Sumatriptan - Generic Drug Details

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

Sumatriptan is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Adaptis, Cipla, Lannett Co Inc, Padagis Israel, Tonix Meds, Meridian Medcl, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience Speclts, Sun Pharm, Teva Parenteral, Teva Pharms Usa, Wockhardt, Zydus, Currax, Teva Branded Pharm, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Vkt Pharma, and Watson Labs, and is included in forty-nine NDAs. There are thirty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan has one hundred and two patent family members in thirty-three countries.

There are twenty-four drug master file entries for sumatriptan. Ten suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for sumatriptan

International Patents:	102
US Patents:	39
Tradenames:	10
Applicants:	38
NDAs:	49
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	115
Patent Applications:	6,441
Drug Prices:	Drug price trends for sumatriptan
Drug Sales Revenues:	Drug sales revenues for sumatriptan
What excipients (inactive ingredients) are in sumatriptan?	sumatriptan excipients list
DailyMed Link:	sumatriptan at DailyMed

See drug prices for sumatriptan

See drug sales revenues for sumatriptan

Recent Clinical Trials for sumatriptan

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

Sponsor	Phase
Canisius-Wilhelmina Hospital	Phase 2
Leiden University Medical Center	Phase 2
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 2

See all sumatriptan clinical trials

Generic filers with tentative approvals for SUMATRIPTAN

Applicant	Application No.	Strength	Dosage Form
		EQ 100MG BASE	TABLET;ORAL
		EQ 50MG BASE	TABLET;ORAL
		EQ 25MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for sumatriptan

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Medical Subject Heading (MeSH) Categories for sumatriptan

Serotonin 5-HT1 Receptor Agonists

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for sumatriptan

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

US Patents and Regulatory Information for sumatriptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076554-002	Aug 10, 2009		DISCN	No	No
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No	9,427,578		Y
Eugia Pharma	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	202758-001	Apr 23, 2013	AP	RX	No	Yes
Sun Pharm Inds Ltd	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076572-001	Feb 9, 2009		DISCN	No	No
Dr Reddys	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	090495-001	Jan 29, 2014	AB	RX	No	No
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	7,975,690		Y

Expired US Patents for sumatriptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997	5,037,845*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997	5,307,953*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997	4,816,470*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997	4,816,470*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,554,639*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997	5,705,520*PED

EU/EMA Drug Approvals for sumatriptan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Galpharm Healthcare Ltd.	Sumatriptan Galpharm	sumatriptan	EMEA/H/C/002140	Refused	yes	no	no		2012-02-09

International Patents for sumatriptan

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3082817	COMPOSITIONS POUR ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION)
Mexico	2023002506	FORMULACIONES DE EPINEFRINA INTRANASAL Y METODOS PARA EL TRATAMIENTO DE ENFERMEDADES. (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE.)
Lithuania	3678649
Australia	2021254650	Intranasal epinephrine formulations and methods for the treatment of disease
South Korea	101646079
Russian Federation	2018107419	Композиции, содержащие триптановые соединения

Supplementary Protection Certificates for sumatriptan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649	C20250011	Finland
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822

Market Dynamics and Financial Trajectory for Sumatriptan Succinate

Introduction

Sumatriptan succinate, a widely used medication for the treatment of acute migraine, is experiencing significant growth and evolution in the global pharmaceutical market. Here, we delve into the market dynamics, financial trajectory, and key factors influencing the sumatriptan succinate market.

Global Market Size and Growth

The global sumatriptan succinate market is projected to be substantial, with a market size estimated at USD 2615.2 million in 2024. This market is expected to expand at a compound annual growth rate (CAGR) of 12.30% from 2024 to 2031[1].

Regional Market Analysis

North America

North America is a major market for sumatriptan succinate, accounting for over 40% of the global revenue with a market size of USD 1046.08 million in 2024. The region's robust healthcare infrastructure and stringent regulatory framework ensure product safety and efficacy, contributing to the market's growth at a CAGR of 10.5% from 2024 to 2031[1].

Europe

Europe holds a significant share of the global market, with a market size of USD 784.56 million in 2024. The European market is characterized by a well-developed healthcare system, extensive research capabilities, and a high prevalence of migraines. It is expected to grow at a CAGR of 10.8% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region is another key market, with a market size of USD 601.5 million in 2024. This region is expected to grow at a CAGR of 14.3% from 2024 to 2031, driven by the increasing prevalence of migraines, a growing population, and improving healthcare infrastructure[1].

South America and Middle East & Africa

South America and the Middle East & Africa also contribute to the global market, with market sizes of USD 130.76 million and USD 52.3 million in 2024, respectively. These regions are expected to grow at CAGRs of 11.7% and 12.0% from 2024 to 2031, although they face challenges such as disparities in healthcare access and economic constraints[1].

