSAGE FORMS CONTAINING NAPROXEN AND TRIPTANS)
Austria	546134
Norway	336458

Supplementary Protection Certificates for naproxen sodium; sumatriptan succinate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	18/2011	Austria		PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
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	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105

Market Dynamics and Financial Trajectory for Naproxen Sodium and Sumatriptan Succinate

Last updated: July 28, 2025

Introduction

Naproxen sodium and sumatriptan succinate are pivotal in the pharmaceutical landscape, serving distinct therapeutic purposes. Naproxen sodium, an over-the-counter (OTC) non-steroidal anti-inflammatory drug (NSAID), primarily addresses pain, inflammation, and fever. Conversely, sumatriptan succinate, a prescription serotonin receptor agonist, is a cornerstone in acute migraine management. Understanding their market dynamics and financial trajectories provides insight into their evolving roles, competitive positioning, and investment potential.

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Market Overview of Naproxen Sodium

Historical and Current Market Landscape

Naproxen sodium enjoys a robust market owing to its widespread OTC availability, established efficacy, and safety profile. The global NSAID market was valued at approximately $15 billion in 2022, with naproxen maintaining a significant share, largely driven by OTC sales in North America and Europe. Its versatility addresses arthritis, menstrual pain, and general inflammatory conditions, fueling consistent demand.

The OTC segment dominates, representing over 60% of the NSAID market volume. This position secures steady revenue streams, with key players like Bayer, Johnson & Johnson, and Teva holding considerable market shares [1]. The rising prevalence of chronic inflammatory conditions and an aging population bolster long-term demand.

Regulatory and Patent Landscape

While naproxen sodium primarily faces patent expiration—most formulations have been off-patent for over a decade—market resilience stems from generic competition, price competition, and formulation innovations. Recent regulatory scrutiny on NSAID safety profiles, especially concerning cardiovascular risks, influences prescribing practices and consumer confidence.

Innovation and New Formulations

Developments in formulation, such as sustained-release tablets, aim to improve compliance and efficacy. The emergence of combination OTC products enhances market reach, although patent hurdles limit exclusivity for new formulations.

Market Challenges

Potential risks include safety concerns, which may prompt regulatory restrictions or label updates, affecting sales. Additionally, competition from alternative analgesics—acetaminophen, COX-2 inhibitors—and rising consumer preference shifts toward natural remedies can erode market share.

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Financial Trajectory for Naproxen Sodium

Revenue Streams and Growth Drivers

The OTC nature ensures consistent revenue, especially as demographic trends favor increased usage. The generic market amplifies volume sales but constrains profit margins. Market forecasts project a compound annual growth rate (CAGR) of approximately 1.5-2% over the next five years, driven by aging populations and heightened chronic pain awareness [2].

Impact of Regulatory and Safety Trends

Enhanced safety monitoring may influence formulations or usage recommendations, with potential marginal impacts on sales. Companies investing in novel, safer formulations could establish premium segments, slightly boosting revenue.

Market Entry and Competition

Barriers to entry remain significant, but companies innovating in delivery mechanisms or targeting niche markets (e.g., formulations for specific populations) may capture additional market share. Price competition remains fierce, compressing margins.

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Market Overview of Sumatriptan Succinate

Global and Regional Market Footprint

Sumatriptan succinate, a selective serotonin receptor agonist, predominantly addresses acute migraine episodes. The global antimigraine therapeutics market was valued at approximately $4.2 billion in 2022, with sumatriptan accounting for around 45% of prescription sales [3].

North America remains the dominant market, driven by high migraine prevalence, advanced healthcare infrastructure, and insurance coverage. Europe and Asia-Pacific are expanding, propelled by increasing awareness, expanding reimbursement, and rising migraine incidence.

Formulation Innovations and Delivery Platforms

Initially launched as an injectable, sumatriptan is now available in oral tablets, nasal sprays, and autoinjectors. Innovations aim to improve ease of use, treatment adherence, and onset of action. The advent of Nasal Sprays and Autoinjectors enhances patient convenience, expanding market penetration.

Regulatory Environment

Stringent approval processes and patent protections influence product lifecycle. Recently, the launch of new formulations like Zecuity (transdermal patch) and liquid nasal spray formulations indicate continuous innovation, extending market reach.

Competitive Landscape

Major players include Novartis, Teva, and GlaxoSmithKline, fighting for market share through formulation differentiation, marketing, and reimbursement strategies. Patent expirations of early formulations have triggered a surge in generics, intensifying price competition.

