ZOLMITRIPTAN - Generic Drug Details

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

Zolmitriptan is the generic ingredient in three branded drugs marketed by Padagis Israel, Amneal, Alembic, Apotex Inc, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Astrazeneca, Ajanta Pharma Ltd, Ani Pharms, Appco, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Sun Pharma Global, Zydus Pharms, and IPR, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for zolmitriptan. Twenty-one suppliers are listed for this compound.

Summary for ZOLMITRIPTAN

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	26
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	23
Patent Applications:	6,643
Drug Prices:	Drug price trends for ZOLMITRIPTAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOLMITRIPTAN
What excipients (inactive ingredients) are in ZOLMITRIPTAN?	ZOLMITRIPTAN excipients list
DailyMed Link:	ZOLMITRIPTAN at DailyMed

See drug prices for ZOLMITRIPTAN

Recent Clinical Trials for ZOLMITRIPTAN

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

Sponsor	Phase
Parc de Salut Mar	Phase 1
Food and Drug Administration (FDA)	Phase 1
William Stoops	Early Phase 1

See all ZOLMITRIPTAN clinical trials

Pharmacology for ZOLMITRIPTAN

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 ZOLMITRIPTAN

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

Paragraph IV (Patent) Challenges for ZOLMITRIPTAN

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 ZOLMITRIPTAN

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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
Macleods Pharms Ltd	ZOLMITRIPTAN	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	204336-002	Oct 22, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	ZOLMITRIPTAN	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	202855-002	Sep 20, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	201779-001	May 14, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jubilant Generics	ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	202279-001	Nov 20, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	204232-001	Sep 30, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 ZOLMITRIPTAN

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

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