Sumatriptan succinate - Generic Drug Details

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

Sumatriptan succinate is the generic ingredient in eight branded drugs marketed by Meridian Medcl, Glaxosmithkline, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience Speclts, Sun Pharm, Teva Parenteral, Teva Pharms Usa, Wockhardt, Zydus, Currax, Tonix Meds, Teva Branded Pharm, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Vkt Pharma, and Watson Labs, and is included in forty-three NDAs. There are thirty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has three hundred and eighty-two patent family members in thirty-one countries.

There are seventeen drug master file entries for sumatriptan succinate. Thirty-five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for sumatriptan succinate

International Patents:	382
US Patents:	30
Tradenames:	8
Applicants:	34
NDAs:	43
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	26
Patent Applications:	2,672
Drug Prices:	Drug price trends for sumatriptan succinate
What excipients (inactive ingredients) are in sumatriptan succinate?	sumatriptan succinate excipients list
DailyMed Link:	sumatriptan succinate at DailyMed

See drug prices for sumatriptan succinate

See drug sales revenues for sumatriptan succinate

Recent Clinical Trials for sumatriptan succinate

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

Sponsor	Phase
Second Hospital of Jilin University	Phase 3
Beijing Friendship Hospital	Phase 3
The Third Xiangya Hospital of Central South University	Phase 3

See all sumatriptan succinate clinical trials

Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE

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 succinate

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

Anatomical Therapeutic Chemical (ATC) Classes for sumatriptan succinate

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for sumatriptan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	079240-002	Sep 18, 2009		DISCN	No	No
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y

Expired US Patents for sumatriptan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-001	Jun 1, 1995

International Patents for sumatriptan succinate

Country	Patent Number	Title	Estimated Expiration
Japan	6286367
United Kingdom	2408214	Nasal devices
Australia	2822700
Canada	2727927	PHARMACOCINETIQUE D'UNE ADMINISTRATION IONTOPHORETIQUE DE SUMATRIPTAN (PHARMACOKINETICS OF IONTOPHORETIC SUMATRIPTAN ADMINISTRATION)

Sumatriptan Succinate Market Dynamics and Financial Trajectory

Market Overview

Sumatriptan Succinate, a medication used to treat migraines and cluster headaches, is experiencing significant growth in the global pharmaceutical market. The drug works by narrowing blood vessels around the brain and reducing substances that trigger inflammation, providing fast-acting relief for acute migraine attacks[3].

Global Market Size and Growth

As of 2024, the global Sumatriptan Succinate market size is estimated 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, indicating a robust and growing demand for this medication[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 regulatory framework, which ensures product safety and efficacy, along with an aging population, technological advancements in healthcare, and increasing awareness, contribute to the sustained demand. The market in North America is expected to grow at a CAGR of 10.5% from 2024 to 2031[1].

Europe

Europe accounts for over 30% of the global market size, with a value of USD 784.56 million in 2024. The region's well-developed healthcare infrastructure, extensive research capabilities, and high prevalence of migraines drive the market. The subcutaneous injection segment is particularly influenced by advancements in injection technologies and patient training for self-administration. Europe's Sumatriptan Succinate market is expected to grow at a CAGR of 10.8% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 601.50 million in 2024. The increasing prevalence of migraines, a growing population, and improving healthcare infrastructure are key drivers. The market in this region is expected to grow at a CAGR of 14.3% from 2024 to 2031, making it one of the fastest-growing regions[1].

Latin America

Latin America accounts for more than 5% of the global revenue, with a market size of USD 130.76 million in 2024. Despite challenges such as disparities in healthcare access and economic constraints, the market is expected to grow at a CAGR of 11.7% from 2024 to 2031. Hospital pharmacies play a crucial role in providing access to Sumatriptan Succinate in this region[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. The market here is characterized by varying healthcare infrastructures, economic conditions, and cultural attitudes toward healthcare. Despite these challenges, the market is expected to grow at a CAGR of 12.0% from 2024 to 2031[1].

Market Segmentation

The Sumatriptan Succinate market is segmented into several forms, including:

Tablets

Tablets are a popular form of Sumatriptan Succinate, available in various strengths such as 25 mg, 50 mg, and 100 mg. The cost of these tablets can vary based on the strength and quantity, with prices ranging from $18.07 to $18.50 for a supply of 9 tablets[2].

