ZOMIG Drug Patent Profile

Which patents cover Zomig, and what generic alternatives are available?

Zomig is a drug marketed by Amneal, IPR, and Astrazeneca. and is included in three NDAs.

The generic ingredient in ZOMIG is zolmitriptan. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zomig

A generic version of ZOMIG was approved as zolmitriptan by GLENMARK PHARMS LTD on May 14^th, 2013.

Summary for ZOMIG

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Patent Applications:	4,317
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZOMIG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOMIG
What excipients (inactive ingredients) are in ZOMIG?	ZOMIG excipients list
DailyMed Link:	ZOMIG at DailyMed

See drug prices for ZOMIG

Pharmacology for ZOMIG

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 ZOMIG

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

Paragraph IV (Patent) Challenges for ZOMIG

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOMIG	Nasal Spray	zolmitriptan	2.5 mg/spray	021450	1	2016-06-09
ZOMIG	Nasal Spray	zolmitriptan	5 mg/spray	021450	1	2013-11-14

US Patents and Regulatory Information for ZOMIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	AB	RX	Yes	No
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-002	Nov 25, 1997		DISCN	Yes	No
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	AB	RX	Yes	Yes
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-001	Nov 25, 1997		DISCN	Yes	No
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-002	Sep 17, 2001		DISCN	Yes	No

Expired US Patents for ZOMIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-001	Nov 25, 1997
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-002	Nov 25, 1997
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-002	Nov 25, 1997

International Patents for ZOMIG

See the table below for patents covering ZOMIG around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	149578	PHARMACEUTICAL FORMULATIONS CONTAINING ZOLMITRIPTAN AND PROCESS FOR THEIR PREPARATION
Mexico	PA02005319	FORMULACIONES FARMACEUTICAS QUE CONTIENEN ZOLMITRIPTAN. (PHARMACEUTICAL FORMULATIONS CONTAINING ZOLMITRIPTAN.)
Poland	357597
Slovenia	9111010	3,5-DISUBSTITUTED INDOLE DERIVATIVES AS "5-HT1-SIMILAR" RECEPTOR AGONISTS
Lithuania	3264	THERAPEUTIC HETEROCYCLIC COMPOUNDS

Supplementary Protection Certificates for ZOMIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0486666	72/1997	Austria		PRODUCT NAME: ZOLMITRIPTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ZULAESSIGEN SALZES; NAT. REGISTRATION NO/DATE: 1-22068, 1-22069 19970819; FIRST REGISTRATION: GB 12619/0116, 12619/0117 19970307
0463756	300048	Netherlands		PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307
0486666	C980001	Netherlands		PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 21079, RVG 21080 19970925; FIRST REGISTRATION: GB PL 12619/0116 19970307
0486666	SPC/GB97/089	United Kingdom		PRODUCT NAME: ZOLMITRIPTAN AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 12619/0116 19970307