IMITREX Drug Patent Profile

When do Imitrex patents expire, and what generic alternatives are available?

Imitrex is a drug marketed by Glaxosmithkline and is included in three NDAs.

The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imitrex

A generic version of IMITREX was approved as sumatriptan by LANNETT CO INC on February 19^th, 2016.

Summary for IMITREX

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	23
Patent Applications:	4,180
Drug Prices:	Drug price information for IMITREX
Drug Sales Revenues:	Drug sales revenues for IMITREX
What excipients (inactive ingredients) are in IMITREX?	IMITREX excipients list
DailyMed Link:	IMITREX at DailyMed

See drug prices for IMITREX

See drug sales revenues for IMITREX

Recent Clinical Trials for IMITREX

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

Sponsor	Phase
Kimberly-Clark Corporation	Phase 1
Eli Lilly and Company	Phase 1
SNBL Clinical Pharmacology Center, Inc.	Phase 1

See all IMITREX clinical trials

Pharmacology for IMITREX

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

US Patents and Regulatory Information for IMITREX

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
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-001	Jun 1, 1995	AB	RX	Yes	Yes
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	AB	RX	Yes	Yes
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006	AB	RX	Yes	Yes
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997	AB	RX	Yes	Yes

Expired US Patents for IMITREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	5,037,845*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,705,520*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997	5,705,520*PED
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	6,020,001*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,307,953*PED

EU/EMA Drug Approvals for IMITREX

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 IMITREX

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2251614	Indole derivatives
Taiwan	205035
Spain	8609247
Italy	8548435
Switzerland	684242	Compositions pour l'administration buccale.

Market Dynamics and Financial Trajectory for IMITREX (Sumatriptan)

Last updated: July 30, 2025

Introduction

IMITREX, the brand name for Sumatriptan, remains a cornerstone in the management of acute migraine attacks. Approved by the FDA in 1992, IMITREX has maintained its relevance through continuous innovation, shifting competition, and evolving healthcare landscapes. This analysis explores the market dynamics influencing IMITREX’s positioning, evaluates its financial trajectory, and forecasts future industry trends impacting its commercial prospects.

Market Dynamics

Growing Prevalence of Migraine Disorders

Migraine affects approximately 12% of the global population, with higher prevalence among women aged 18-44 [1]. The increasing burden of migraine-related disability elevates the demand for effective acute treatments such as IMITREX. The World Health Organization classifies severe migraine as a disabling neurological disorder, driving both clinical and economic incentives for effective therapies.

Competitive Landscape and Therapeutic Alternatives

While IMITREX remains a dominant triptan, the market has diversified with the advent of new pharmacotherapies. The introduction of gepants (e.g., ubrogepant, rimegepant) and ditans (e.g., lasmiditan) has expanded treatment options, offering alternatives with potentially fewer cardiovascular contraindications. However, IMITREX retains a stronghold due to its established efficacy, familiarity among clinicians, and cost-effectiveness. Patent expirations and the emergence of generic equivalents limit potential premium pricing and influence revenue streams.

Regulatory and Reimbursement Environment

Reimbursement policies significantly impact IMITREX’s market access. Insurance coverage varies across regions, with some countries favoring generics to reduce costs. Additionally, regulatory scrutiny regarding cardiovascular safety has led companies to develop newer agents with improved safety profiles, partially constraining IMITREX’s growth prospects but also reinforcing its clinical utility for certain patient populations.

Innovations and Formulation Development

AbbVie, the current manufacturer, has pursued innovative formulations of sumatriptan—such as nasal sprays and auto-injectors—to enhance onset speed and patient compliance. These advancements help sustain market relevance amid competitive pressures. Moreover, combination therapies and digital health integrations represent emerging trends that could influence prescribing behaviors.

Market Penetration and Geographic Expansion

Regionally, North America remains the largest market, accounting for over 50% of revenue, driven by high migraine prevalence, advanced healthcare infrastructure, and aggressive marketing. Europe and Asia-Pacific offer growth opportunities, with rising awareness and improving healthcare access. However, differing regulatory pathways and pricing strategies present challenges to expansion.

