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Last Updated: December 4, 2023

Sumatriptan succinate - Generic Drug Details

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What are the generic 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, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz, Somerset, Steriscience, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Endo Ventures Ltd, 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, and Watson Labs, and is included in forty-one NDAs. There are thirty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has four hundred and eight patent family members in thirty-one countries.

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

Summary for sumatriptan succinate

International Patents:	408
US Patents:	37
Tradenames:	8
Applicants:	36
NDAs:	41
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	26
Patent Applications:	3,530
Formulation / Manufacturing:	see details
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

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Drug Sales Revenue Trends for sumatriptan succinate

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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
⤷ Try a Trial	⤷ Try a Trial	EQ 100MG BASE	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 50MG BASE	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076554-002	Aug 10, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Teva Pharms Usa	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	077907-001	Feb 6, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076933-002	Aug 10, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	079240-002	Sep 18, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	200183-001	Sep 16, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for sumatriptan succinate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	⤷ Try a Trial	⤷ Try a Trial
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	⤷ Try a Trial	⤷ Try a Trial
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for sumatriptan succinate

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Country	Patent Number	Title	Estimated Expiration
Poland	2462972		⤷ Try a Trial
Portugal	1161274		⤷ Try a Trial
United Kingdom	2414414	Nasal devices	⤷ Try a Trial
Eurasian Patent Organization	026988	УСИЛЕННЫЕ ПОЛИАМИНОМ СОСТАВЫ ДЛЯ ИОНТОФОРЕЗА СОЕДИНЕНИЯ ТРИПТАНА (POLYAMINE ENHANCED FORMULATIONS FOR TRIPTAN COMPOUND IONTOPHORESIS)	⤷ Try a Trial
Japan	5925844		⤷ Try a Trial
South Korea	20050103941	IONTOPHORETIC DRUG DELIVERY SYSTEM	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	02068032		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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