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Sumatriptan succinate - Generic Drug Details

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

Sumatriptan succinate is the generic ingredient in nine branded drugs marketed by Meridian Medcl, Glaxosmithkline, Antares Pharma Inc, Aurobindo Pharma Ltd, Caplin, 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, Upsher Smith Labs, Padagis Israel, 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-one NDAs. There are thirty-eight 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 eighteen patent family members in thirty countries.

There are twenty-four 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:	418
US Patents:	38
Tradenames:	9
Applicants:	36
NDAs:	41
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	22
Patent Applications:	2,213
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for sumatriptan succinate
Drug Sales Revenues:	Drug sales revenues 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
The Second Hospital of Nanjing Medical University	Phase 3
Second Affiliated Hospital of Wenzhou Medical University	Phase 3
Peking University Third Hospital	Phase 3

See all sumatriptan succinate clinical trials

Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE

Applicant	Application No.	Strength	Dosage Form
		EQ 25MG BASE	TABLET;ORAL
		EQ 100MG BASE	TABLET;ORAL
		EQ 50MG 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 1d Receptor Agonists Serotonin 1b Receptor Agonists

Paragraph IV (Patent) Challenges for SUMATRIPTAN SUCCINATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
IMITREX	TABLET;ORAL	sumatriptan succinate	020132

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
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y
Dr Reddys Labs Inc	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076847-002	Aug 10, 2009	AB	RX	No	No
Hikma Pharms	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	078298-002	May 21, 2013		DISCN	No	No
Sandoz Inc	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	078067-001	Feb 6, 2009		DISCN	No	No
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	AB	RX	Yes	No
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No			Y

Expired US Patents for sumatriptan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-001	Jun 1, 1995
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995

International Patents for sumatriptan succinate

Country	Patent Number	Estimated Expiration
European Patent Office	2340865
South Africa	201008859
United Kingdom	201000312
World Intellectual Property Organization (WIPO)	03077973
Brazil	0207560
United Kingdom	0706863
Japan	2008513078