NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - Generic Drug Details

What are the generic sources for naproxen sodium; sumatriptan succinate and what is the scope of freedom to operate?

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
The Second Hospital of Nanjing Medical University	Phase 3
The Affiliated Hospital of Qingdao University	Phase 3
Jiangsu Provincial People's Hospital	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
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
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
Rising	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	090872-001	Sep 4, 2018	AB	RX	No	No

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

International Patents for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Country	Patent Number	Title	Estimated Expiration
Mexico	PA05006954	FORMAS DE DOSIFICACION DE CAPAS MULTIPLES QUE CONTIENEN NSAIDS Y TRIPTANOS. (Multilayer Dosage Forms Containing NSAIDs and Triptans.)
Japan	4616009
Canada	2509023	FORMES GALENIQUES MULTICOUCHES CONTENANT DES AINS ET DES TRIPTANES (MULTILAYER DOSAGE FORMS CONTAINING NSAIDS AND TRIPTANS)
World Intellectual Property Organization (WIPO)	2004060355
Japan	2006515856

Supplementary Protection Certificates for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	122012000051	Germany		PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naproxen Sodium and Sumatriptan Succinate

Introduction to Naproxen Sodium and Sumatriptan Succinate

Naproxen sodium and sumatriptan succinate are two widely used pharmaceuticals with distinct therapeutic applications. Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) primarily used for pain relief, including arthritis, muscle strain, and back pain. Sumatriptan succinate, on the other hand, is a selective serotonin receptor agonist used for the treatment of migraines.

Market Dynamics of Naproxen Sodium

Availability and Dosing

Naproxen sodium is available both as a prescription and over-the-counter (OTC) drug. In the U.S., it is marketed by companies like Genetech (a member of the Roche group) and Bayer AG. The approved dosing for naproxen sodium is a single dose of 220-440 mg, with a dosing interval of every 8 to 12 hours, and a maximum daily dose limit of 600 mg[1].

Market Drivers

The naproxen sodium market is driven by several key factors:

• Non-Prescription Availability: Its availability as an OTC drug makes it easily accessible to consumers, contributing to its market growth.
• Established Benefits and Risks: The well-documented benefits and risks of naproxen sodium enhance consumer confidence and healthcare provider trust.
• Geriatric Population: The increasing geriatric population and the associated rise in arthritis cases boost the demand for naproxen sodium.
• Diverse Pain Relief Uses: Naproxen sodium is used for various pain conditions, including muscle strain, back pain, and knee pain, further expanding its market[1].

Market Restraints

Despite its growth drivers, the naproxen sodium market faces several restraints:

• Cardiovascular Risks: Increased risk of cardiovascular events such as heart attacks and strokes, especially in older populations.
• Gastrointestinal Risks: Risks of abdominal bleeding or ulcers.
• Allergic Reactions: Potential for allergic reactions, particularly in older individuals[1].

Financial Trajectory of Naproxen Sodium

The financial trajectory of naproxen sodium is influenced by its widespread use and availability:

• Market Size: The global non-steroidal anti-inflammatory drugs (NSAIDs) market, which includes naproxen sodium, was valued at USD 19,551.54 million in 2021 and is expected to reach USD 31.45 billion by 2030, growing at a CAGR of 5.42% from 2022 to 2030[4].
• Distribution Channels: Retail pharmacies hold the largest market share, with hospital pharmacies and online pharmacies also contributing significantly to the sales of naproxen sodium[4].

Market Dynamics of Sumatriptan Succinate

Therapeutic Use

Sumatriptan succinate is specifically used for the acute treatment of migraine attacks. It is available in various formulations, including tablets and subcutaneous injections.

Market Drivers

The sumatriptan succinate market is driven by:

• Aging Population: The increasing prevalence of migraines among the aging population.
• Technological Advancements: Improvements in healthcare infrastructure and advancements in injection technologies.
• Regulatory Framework: Strict regulatory frameworks ensuring product safety and efficacy, particularly in regions like North America and Europe[2].

Market Segments

The market is segmented into various regions and formulations:

• North America: This region holds more than 40% of the global revenue, with a market size of USD 1046.08 million in 2024, expected to grow at a CAGR of 10.5% from 2024 to 2031[2].
• Europe: Accounts for over 30% of the global market size, with a robust healthcare infrastructure and extensive research capabilities[2].
• Asia Pacific: Holds around 23% of the global revenue, with a CAGR of 14.3% from 2024 to 2031, driven by the increasing prevalence of migraines and improving healthcare infrastructure[2].

Market Restraints

Despite the growth drivers, the sumatriptan succinate market faces challenges:

• Regulatory Variations: Different regulatory frameworks across countries impact market dynamics.
• Economic Constraints: Disparities in healthcare access and economic constraints affecting patient affordability, particularly in regions like Latin America and the Middle East & Africa[2].

