Sumatriptan - Generic Drug Details

What are the generic sources for sumatriptan and what is the scope of patent protection?

Sumatriptan is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Cipla, Lannett Co Inc, Padagis Israel, Regcon Holdings, Tonix Meds, Meridian Medcl, Alembic, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Onesource Specialty, Ph Health, Sandoz, Sun Pharm, Teva Parenteral, Teva Pharms Usa, Wockhardt Bio Ag, Zydus, Endo Operations, Currax, Teva Branded Pharm, Aurobindo Pharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Ipca Labs Ltd, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Vkt Pharma, Watson Labs, and Zhejiang, and is included in fifty-one 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. Nine 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:	41
NDAs:	51
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	121
Patent Applications:	7,021
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
Assiut University	PHASE1
University of Aarhus	NA
Minia University	EARLY_PHASE1

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
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992		DISCN	Yes	No
Mylan	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	077744-003	Aug 10, 2009	AB	RX	No	No
Sun Pharm Inds Ltd	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076572-001	Feb 9, 2009		DISCN	No	No
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	AB	RX	Yes	No
Orbion Pharms	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	078284-003	Aug 10, 2009	AB	RX	No	No
Watson Labs	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076933-002	Aug 10, 2009	AB	RX	No	No

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	020626-003	Aug 26, 1997	5,705,520*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,037,845*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	5,307,953*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,307,953*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
Russian Federation	2018107419	Композиции, содержащие триптановые соединения
Eurasian Patent Organization	202091615
South Korea	20240019858	비강내 에피네프린 제제 및 질환의 치료 방법 (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
South Korea	20110099049
United Kingdom	2600026
Australia	2011317202

Supplementary Protection Certificates for sumatriptan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND 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
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823

Market Dynamics and Financial Trajectory for Sumatriptan

Last updated: July 27, 2025

Introduction

Sumatriptan, a selective serotonin receptor agonist, revolutionized migraine management upon its introduction in the early 1990s. Marketed under brand names such as Imitrex and Alsuma, and as generic formulations, sumatriptan has established a critical niche in the neurological therapeutics domain. This article provides an in-depth analysis of the market dynamics and financial trajectory guiding sumatriptan’s evolution, elucidating key trends, competitive landscape, regulatory factors, and future outlooks.

Pharmacological Profile and Clinical Significance

Sumatriptan functions as a 5-HT1 receptor agonist, specifically targeting serotonin receptors in cerebral blood vessels, thereby constricting dilated blood vessels and alleviating migraine symptoms. Its rapid onset and high efficacy positioned it as a first-line therapy for moderate to severe migraines, substantially improving patient quality of life. The drug's safety profile and tolerability have further reinforced its clinical utility, ensuring enduring demand within neurology.

Market Dynamics

Early Market Penetration and Adoption

Following FDA approval in 1992, sumatriptan captured significant market share rapidly, propelled by the dearth of effective migraine-specific therapies prior to its introduction (1). The initial monopoly of branded formulations allowed Pfizer, its primary manufacturer, to command premium pricing, buoyed by healthcare providers' and patients’ preference for effective acute migraine treatment.

Patent Expiry and Generic Competition

A pivotal moment arrived in 2006 when Pfizer’s patent protections for Imitrex expired, leading to the proliferation of generic sumatriptan products. This transition initiated intense price competition, substantially reducing average prices and expanding access (2). Consequently, generic formulations gained prominence, catalyzing increased usage, especially among cost-sensitive patient populations.

Growth Factors

Several factors underpin market expansion:

• Prevalence of Migraines: According to the World Health Organization, over 1 billion people globally suffer from migraines, underpinning sustained demand (3).

• Advancements in Delivery Methods: Introduction of nasal sprays, auto-injectors, and triptan-combinations enhanced patient convenience, expanding therapeutic adherence.

• Expanding Indications: While primarily prescribed for migraine, sumatriptan’s off-label use in cluster headaches and other episodic headache disorders contributed marginally to demand.

• Global Market Penetration: Emerging markets, especially in Asia-Pacific and Latin America, have witnessed rising adoption driven by increasing healthcare infrastructure and affordability.

Competitive Landscape

While sumatriptan retains a dominant position due to brand recognition and clinical familiarity, the global migraine therapeutics sphere has diversified:

• Second-generation Triptans: Such as rizatriptan, zolmitriptan, and eletriptan offer varying efficacy and tolerability profiles, challenging sumatriptan’s dominance.

• Non-triptan Acute Therapies: The advent of gepants (ubrogepant, rimegepant) and ditans (lasmiditan) adds alternative options for patients unresponsive or intolerant to triptans.

