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Zolmitriptan - Generic Drug Details

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Zolmitriptan is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Astrazeneca, Alembic Pharms Ltd, Macleods Pharms Ltd, Ajanta Pharma Ltd, Jubilant Generics, Glenmark Generics, Teva Pharms Usa, IPR, Apotex Inc, Sun Pharma Global, Invagen Pharms, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for zolmitriptan. Nineteen suppliers are listed for this compound.

Summary for Generic Name: zolmitriptan

Tradenames:3
Patents:2
Applicants:14
NDAs:19
Drug Master File Entries: see list20
Suppliers / Packaging: see list19
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Clinical Trials for: zolmitriptan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
ZOMIG-ZMT
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL021231-002Sep 17, 2001RXYes<disabled><disabled>
Astrazeneca
ZOMIG
zolmitriptan
SPRAY;NASAL021450-003Sep 16, 2013RXNo6,750,237*PED<disabled>Y<disabled>
Astrazeneca
ZOMIG
zolmitriptan
SPRAY;NASAL021450-004Sep 30, 2003RXYes7,220,767*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: zolmitriptan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ZOMIG-ZMT
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL021231-001Feb 13, 20015,466,699*PED<disabled>
Astrazeneca
ZOMIG-ZMT
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL021231-002Sep 17, 20015,466,699*PED<disabled>
Astrazeneca
ZOMIG
zolmitriptan
SPRAY;NASAL021450-004Sep 30, 20035,466,699*PED<disabled>
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