Financial Trajectory

Revenue Trends

Earlier years saw IMITREX generating peak revenues of approximately $1.2 billion annually. Post patent expiry in the early 2000s, revenue decline was observed due to the entry of generic competitors, with estimates indicating a 40-50% reduction in US sales within a decade [2]. Despite this, branded IMITREX continues to generate substantial revenue, courtesy of its brand loyalty, physician familiarity, and formulation innovations.

Profitability and Market Share

While the entry of generics diminished gross margins, premium formulations and expanded indications sustained profitability. Moreover, the safety profile positions IMITREX as a preferred option for specific patient subsets, preserving niche market share. Strategic partnerships and direct-to-consumer advertising have contributed additionally to sales maintenance and growth in select segments.

Future Profitability Outlook

Forecasts suggest a gradual stabilization of revenues, aided by new delivery devices and targeted marketing campaigns. The global migraine therapeutics market is projected to reach USD 10 billion by 2027, with the triptan segment holding a significant share owing to its longstanding clinical efficacy [3]. IMITREX’s parent company, AbbVie, and potential biosimilar entrants will influence long-term financial outcomes.

Industry Trends Affecting Financial Trajectory

• Shift Toward Personalized Medicine: Genetic and biomarker research may enable tailored therapies, potentially reducing IMITREX’s relative market share.
• Digital and Telemedicine Adoption: Remote consultations and mobile health apps facilitate migraine management but may favor newer platforms with digital integrations over traditional formulations.
• Pricing Pressures and Cost-Containment: Healthcare systems increasingly prioritize cost-efficiency, exerting downward pressure on drug prices and affecting revenue growth.

Strategic Implications

To sustain financial viability, stakeholders should prioritize innovation in delivery systems, enhance digital engagement, and explore strategic collaborations. Diversifying indications and expanding into emerging markets can also buffer against generic erosion and competitive threats.

Conclusion

The market dynamics for IMITREX are characterized by a mature product facing intense competition and regulatory challenges yet still retaining meaningful revenue streams through innovation and geographic expansion. Its financial trajectory is expected to stabilize, influenced by industry trends, formulation advancements, and market access strategies.

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Key Takeaways

• The global migraine market continues to grow, supporting demand for effective agents like IMITREX despite newer alternatives.
• Patent expirations and generic entry have reduced revenues, but innovative formulations and strong brand loyalty sustain profitability.
• Industry trends toward digital health and personalized medicine will shape future market share and revenue potential.
• Strategic diversification and geographic expansion are critical for long-term financial resilience.
• Stakeholders must balance innovation, cost management, and market access to optimize IMITREX’s financial trajectory.

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FAQs

1. How has the patent expiration affected IMITREX’s market share?
Patent expirations in the early 2000s led to significant generic competition, reducing US sales by nearly half. Nevertheless, brand loyalty, formulation innovations, and targeted marketing have helped preserve a segment of its revenues.

2. What are the main competitors to IMITREX in the migraine treatment market?
Emerging classes like gepants (e.g., ubrogepant, rimegepant) and ditans (e.g., lasmiditan) are key competitors, offering alternatives with potentially safer cardiovascular profiles. Traditional triptans like eletriptan and sumatriptan remain primary options.

3. Can IMITREX capitalize on emerging markets?
Yes. Increasing healthcare access in Asia-Pacific and Latin America presents growth opportunities, although regulatory hurdles and pricing strategies can be challenging.

4. How do formulation innovations impact IMITREX’s market position?
Enhanced formulations, such as nasal sprays and auto-injectors, improve onset speed and patient convenience. These innovations support brand differentiation and adherence, helping retain market share.

5. What future industry trends could influence IMITREX’s profitability?
The shift toward personalized medicine, integration of digital health tools, and healthcare cost containment measures will impact its market share and revenue potential. Continuous innovation and strategic adaptation are vital.

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References

[1] Global Burden of Disease Study 2019. Lancet Neurol. 2020.
[2] IMS Health Data, 2010-2020.
[3] MarketWatch, "Migraine Therapeutics Market Forecast 2022-2027," 2022.