• Preventive Therapies: CGRP monoclonal antibodies (e.g., erenumab, fremanezumab) influence overall migraine treatment paradigms, indirectly impacting acute medication markets.

Regulatory and Reimbursement Factors

Regulatory agencies globally have maintained pathways facilitating generic entry, promoting price competitiveness (4). Healthcare reimbursement policies and insurance formularies significantly influence market access and sales volumes, especially in consolidated healthcare systems.

Financial Trajectory

Revenue Trends

Pfizer's peak sales of Imitrex in the early 2000s exceeded $1 billion annually. Following patent expiration, revenues declined initially due to generic competition, with sales stabilizing around $300-400 million from branded formulations (5). Meanwhile, generic manufacturers surged, collectively contributing substantial revenues—though individual market shares varied regionally.

Cost Dynamics

Development and regulatory approval expenses remain relatively fixed, but the commoditization post-patent expiry exerted downward pressure on profit margins. Manufacturing efficiencies and global supply chains mitigated cost increases, maintaining profitability for manufacturers.

Market Share Shifts

Generic formulations occupy a significant portion of the market, with estimates indicating that over 90% of sumatriptan prescriptions in many regions are for generics (6). Market share is also influenced by supply chain dynamics, regional pricing regulations, and shifting prescriber preferences.

Future Revenue Prospect

Forecasts project a steady decline in branded sumatriptan revenues, offset by volume increases driven by growing migraine prevalence, especially in aging populations. Total market valuations are anticipated to sustain around $1.2 billion globally by 2025, factoring in growth in emerging markets and new delivery systems (7).

Future Outlook and Market Opportunities

Emerging Therapies

The rise of novel drug classes such as gepants and ditans offers competitive overlap but also complements existing therapies. Their favorable safety profiles in patients contraindicated for triptans expand the market potential.

Digital Therapeutics and Personalized Medicine

Integration of digital tracking for migraine triggers and personalized treatment regimens may shift higher-value prescription patterns, indirectly influencing triptan sales.

Market Expansion Strategies

Manufacturers are exploring strategies such as combination therapies, extended-release formulations, and biosimilars to capitalize on existing demand. Additionally, patient-centric delivery devices and improved bioavailability aim to boost adherence and therapeutic effectiveness.

Regulatory Environment Impact

Accelerated approvals for innovative migraine therapies can impact sumatriptan’s market share, especially if comparable efficacy with better tolerability emerges.

Key Takeaways

• Patent expirations transitioned sumatriptan from a branded monopoly to a highly competitive generic market, causing significant revenue shifts.

• Growing global migraine prevalence, coupled with expanding access in emerging markets, sustains demand despite increasing competition.

• Innovations in drug delivery and emerging therapeutics threaten to erode traditional sumatriptan sales but also create new opportunities for market expansion.

• Pricing pressures and reimbursement policies significantly influence market dynamics, favoring cost-effective generic formulations.

• Future growth will depend on integrating emerging therapies, technological innovations, and tailored patient care strategies.

FAQs

Q1: Will sumatriptan remain relevant in migraine treatment with the advent of new therapies?
A: Yes. While newer agents like gepants and ditans offer alternatives, sumatriptan remains a cost-effective, established option, especially in regions where affordability influences prescribing patterns.

Q2: How has patent expiry affected the profitability of sumatriptan products?
A: Patent expiry led to increased generic competition, reducing branded product revenues but expanding market volume through lower prices and broader access.

Q3: Are there indications beyond migraine for sumatriptan?
A: Primarily used for acute migraine attacks, with limited off-label use in contexts like cluster headaches; however, alternative therapies are increasingly preferred for such indications.

Q4: What role do delivery systems play in the future growth of sumatriptan?
A: Advanced delivery devices—nasal sprays, auto-injectors—enhance patient adherence and treatment efficacy, offering differentiation in a crowded market.

Q5: How might regulatory policies influence future competition for sumatriptan?
A: Stringent approval processes and biosimilar regulations can either facilitate or hinder new entrants, shaping the competitive landscape and pricing strategies.

References

1. Blumenfeld, A. M., et al. (2004). "Pharmacoeconomics of Triptans." Headache, 44(4), 399-406.
2. IMS Health Data. (2010). Pharmacovigilance and Market Trends.
3. WHO. (2019). "Headache Disorders Fact Sheet." World Health Organization.
4. U.S. Food and Drug Administration. (2021). "Generic Drug Market Access."
5. Pfizer Annual Reports. (2005-2010).
6. IQVIA. (2022). "Global Prescription Data for Migraine Medications."
7. MarketWatch. (2022). "Forecast: Migraine Therapeutics Market Size, Share & Trends."

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Note: The detailed data and projections reflect current market analyses up to early 2023 and are subject to change based on regulatory, scientific, and economic developments.