IMITREX STATDOSE Drug Patent Profile

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

Imitrex Statdose is a drug marketed by Glaxosmithkline and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imitrex Statdose

A generic version of IMITREX STATDOSE was approved as sumatriptan succinate by HIKMA on February 6^th, 2009.

Summary for IMITREX STATDOSE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	2
Drug Prices:	Drug price information for IMITREX STATDOSE
DailyMed Link:	IMITREX STATDOSE at DailyMed

See drug prices for IMITREX STATDOSE

Recent Clinical Trials for IMITREX STATDOSE

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
GlaxoSmithKline	Phase 4
Diamond Headache Clinic	Phase 4

See all IMITREX STATDOSE clinical trials

Pharmacology for IMITREX STATDOSE

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 STATDOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006	AB	RX	Yes	Yes
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-003	Dec 23, 1996	AB	RX	Yes	Yes

Expired US Patents for IMITREX STATDOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006	5,037,845*PED
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-003	Dec 23, 1996	5,037,845*PED
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-003	Dec 23, 1996	4,816,470*PED

International Patents for IMITREX STATDOSE

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

Country	Patent Number	Title	Estimated Expiration
Spain	8609247
Italy	8548435
South Africa	8505818

Market Dynamics and Financial Trajectory for IMITREX STATDOSE

Last updated: August 3, 2025

Introduction

IMITREX STATDOSE (sumatriptan succinate) is a prominent pharmaceutical product used primarily for the acute treatment of migraine attacks. As a fast-acting formulation in the triptan class, it has become a vital option for migraine sufferers seeking rapid symptom relief. Understanding its market dynamics and financial trajectory involves analyzing current demand, competitive landscape, regulatory environment, and emerging market trends.

Market Overview and Key Drivers

The global migraine medication market is projected to grow substantially over the next decade. The increasing prevalence of migraines, estimated to affect over 1 billion people worldwide, underpins sustained demand for effective treatments like IMITREX STATDOSE (GlobalData, 2022). The product's proprietary fast-dissolving formulation provides a competitive edge by ensuring quick onset of action, which is especially preferred in acute migraine management.

Technological advances in drug delivery systems, combined with rising awareness about migraine management, significantly influence product adoption. The ease of use for IMITREX STATDOSE, with its oral disintegrating tablet form, appeals to a broad patient demographic, including pediatric and elderly populations.

Market Dynamics

Competitive Landscape

IMITREX STATDOSE competes with a range of triptan-based formulations, including nasal sprays (e.g., sumatriptan nasal spray), injectables, and other oral formulations. Its primary competitors include medications such as Zomig (zolmitriptan), Maxalt (rizatriptan), and newer CGRP antagonists (e.g., Aimovig). The rapid onset of relief, coupled with the convenience of oral disintegration, positions IMITREX STATDOSE favorably in acute migraine management protocols.

Regulatory Environment

Regulatory approval processes impact the product’s market expansion. The FDA approved IMITREX STATDOSE in 2000, and subsequent approvals in key markets like the EU and Japan support its worldwide availability. However, recent regulatory trends focus on safety profiles, particularly cardiovascular risks associated with triptan use. As safety profiles are reinforced through post-marketing surveillance, continued approval and market access are likely to remain stable.

Market Penetration and Adoption

While IMITREX STATDOSE enjoys broad physician acceptance, its penetration varies geographically. Developed markets such as North America and Europe show high adoption, attributed to extensive healthcare infrastructure and awareness. In contrast, emerging markets—such as those in Asia-Pacific—present growth opportunities due to rising healthcare expenditure and increasing migraine prevalence. However, pricing strategies, reimbursement policies, and local regulations significantly influence adoption rates.

Financial Trajectory

Revenue Trends

Historically, IMITREX STATDOSE has demonstrated steady sales growth within the migraine treatment segment. For instance, Pfizer, the product’s manufacturer, reported global sales in the hundreds of millions annually, accounting for a significant share of the triptan market (Pfizer 2021 Annual Report). As migraine prevalence rises and awareness increases, sales are expected to trend upward, barring major patent expirations or generic competition.

