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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, 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, Upsher Smith Labs, 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 thirty-nine NDAs. There are forty 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 sixteen patent family members in thirty countries.

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

Summary for sumatriptan succinate

International Patents:	416
US Patents:	40
Tradenames:	8
Applicants:	34
NDAs:	39
Drug Master File Entries:	24
Suppliers / Packagers:	31
Bulk Api Vendors:	102
Clinical Trials:	21
Patent Applications:	2,159
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
Kimberly-Clark Corporation	Phase 1
Cady, Roger, M.D.	Phase 4
GlaxoSmithKline	Phase 4

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 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
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	AB	RX	Yes	No
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	AB	RX	Yes	No
Teva Parenteral	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	078318-002	Feb 6, 2009		DISCN	No	No

Expired US Patents for sumatriptan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009

International Patents for sumatriptan succinate

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012071175
Japan	2005500877
China	1217712