Financial Trajectory of Sumatriptan Succinate

The financial outlook for sumatriptan succinate is promising:

• Global Market Size: The global sumatriptan succinate market size was estimated at USD 2615.2 million in 2024, expected to expand at a CAGR of 10.8% from 2024 to 2031[2].
• Regional Growth: North America, Europe, and Asia Pacific are key regions driving the market growth, with Latin America and the Middle East & Africa also presenting opportunities despite challenges[2].

Key Players and Strategies

Both markets are influenced by the strategies of key players:

• Naproxen Sodium: Companies like Bayer AG and Genetech focus on geographical expansion and the introduction of combination NSAIDs to increase market share[4].
• Sumatriptan Succinate: Stakeholders must adapt to evolving healthcare systems, focus on regulatory compliance, and engage in market access strategies and collaborations to navigate challenges and leverage opportunities[2].

Distribution Channels

The distribution channels for both drugs play a crucial role in their market dynamics:

• Naproxen Sodium: Retail pharmacies hold the largest market share, followed by hospital pharmacies, with online pharmacies expected to grow rapidly[4].
• Sumatriptan Succinate: Drug stores, including chain and independent pharmacies, are key components, along with hospital pharmacies providing timely access to the medication[2].

Consumer Insights

Consumer behavior and preferences significantly impact the market:

• Naproxen Sodium: The ease of access to OTC naproxen sodium and its widespread use for various pain conditions make it a preferred choice for many consumers[1].
• Sumatriptan Succinate: The increasing awareness of migraine management and the availability of sumatriptan succinate in various formulations cater to different patient needs and preferences[2].

Regulatory Environment

The regulatory environment is a critical factor in both markets:

• Naproxen Sodium: Regulatory approvals for OTC drugs and the safety and efficacy profiling of naproxen sodium support its market growth[1].
• Sumatriptan Succinate: Strict regulatory frameworks in regions like North America and Europe ensure product safety and efficacy, fostering consumer confidence[2].

Technological Advancements

Technological advancements influence the market dynamics of both drugs:

• Naproxen Sodium: Improvements in formulation and delivery systems, such as topical NSAIDs, are expected to drive growth[4].
• Sumatriptan Succinate: Advancements in injection technologies and packaging contribute to the growth of the subcutaneous injection segment[2].

Future Outlook

The future outlook for both drugs is positive but comes with challenges:

• Naproxen Sodium: Expected to grow at a CAGR of 5.42% from 2022 to 2030, driven by increasing chronic pain and arthritis prevalence[4].
• Sumatriptan Succinate: Projected to grow at a CAGR of 10.8% from 2024 to 2031, driven by the aging population and technological advancements[2].

"Continuous adaptation to evolving healthcare systems and cultural considerations will be crucial for success in this dynamic and diverse regional landscape."[2]

Key Takeaways

• Naproxen Sodium:

  • Driven by non-prescription availability, established benefits and risks, and an increasing geriatric population.
  • Faces restraints such as cardiovascular and gastrointestinal risks.
  • Expected to grow at a CAGR of 5.42% from 2022 to 2030.

• Sumatriptan Succinate:

  • Driven by the aging population, technological advancements, and strict regulatory frameworks.
  • Faces challenges such as regulatory variations and economic constraints.
  • Expected to grow at a CAGR of 10.8% from 2024 to 2031.

FAQs

What are the primary drivers of the naproxen sodium market?

The primary drivers include its availability as a non-prescription drug, well-established profiling of its benefits and risks, and the increasing geriatric population.

How does the regulatory environment impact the sumatriptan succinate market?

The regulatory environment ensures product safety and efficacy, particularly in regions like North America and Europe, fostering consumer confidence and driving market growth.

What are the key distribution channels for naproxen sodium and sumatriptan succinate?

For naproxen sodium, retail pharmacies hold the largest market share, followed by hospital pharmacies and online pharmacies. For sumatriptan succinate, drug stores and hospital pharmacies are key components.

What are the projected growth rates for the naproxen sodium and sumatriptan succinate markets?

The naproxen sodium market is expected to grow at a CAGR of 5.42% from 2022 to 2030, while the sumatriptan succinate market is projected to grow at a CAGR of 10.8% from 2024 to 2031.

How do technological advancements influence the markets for these drugs?

Technological advancements in formulation and delivery systems for naproxen sodium, and improvements in injection technologies and packaging for sumatriptan succinate, contribute to market growth and patient satisfaction.

Sources

1. Transparency Market Research - Naproxen Market Insight and Trends 2024
2. Cognitive Market Research - Sumatriptan Succinate Market Report 2024 (Global Edition)
3. GSK Annual Report 2008
4. Biospace - Non-steroidal Anti-inflammatory Drugs Market Size USD 31.45 Billion by 2030
5. Dataintelo - Sumatriptan Succinate Market Research Report 2032