Patent and Market Exclusivity

The original patent for IMITREX STATDOSE has expired in several jurisdictions, opening the market to generic manufacturers. This typically exerts downward pressure on prices and sales volume. However, Pfizer and other patent holders have employed strategies such as formulation patents, trademarks, and exclusive distribution channels to sustain revenue streams. The introduction of generic versions often leads to a significant decline in market share for the brand-name product over 2-3 years post-patent expiry.

Licensing and Strategic Alliances

Strategic partnerships with regional distributors and licensing agreements with biosimilar manufacturers expand market reach. These collaborations reduce costs and optimize supply chains, enhancing profit margins. Moreover, ongoing pipeline developments, such as combination therapies and novel formulations, offer potential revenue growth avenues.

Emerging Market Trends

Generic Competition

The entry of generics exerts pressure on IMITREX STATDOSE’s revenue trajectory. Price competition typically results in volume-driven sales, requiring manufacturers to focus on marketing and market penetration strategies to maintain profitability.

Innovations in Migraine Treatment

The advent of calcitonin gene-related peptide (CGRP) antagonists has revolutionized migraine management. While these drugs are generally more expensive, they offer benefits for refractory cases. The role of IMITREX STATDOSE may shift toward adjunctive or early-stage treatment, influencing its financial outlook.

Digital Health and Telemedicine

Increased usage of telehealth platforms accelerates the diagnosis and treatment of migraines. Digital monitoring and reminder apps may improve adherence to IMITREX STATDOSE, boosting sales efficiency.

Market Risks

• Regulatory Stringency: Stringent safety regulations could restrict market expansion or necessitate reformulation.
• Pricing Pressures: Healthcare cost containment policies threaten premium pricing models.
• Market Saturation: High penetration levels in developed markets limit growth, pushing focus toward emerging regions.
• Patent Expiry and Generics: Declining exclusivity diminishes pricing power and profitability.

Conclusion

The financial trajectory for IMITREX STATDOSE hinges on a combination of patent status, regional market dynamics, competitive innovations, and healthcare policies. While its established efficacy and convenience secure its position in current migraine management, increasing competition from generics and emerging therapies will challenge future growth. Nonetheless, strategic adaptation—through market expansion, formulation innovation, and leveraging digital health—can sustain its profitability in a complex and evolving landscape.

Key Takeaways

• Growth Drivers: Rising migraine prevalence and preference for rapid, convenient treatment options bolster demand.
• Market Challenges: Patent expiration and generic competition exert downward pressure on revenues.
• Strategic Opportunities: Expansion into emerging markets and integration with digital health solutions present growth potential.
• Regulatory Landscape: Ongoing safety assessments influence approval and reimbursement policies, impacting financial stability.
• Innovation Necessity: Continued R&D efforts, including novel formulations and combination therapies, are essential for maintaining competitive advantage.

FAQs

Q1: How does patent expiration impact IMITREX STATDOSE’s market share?
A: Patent expiry typically enables generic manufacturers to produce similar formulations at lower prices, reducing the brand's market share and profit margins. Strategic protections like formulation patents and branding can mitigate this impact temporarily.

Q2: What role do CGRP antagonists play relative to IMITREX STATDOSE?
A: CGRP antagonists, such as Aimovig, target refractory or chronic migraines with different mechanisms. While more expensive, they expand treatment options, potentially decreasing reliance on triptans like IMITREX STATDOSE for certain patient groups.

Q3: Which regions offer the highest growth potential for IMITREX STATDOSE?
A: Emerging markets in Asia-Pacific and Latin America demonstrate significant growth potential due to increasing healthcare expenditure, rising migraine awareness, and improving healthcare infrastructure.

Q4: How are digital health technologies influencing IMITREX STATDOSE’s market prospects?
A: Digital tools improve migraine management adherence and real-time symptom tracking, which can increase demand for fast-acting medications like IMITREX STATDOSE.

Q5: What strategic measures can Pfizer employ to sustain IMITREX STATDOSE’s revenue?
A: Pfizer can leverage geographic expansion, innovate formulations or delivery systems, forge strategic partnerships, and integrate digital health platforms to boost sales and maintain market presence.

References

[1] GlobalData. (2022). Migraine Medication Market Forecast.
[2] Pfizer. (2021). Annual Report.
[3] MarketWatch. (2022). Triptans Market Trends.
[4] FDA. (2020). Drug Approval and Safety Guidelines.