Subcutaneous Injections

Subcutaneous injections are another key segment, offering rapid relief for acute migraine attacks. The cost for a 6 mg/0.5 mL subcutaneous solution can range from $22.25 to $27.99 for 0.5 milliliters[2].

Nasal Sprays

Nasal sprays provide an alternative delivery method, particularly useful for patients who have difficulty swallowing tablets. The cost of nasal sprays varies based on the strength and quantity[2].

Key Drivers and Growth Prospects

Several factors drive the growth of the Sumatriptan Succinate market:

• Increasing Prevalence of Migraines: The rising prevalence of migraines and cluster headaches globally is a significant driver.
• Advancements in Healthcare: Technological advancements in healthcare and improvements in healthcare infrastructure contribute to the market's growth.
• Regulatory Frameworks: Strict regulatory frameworks ensuring the safety and efficacy of pharmaceuticals foster confidence in the use of Sumatriptan Succinate.
• Patient Awareness: Increasing awareness about the benefits and effectiveness of Sumatriptan Succinate in treating migraines is another key driver[1][3].

Challenges and Opportunities

Despite the growth prospects, the market faces several challenges:

• Regulatory Variations: Regulatory frameworks vary across countries, impacting market dynamics.
• Economic Constraints: Economic constraints and disparities in healthcare access, particularly in regions like Latin America and the Middle East & Africa, pose challenges.
• Cultural Attitudes: Diverse cultural attitudes toward healthcare can affect market penetration in some regions[1].

However, these challenges also present opportunities for stakeholders to adapt and innovate. Focus on regulatory compliance, market access strategies, and education and awareness initiatives can help navigate these challenges and leverage market potential.

Competitive Landscape

The Sumatriptan Succinate market is competitive, with key players such as GlaxoSmithKline, Pfizer, Teva, Endo Pharmaceuticals, Mylan, Merck, and Sun Pharmaceutical actively contributing through product innovations, strategic collaborations, and mergers & acquisitions. These companies are driving market growth by enhancing the efficacy and safety profile of Sumatriptan Succinate and expanding market access[3].

Pricing and Cost Considerations

The cost of Sumatriptan Succinate can vary significantly based on the form of the drug, strength, and pharmacy. For example, the cost for a 6 mg/0.5 mL subcutaneous solution can range from $22.25 to $27.99, while oral tablets can cost between $18.07 and $18.50 for a supply of 9 tablets. Insurance coverage, treatment plans, and pharmacy choices also impact the final cost to the patient[2][5].

Key Takeaways

• The global Sumatriptan Succinate market is projected to grow at a CAGR of 12.30% from 2024 to 2031.
• North America, Europe, and Asia Pacific are the leading regions, driven by regulatory frameworks, technological advancements, and increasing awareness.
• The market faces challenges such as regulatory variations and economic constraints but presents opportunities for innovation and adaptation.
• Key players are driving growth through product innovations and strategic collaborations.
• The cost of Sumatriptan Succinate varies based on the form, strength, and pharmacy.

FAQs

1. What is the current global market size of Sumatriptan Succinate? The global Sumatriptan Succinate market size is estimated at USD 2615.2 million as of 2024[1].

2. What is the expected 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].

3. Which region holds the largest market share for Sumatriptan Succinate? North America holds the largest market share, accounting for more than 40% of the global revenue[1].

4. What are the key drivers of the Sumatriptan Succinate market? Key drivers include the increasing prevalence of migraines, advancements in healthcare, regulatory frameworks, and increasing patient awareness[1][3].

5. How does the cost of Sumatriptan Succinate vary? The cost varies based on the form of the drug, strength, and pharmacy, as well as insurance coverage and treatment plans[2][5].

Cited Sources

1. Cognitive Market Research: Sumatriptan Succinate Market Report 2024 (Global Edition)[1].
2. Drugs.com: Sumatriptan Prices, Coupons, Copay Cards & Patient Assistance[2].
3. FrankFurter: Sumatriptan Succinate Market Emerging Trends and Future Prospects[3].
4. Research and Markets: Sumatriptan Succinate Global Market Insights 2024, Analysis and Forecast[4].
5. MedicalNewsToday: Sumatriptan cost 2024: Coupons and more[5].

Last updated: 2024-12-17