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. Eight 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
SNBL Clinical Pharmacology Center, Inc.	Phase 1
CoLucid Pharmaceuticals	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
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997		DISCN	No	No

Expired US Patents for IMITREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,554,639*PED
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	4,816,470*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997	5,705,520*PED
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992	4,816,470*PED
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997	5,307,953*PED
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	5,863,559*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
Netherlands	193694
China	1078647
Finland	79530
Hungary	T40077
Austria	386196
South Korea	100232689

Market Dynamics and Financial Trajectory for Imitrex (Sumatriptan)

Last updated: February 13, 2026

Overview

Imitrex (sumatriptan) remains a significant player in the migraine treatment segment. Introduced in 1992 by GlaxoSmithKline (GSK), it is a serotonin receptor agonist primarily used for acute migraine attacks. The drug’s market share, sales trajectory, and future growth prospects are influenced by evolving prescriber preferences, competitive landscape, regulatory developments, and patent statuses.

Market Size and Growth Trends

The global migraine drug market was valued at approximately $3.8 billion in 2022, with an expected compound annual growth rate (CAGR) of 4.2% through 2030 [1]. Imitrex holds a prominent position within this market, especially within the triptan class, which accounted for 65% of the migraine segment in 2022.

Key statistics:

• Estimated global sales of Imitrex: $1.2 billion in 2022.
• Market penetration: Predominant in North America, controlling around 50% of the triptan sales.
• Emerging markets: Growing demand, yet slower adoption due to regulatory hurdles and market awareness.

Competitive Landscape

Imitrex's main competitors include newer triptans like eletriptan (Relpax), rizatriptan (Maxalt), and lasmiditan (Reyvow). The latter introduces a novel mechanism, targeting non-serotonergic pathways, expanding migraine treatment options.

Other key considerations:

• Patent status: The original formulation's patents expired in 2017, allowing for generic entry.
• Generics impact: Generics capture approximately 50-60% of Imitrex's sales since 2018, leading to significant erosion of brand-exclusive revenue.
• Market share retention: GSK continues marketing efforts and maintains a strong clinical profile, aiming to sustain brand presence.

Pricing and Revenue Trends

Post-patent expiration, price erosion occurred:

Year	Average Price per Dose	Imitrex Sales (approx.)
2017	$25	$1.5 billion
2018	$15	$1.1 billion
2022	$10	$1.2 billion (including generics and brand)

Despite price declines, overall sales stabilized due to increased migraine prevalence and wider access. The launch of new formulations (e.g., nasal sprays, auto-injectors) aims to improve adherence and expand the addressable market.

Regulatory and Developmental Pipeline

GSK has focused on product innovations and expanded indications, including potential preventive formulations. Recent approvals or submissions include:

• Sumatriptan nasal powder: Approved in select regions in 2020.
• Combination therapies: Trials for fixed-dose combinations with NSAIDs.
• Analgesic pipeline: No new approvals announced; focus remains on formulations and delivery methods.

Future Outlook

The trajectory depends on multiple factors:

• Patent litigation and exclusivity: Pending patent disputes may delay generic entry or influence pricing strategies.
• Market penetration of alternatives: Emerging drugs with improved efficacy or safety profiles could capture market share.
• Pricing strategies: GSK's ability to differentiate Imitrex through formulations and marketing influences revenue stability.
• Regulatory environment: Potential approval of novel triptan formulations could alter the competitive landscape.

The overall forecast suggests a gradual decline in Imitrex's market share over the next five years but with continued revenue contribution driven by generic demand and formulary placements.

Summary

Key Factor	Impact on Imitrex Revenue	Notes
Patent expiration	Negative	Decline in brand exclusivity since 2017
Generic competition	Significant	50-60% of sales eroded since 2018
Market growth	Moderate	4.2% CAGR projected for migraine drugs overall
New formulations	Neutral/Positive	Expanding treatment options for patients

Key Takeaways

• Imitrex remains a top product within migraine therapies but faces revenue erosion due to patent expiration and generics.
• The global migraine market is expanding modestly, offering growth opportunities in emerging markets.
• Competition from newer triptans and non-triptan drugs threaten Imitrex’s market share.
• GSK’s focus on delivery innovations and pipeline development will influence future revenue stability.
• Price erosion caps upside potential; marketing and formulation differentiation are critical strategies.

FAQs

1. What is the current patent status of Imitrex?
   Patents for the original sumatriptan formulation expired in 2017, leading to generic entries in many markets.

2. How has generic competition affected Imitrex sales?
   Generics have captured approximately 50-60% of Imitrex’s market share since 2018, significantly reducing brand revenues.

3. Are there new formulations of Imitrex available?
   Yes, nasal powders and auto-injectors have been developed and approved in select regions to enhance ease of use.

4. What competitors are challenging Imitrex?
   Other triptans like eletriptan and rizatriptan are competitors, alongside non-serotonergic drugs like lasmiditan.

5. What is the outlook for Imitrex in the next five years?
   Sales are expected to decline gradually due to patent and generic effects, but innovations may sustain revenue levels to some extent.

Sources [1] MarketWatch, "Migraine Drugs Market Size," 2022.