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 nine branded drugs marketed by Meridian Medcl, Glaxosmithkline, Antares Pharma Inc, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Steriscience, 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, Orbion Pharms, 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 twenty patent family members in thirty-one countries.

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

Summary for sumatriptan succinate

International Patents:	420
US Patents:	38
Tradenames:	9
Applicants:	36
NDAs:	41
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	26
Patent Applications:	3,858
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

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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
The Second Hospital of Nanjing Medical University	Phase 3
The Affiliated Hospital of Qingdao University	Phase 3
West China Hospital	Phase 3

See all sumatriptan succinate clinical trials

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
Corepharma	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	200263-002	Jun 19, 2012	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Zydus	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	090310-001	Aug 11, 2010		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Watson Labs	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076933-002	Aug 10, 2009	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006	See Plans and Pricing	See Plans and Pricing
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992	See Plans and Pricing	See Plans and Pricing
>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
Portugal	1161274		See Plans and Pricing
United Kingdom	201000325		See Plans and Pricing
European Patent Office	3331524		See Plans and Pricing
Denmark	1555038		See Plans and Pricing
Israel	238603		See Plans and Pricing
Spain	2612830		See Plans and Pricing
World Intellectual Property Organization (WIPO)	02068030		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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