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Federal Trade Commission
Daiichi Sankyo
Dow
McKinsey
Chubb
Johnson and Johnson
QuintilesIMS
Julphar
Farmers Insurance

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021450

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NDA 021450 describes ZOMIG, which is a drug marketed by Astrazeneca and IPR and is included in three NDAs. It is available from four suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZOMIG profile page.

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.
Summary for 021450
Tradename:ZOMIG
Applicant:Astrazeneca
Ingredient:zolmitriptan
Patents:2
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021450
Suppliers and Packaging for NDA: 021450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOMIG zolmitriptan SPRAY;NASAL 021450 NDA Rebel Distributors Corp 21695-955 E 21695-955-06
ZOMIG zolmitriptan SPRAY;NASAL 021450 NDA Impax Specialty Pharma 64896-681 N 64896-681-30

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength2.5MG/SPRAY
Approval Date:Sep 16, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 12, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:May 28, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:May 28, 2021Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Argus Health
Covington
Express Scripts
Fish and Richardson
Teva
Julphar
Johnson and Johnson
Citi

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