Market Drivers

Increasing Prevalence of Migraines

The rising incidence of migraines globally is a significant driver for the sumatriptan succinate market. As more people seek effective treatments for acute migraines, the demand for sumatriptan succinate is increasing[4].

Advancements in Healthcare and Technology

Advancements in healthcare technology, including improvements in injection technologies, packaging, and patient training for self-administration, are enhancing the market. These innovations make sumatriptan succinate more accessible and user-friendly[1].

Regulatory Frameworks

Stringent regulatory frameworks in regions like North America and Europe ensure the safety and efficacy of pharmaceuticals, fostering confidence in sumatriptan succinate among healthcare providers and patients[1].

Market Segmentation

Dosage Types

The market is segmented by dosage types, including 4 mg, 6 mg, and other formulations. These different dosages cater to various patient needs and preferences[4].

End-Users

The market is also segmented by end-users, including hospitals, clinics, and other healthcare settings. Drug stores are a key component, providing retail avenues for patients to access over-the-counter migraine relief medications[4].

Competitive Landscape

Key Players

Companies like Tonix Pharmaceuticals are playing a significant role in the market. Tonix acquired two marketed products, Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray), which are indicated for the treatment of acute migraine. This acquisition is part of Tonix's strategy to expand its expertise in CNS disorders and become a fully integrated pharmaceutical company[2].

Strategic Moves

Market players are adopting various strategies such as R&D investments, license agreements, partnerships, mergers and acquisitions, and collaborations to gain a robust footing in the market. These strategies help in driving innovation and expanding market reach[4].

Financial Performance and Investments

Revenue and Growth

The acquisition of Zembrace SymTouch and Tosymra by Tonix Pharmaceuticals is expected to contribute significantly to the company's revenue. The cost of this acquisition was $15 million, with additional investments in inventory and other adjustments[2].

Research and Development

Companies are investing heavily in research and development to advance their CNS product pipelines. For example, Tonix Pharmaceuticals incurred R&D expenses of approximately $22.0 million in the second quarter of 2023, reflecting their commitment to clinical development programs[2].

Funding and Capital Raising

To support their operations and expansion plans, companies like Tonix Pharmaceuticals are engaging in capital-raising activities. Tonix raised $7.0 million in gross proceeds through a public offering of its common stock subsequent to the end of the second quarter of 2023[2].

Cost-Effectiveness and Economic Benefits

Economic Analysis

Studies have shown that sumatriptan succinate is cost-effective and offers significant economic benefits. For instance, a study found that the initiation of sumatriptan resulted in net cost savings of $222,332 ($1249 per patient) and a benefit-to-cost ratio of $5.67 gained for each healthcare dollar spent[5].

Reduction in Disability Days

Sumatriptan succinate has been shown to reduce migraine-related disability days significantly, improving patients' ability to function at work and in nonwork activities. This reduction in disability days contributes to overall cost savings and improved productivity[5].

Key Takeaways

• The global sumatriptan succinate market is projected to grow significantly, driven by increasing migraine prevalence and advancements in healthcare.
• Regional markets, particularly North America, Europe, and Asia Pacific, are key contributors to the global market.
• Market segmentation by dosage types and end-users highlights the diverse needs and preferences of patients.
• Strategic acquisitions and R&D investments by key players are driving market growth.
• Sumatriptan succinate is cost-effective and offers substantial economic benefits by reducing migraine-related disability days.

FAQs

What is the projected global market size for sumatriptan succinate in 2024?

The global sumatriptan succinate market size is estimated to be USD 2615.2 million in 2024[1].

Which region has the largest share of the global sumatriptan succinate market?

North America holds the largest share, accounting for over 40% of the global revenue[1].

What are the key drivers of the sumatriptan succinate market?

Key drivers include the increasing prevalence of migraines, advancements in healthcare technology, and stringent regulatory frameworks[1][4].

Which companies are significant players in the sumatriptan succinate market?

Companies like Tonix Pharmaceuticals, with their acquisition of Zembrace SymTouch and Tosymra, are significant players in the market[2].

Is sumatriptan succinate cost-effective?

Yes, sumatriptan succinate has been shown to be cost-effective, resulting in net cost savings and a favorable benefit-to-cost ratio[5].

Sources

1. Cognitive Market Research: Sumatriptan Succinate Market Report 2024 (Global Edition)
2. Tonix Pharmaceuticals: Tonix Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Highlights
3. Frankf Hashnode: Sumatriptan Succinate Market Emerging Trends and Future
4. BioSpace: Injectable Sumatriptan Market Growth 2022-2028
5. PubMed: Cost-effectiveness and cost-benefit of sumatriptan in patients with acute migraine

Last updated: 2024-12-16