Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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 one supplier. 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. Eighteen 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
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 Amneal Pharmaceuticals 64896-681 64896-681-30 1 BOTTLE, SPRAY in 1 CARTON (64896-681-30) > 1 SPRAY, METERED in 1 BOTTLE, SPRAY
ZOMIG zolmitriptan SPRAY;NASAL 021450 NDA Amneal Pharmaceuticals 64896-681 64896-681-51 6 BOTTLE, SPRAY in 1 CARTON (64896-681-51) > 1 SPRAY, METERED in 1 BOTTLE, SPRAY
Paragraph IV (Patent) Challenges for 021450
Tradename Dosage Ingredient NDA Submissiondate
ZOMIG SPRAY;NASAL zolmitriptan 021450 2016-06-09
ZOMIG SPRAY;NASAL zolmitriptan 021450 2013-11-14

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength2.5MG/SPRAY
Approval Date:Sep 16, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 28, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:May 28, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:Sep 30, 2003TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 28, 2021Product Flag?Substance Flag?Delist Request?Y

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