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Sumatriptan - Generic Drug Details

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

Sumatriptan is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Lannett Co Inc, Perrigo Uk Finco, Upsher Smith Labs, Meridian Medcl, Antares Pharma Inc, Aurobindo Pharma Ltd, Dr Reddys, Fresenius Kabi Usa, Hikma, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Endo Ventures Ltd, Currax, Teva Branded Pharm, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty-four NDAs. There are forty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan has sixty-one patent family members in nineteen countries.

There are twenty-four drug master file entries for sumatriptan. Six suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for sumatriptan

International Patents:	61
US Patents:	47
Tradenames:	10
Applicants:	36
NDAs:	44
Drug Master File Entries:	24
Suppliers / Packagers:	6
Bulk Api Vendors:	48
Clinical Trials:	106
Patent Applications:	5,517
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for sumatriptan
Drug Sales Revenues:	Drug sales revenues for sumatriptan
DailyMed Link:	sumatriptan at DailyMed

See drug prices for sumatriptan

See drug sales revenues for sumatriptan

Recent Clinical Trials for sumatriptan

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

Sponsor	Phase
Cambridge University Hospitals NHS Foundation Trust	Early Phase 1
Pfizer	Phase 1
Zagazig University	N/A

See all sumatriptan clinical trials

Generic filers with tentative approvals for SUMATRIPTAN

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

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

Medical Subject Heading (MeSH) Categories for sumatriptan

Serotonin 5-HT1 Receptor Agonists

Vasoconstrictor Agents

US Patents and Regulatory Information for sumatriptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076840-002	Feb 9, 2009		DISCN	No	No
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y
Upsher Smith Labs	ZEMBRACE SYMTOUCH	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	208223-001	Jan 28, 2016		RX	Yes	No
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y
Hikma Pharms	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	078298-003	May 21, 2013		DISCN	No	No
Fresenius Kabi Usa	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	079240-001	Sep 18, 2009		DISCN	No	No

Expired US Patents for sumatriptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997

International Patents for sumatriptan

Country	Patent Number	Estimated Expiration
Israel	276485
World Intellectual Property Organization (WIPO)	2011014797
United Kingdom	202012086
South Africa	201202168
Canada	3088989
Canada	2748268