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, 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, Tonix Meds, 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-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has three hundred and eighty-two patent family members in thirty-one countries.

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

Summary for sumatriptan succinate

International Patents:	382
US Patents:	31
Tradenames:	8
Applicants:	34
NDAs:	41
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	26
Patent Applications:	3,326
Drug Prices:	Drug price trends 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
Second Hospital of Jilin University	Phase 3
Beijing Friendship Hospital	Phase 3
The Third Xiangya Hospital of Central South University	Phase 3

See all sumatriptan succinate clinical trials

Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 100MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 50MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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 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
Endo Operations	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	077332-001	Oct 9, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Inc	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076847-002	Aug 10, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orbion Pharms	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	078284-001	Aug 10, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Dr Reddys	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	090495-001	Jan 29, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	⤷ Sign Up	⤷ Sign Up
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	⤷ Sign Up	⤷ Sign Up
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	⤷ Sign Up	⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013	⤷ Sign Up	⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	⤷ Sign Up	⤷ Sign Up
>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
United Kingdom	0121568		⤷ Sign Up
United Kingdom	2465098	Nasal delivery device with temperature modifier	⤷ Sign Up
Brazil	0207560		⤷ Sign Up
Canada	2479316	NOUVEL APPAREIL (NOVEL DEVICE)	⤷ Sign Up
Australia	2002302868		⤷ Sign Up
Eurasian Patent Organization	026988	УСИЛЕННЫЕ ПОЛИАМИНОМ СОСТАВЫ ДЛЯ ИОНТОФОРЕЗА СОЕДИНЕНИЯ ТРИПТАНА (POLYAMINE ENHANCED FORMULATIONS FOR TRIPTAN COMPOUND IONTOPHORESIS)	⤷ Sign Up
Australia	2009335085	Electronic control of drug delivery system	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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