Market Challenges

Safety concerns—such as cardiovascular risks associated with triptans—necessitate careful patient selection, influencing prescribing trends. Additionally, emergence of CGRP (calcitonin gene-related peptide) inhibitors as prophylactic options is reshaping the migraine treatment landscape, potentially impacting sumatriptan sales.

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Financial Trajectory for Sumatriptan Succinate

Revenue Trends and Forecasts

Despite intense competition, sumatriptan maintains a stable revenue base, with estimated global sales exceeding $2 billion annually. The introduction of new delivery devices and formulations sustains growth, with projections estimating a CAGR of 2-3% over the next five years [4].

Market Expansion Opportunities

Emerging markets—such as Asia-Pacific and Latin America—present significant expansion opportunities. Increasing healthcare access and awareness are catalysts, although cost and reimbursement constraints may influence adoption.

Impact of Competition from CGRP Inhibitors

Prophylactic agents like erenumab and fremanezumab have entered the market, provided substantial alternatives for chronic migraine patients. While triptans are primarily acute treatments, the shift toward preventive therapy could modulate overall demand.

Patent and Regulatory Risks

Patent cliff effects have increased generic availability, compressing prices and margins. Companies investing in delivery innovations or combination therapies could counteract decline pressures.

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Key Market Drivers and Trends

• Aging Population: Both drugs serve conditions predominantly affecting older demographics, reinforcing steady demand.

• Consumer Preferences: Growing preference for OTC medications favors naproxen sodium, while the demand for user-friendly sumatriptan delivery systems supports continued innovation.

• Regulatory Environment: Evolving safety profiles and regulatory scrutiny influence formulation and marketing strategies.

• Competitive Innovation: Custom delivery devices, combination products, and formulation improvements underpin competitive differentiation and market shares.

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Conclusion: Strategic Insights

The markets for naproxen sodium and sumatriptan succinate remain robust, driven by demographic trends, innovation, and established roles in pain and migraine management. However, both face competitive pressures from generics, safety regulations, and emerging therapies, necessitating continuous innovation, targeted marketing, and strategic adaptation.

Investors and pharmaceutical companies should monitor regulatory updates, safety profiles, and technological advancements in drug delivery to optimize product lifecycle and revenue potential. Focused investment in formulations that address safety concerns, improve adherence, and expand into emerging markets will be crucial in shaping their future financial trajectories.

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Key Takeaways

• Naproxen sodium benefits from OTC status and broad indications but faces price competition, safety concerns, and regulatory scrutiny, positioning it as a steady, if modest, growth asset.

• Sumatriptan succinate maintains a leading position in acute migraine treatment, with value derived from innovative delivery systems; however, competition from CGRP inhibitors and generic erosion pressures demand strategic innovation.

• Innovation in formulation and delivery remains a critical driver, especially in extending patent life and expanding patient adherence.

• Emerging markets represent significant growth opportunities for both drugs, provided reimbursement and regulatory barriers are navigated.

• Safety profiles and regulatory oversight will increasingly influence market stability, requiring pharmaceutical companies to prioritize safety in product development and marketing strategies.

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FAQs

1. How does patent expiration impact the market for naproxen sodium?
Patent expiration leads to increased generic competition, reducing prices and profit margins. Companies focus on formulation innovations and branding to maintain market share.

2. What are the primary factors influencing sumatriptan’s sales growth?
Innovations in delivery devices, expanding formulations, and emerging migraine therapies influence sales. Safety concerns and competition from newer prophylactic treatments also impact growth.

3. Are there upcoming regulatory challenges for these drugs?
Yes. Safety concerns, especially regarding cardiovascular risks in NSAIDs and triptans, can lead to stricter labeling or restrictions, affecting market dynamics.

4. How significant is the role of emerging markets for these drugs?
Emerging markets offer growth opportunities due to increasing healthcare infrastructure and awareness, but reimbursement and regulatory hurdles must be addressed.

5. Will new therapies replace naproxen sodium and sumatriptan in the future?
Emerging therapies, especially CGRP inhibitors, are supplementing existing treatments, primarily in migraine prophylaxis, but NSAIDs and triptans remain core treatments due to established efficacy and familiarity.

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Sources

[1] MarketWatch, "NSAID Market Share Analysis," 2022.
[2] Grand View Research, "NSAID Market Size & Trends," 2022.
[3] IQVIA, "Global Migraine Market Report," 2022.
[4] Evaluate Pharma, "Sumatriptan Market Forecast," 2022.