Sumatriptan - Generic Drug Details

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What are the generic sources for sumatriptan and what is the scope of freedom to operate?

Sumatriptan is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Adaptis, Cipla, Lannett Co Inc, Padagis Israel, Tonix Meds, Meridian Medcl, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience Speclts, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Currax, 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-seven NDAs. There are forty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan has ninety-one patent family members in twenty-nine countries.

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

Summary for sumatriptan

International Patents:	91
US Patents:	41
Tradenames:	10
Applicants:	38
NDAs:	47
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	115
Patent Applications:	6,435
Drug Prices:	Drug price trends for sumatriptan
Drug Sales Revenues:	Drug sales revenues for sumatriptan
What excipients (inactive ingredients) are in sumatriptan?	sumatriptan excipients list
DailyMed Link:	sumatriptan at DailyMed

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Drug Sales Revenue Trends for sumatriptan

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Recent Clinical Trials for sumatriptan

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

Sponsor	Phase
Radboud University Medical Center	Phase 2
Canisius-Wilhelmina Hospital	Phase 2
Leiden University Medical Center	Phase 2

See all sumatriptan clinical trials

Generic filers with tentative approvals for SUMATRIPTAN

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

Medical Subject Heading (MeSH) Categories for sumatriptan

Serotonin 5-HT1 Receptor Agonists
Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for sumatriptan

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for sumatriptan

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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
Teva	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076840-001	Feb 9, 2009		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Sun Pharm Inds	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	078295-001	Aug 10, 2009	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Roxane	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	078241-002	Aug 10, 2009		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997	5,037,845*PED	⤷ Subscribe
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,705,520*PED	⤷ Subscribe
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,037,845*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for sumatriptan

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Galpharm Healthcare Ltd.	Sumatriptan Galpharm	sumatriptan	EMEA/H/C/002140	Refused	yes	no	no		2012-02-09
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for sumatriptan

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Country	Patent Number	Title	Estimated Expiration
Australia	2024201523	Intranasal epinephrine formulations and methods for the treatment of disease	⤷ Subscribe
South Korea	102375232		⤷ Subscribe
Japan	2015108008	薬物投与のための組成物 (COMPOSITIONS FOR DRUG ADMINISTRATION)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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