Sumatriptan succinate - Generic Drug Details

What are the generic drug 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, 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, 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 NDAs. There are thirty-nine 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 nineteen patent family members in thirty-one countries.

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

Summary for sumatriptan succinate

International Patents:	419
US Patents:	39
Tradenames:	8
Applicants:	35
NDAs:	40
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	26
Patent Applications:	3,921
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 Affiliated Hospital of Kunming Medical University	Phase 3
Second Hospital of Jilin University	Phase 3
Beijing Friendship Hospital	Phase 3

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 1b Receptor Agonists Serotonin 1d Receptor Agonists

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
Zydus	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	090310-001	Aug 11, 2010		DISCN	No	No
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y
Roxane	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	078241-001	Aug 10, 2009		DISCN	No	No
Sun Pharm Inds Ltd	SUMATRIPTAN SUCCINATE	sumatriptan succinate	TABLET;ORAL	076554-002	Aug 10, 2009	AB	RX	No	No
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes			Y

Expired US Patents for sumatriptan succinate

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
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995
Endo Ventures Ltd	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-001	Jun 1, 1995
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-001	Jun 1, 1995

International Patents for sumatriptan succinate

Country	Patent Number	Title	Estimated Expiration
Japan	4688416
Japan	2011524901
Canada	2727927	PHARMACOCINETIQUE D'UNE ADMINISTRATION IONTOPHORETIQUE DE SUMATRIPTAN (PHARMACOKINETICS OF IONTOPHORETIC SUMATRIPTAN ADMINISTRATION)
Japan	4959906
European Patent Office	2136865	ADMINISTRATION NASALE (NASAL DELIVERY)
Canada	2918226	DISPOSITIF D'ADMINISTRATION NASALE SERVANT A ADMINISTRER UNE SUBSTANCE DANS UNE CAVITE NASALE D'UN SUJET (NASAL DELIVERY DEVICE FOR DELIVERING SUBSTANCE TO A NASAL CAVITY OF A SUBJECT)