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. Ten 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:	184
Clinical Trials:	23
Patent Applications:	5,711
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

Expired US Patents for IMITREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	6,368,627*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	4,816,470*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
Canada	2105180	COMPOSITIONS CONTENANT DU SUMATRIPTAN (COMPOSITIONS CONTAINING SUMATRIPTAN)
United Kingdom	8419550
Slovakia	354092	DOSING APPARATUS

IMITREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Imitrex (Sumatriptan Succinate)

Introduction

Imitrex, generically known as sumatriptan succinate, is a groundbreaking medication in the treatment of migraines. Since its introduction, it has revolutionized the management of migraine headaches and continues to be a significant player in the pharmaceutical market.

Historical Context and Impact

Imitrex, developed by Glaxo Wellcome (now part of GlaxoSmithKline), was the first serotonin (5-HT) agonist designed to combat migraines. Its launch in the 1990s marked a significant milestone in migraine treatment, with sales reaching $840 million worldwide in 1996 alone[4].

Global Market Size and Growth

As of 2024, the global sumatriptan succinate market is estimated to be valued at USD 2615.2 million. This market is projected 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 the largest market for sumatriptan succinate, accounting for more than 40% of the global revenue, with a market size of USD 1046.08 million in 2024. The region's robust healthcare infrastructure, stringent regulatory framework, and high prevalence of migraines contribute to its dominance. The market here is expected to grow at a CAGR of 10.5% from 2024 to 2031[1].

Europe

Europe holds over 30% of the global market share, with a market size of USD 784.56 million in 2024. The region's well-developed healthcare infrastructure and extensive research capabilities drive the demand for sumatriptan succinate. The market in Europe is anticipated to grow at a CAGR of 10.8% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region accounts for around 23% of the global revenue, with a market size of USD 601.50 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].

Latin America

Latin America contributes more than 5% to the global revenue, with a market size of USD 130.76 million in 2024. The market here is projected to grow at a CAGR of 11.7% from 2024 to 2031. However, the region faces challenges such as disparities in healthcare access and economic constraints[1].

Middle East and Africa

The Middle East and Africa region accounts for around 2% of the global revenue, with a market size of USD 52.30 million in 2024. This market is expected to grow at a CAGR of 12.0% from 2024 to 2031, despite facing challenges related to healthcare access and economic constraints[1].

Market Segments

Formulations

The sumatriptan succinate market is segmented into various formulations, including tablets and subcutaneous injections. The tablet segment is significantly influenced by regulatory approvals, pricing strategies, and evolving migraine management practices. The subcutaneous injection segment benefits from advancements in injection technologies and patient training for self-administration[1].

Distribution Channels

Key distribution channels include drug stores, hospital pharmacies, and retail pharmacies. Drug stores play a crucial role in providing over-the-counter access to sumatriptan succinate, while hospital pharmacies ensure timely access within clinical settings[1].

Competitive Landscape

The market for sumatriptan succinate is competitive, with major players such as Pfizer and GlaxoSmithKline. These companies are focusing on strategies to strengthen their product portfolios and expand their market presence. The acquisition of Biohaven Pharmaceutical Holding Company by Pfizer, for instance, is expected to drive incremental revenues and enhance market position[3][5].

Financial Performance and Projections

Revenue Growth

The global sumatriptan succinate market is expected to see significant revenue growth, driven by increasing demand for effective migraine treatments. The market's CAGR of 12.30% from 2024 to 2031 indicates a robust financial trajectory[1].

Key Financial Metrics

• North America: Expected to grow at a CAGR of 10.5% from 2024 to 2031.
• Europe: Anticipated to grow at a CAGR of 10.8% from 2024 to 2031.
• Asia Pacific: Projected to grow at a CAGR of 14.3% from 2024 to 2031[1].

Regulatory Environment

The regulatory environment plays a critical role in shaping the market dynamics of sumatriptan succinate. Stringent regulatory frameworks in regions like North America and Europe ensure product safety and efficacy, fostering confidence in the drug's usage. However, varying regulatory practices across countries, especially in Latin America and the Middle East and Africa, present challenges and opportunities for stakeholders[1].

Technological Advancements

Advancements in healthcare technology, including improvements in injection technologies and patient training for self-administration, are driving the growth of the subcutaneous injection segment. These innovations enhance patient compliance and satisfaction, contributing to the overall market growth[1].

Patient-Centric Solutions

The market is increasingly focusing on patient-centric solutions, including convenient formulations and accessible distribution channels. This shift is driven by the need for effective and convenient migraine management options that align with modern healthcare standards[1].

Challenges and Opportunities

Healthcare Access Disparities

Disparities in healthcare access, particularly in regions like Latin America and the Middle East and Africa, pose significant challenges. Addressing these disparities through targeted strategies and collaborations can unlock new market opportunities[1].

Economic Constraints

Economic constraints impacting patient affordability are another challenge. Companies must navigate these constraints by implementing pricing strategies and access programs to ensure the drug's availability to a broader patient base[1].

Cultural and Regulatory Considerations

Continuous adaptation to evolving healthcare systems and cultural considerations is crucial for success in diverse regional landscapes. Stakeholders must stay attuned to these dynamics to capitalize on market opportunities[1].

Key Takeaways

• The global sumatriptan succinate market is valued at USD 2615.2 million in 2024 and is expected to grow at a CAGR of 12.30% from 2024 to 2031.
• North America, Europe, and Asia Pacific are the major markets, driven by robust healthcare infrastructures and high prevalence of migraines.
• The market is segmented into tablets and subcutaneous injections, with drug stores and hospital pharmacies being key distribution channels.
• Major players like Pfizer and GlaxoSmithKline are focusing on strengthening their product portfolios and expanding market presence.
• Regulatory environments, technological advancements, and patient-centric solutions are key drivers of market growth.

FAQs

Q: What is the current global market size for sumatriptan succinate?

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

Q: What is the projected CAGR for the sumatriptan succinate market from 2024 to 2031?

The market is expected to grow at a CAGR of 12.30% from 2024 to 2031[1].

Q: Which region dominates the sumatriptan succinate market?

North America is the largest market, accounting for more than 40% of the global revenue[1].

Q: What are the key distribution channels for sumatriptan succinate?

Key distribution channels include drug stores, hospital pharmacies, and retail pharmacies[1].

Q: How do technological advancements impact the sumatriptan succinate market?

Technological advancements in injection technologies and patient training for self-administration drive the growth of the subcutaneous injection segment[1].

Sources

1. Cognitive Market Research, Sumatriptan Succinate Market Report 2024 (Global Edition).
2. GSK, Full year and Q4 2021 results.
3. Cognitive Market Research, Imitrex Market Report 2024 (Global Edition).
4. The Scientist, Migraine Drug Research Heats Up As Market Soars.
5. Pfizer Inc, Pfizer Inc to Acquire Biohaven Pharmaceutical Holding Company.