FROVATRIPTAN SUCCINATE - Generic Drug Details

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

Frovatriptan succinate is the generic ingredient in two branded drugs marketed by Endo Operations, Amneal Pharms Co, Glenmark Pharms Ltd, Leading, Pharmobedient, and Renata, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for frovatriptan succinate. Four suppliers are listed for this compound.

Summary for FROVATRIPTAN SUCCINATE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	204
What excipients (inactive ingredients) are in FROVATRIPTAN SUCCINATE?	FROVATRIPTAN SUCCINATE excipients list
DailyMed Link:	FROVATRIPTAN SUCCINATE at DailyMed

Pharmacology for FROVATRIPTAN 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 FROVATRIPTAN SUCCINATE

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

Paragraph IV (Patent) Challenges for FROVATRIPTAN SUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FROVA	Tablets	frovatriptan succinate	2.5 mg	021006	1	2011-03-09

US Patents and Regulatory Information for FROVATRIPTAN SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	211292-001	Nov 6, 2018	AB	RX	No	No
Glenmark Pharms Ltd	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	204730-001	Mar 11, 2016	AB	RX	No	No
Pharmobedient	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	202931-001	Aug 28, 2014		DISCN	No	No
Renata	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	213891-001	Apr 6, 2022	AB	RX	No	Yes
Leading	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	216998-001	Apr 16, 2025	AB	RX	No	No
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001		DISCN	Yes	No

Expired US Patents for FROVATRIPTAN SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001