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Generated: September 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021641

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NDA 021641 describes AZILECT, which is a drug marketed by Teva and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AZILECT profile page.

The generic ingredient in AZILECT is rasagiline mesylate. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
Summary for 021641
Tradename:AZILECT
Applicant:Teva
Ingredient:rasagiline mesylate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021641
Mechanism of ActionMonoamine Oxidase Inhibitors
Suppliers and Packaging for NDA: 021641
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZILECT rasagiline mesylate TABLET;ORAL 021641 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3060 0093-3060-56 30 TABLET in 1 BOTTLE (0093-3060-56)
AZILECT rasagiline mesylate TABLET;ORAL 021641 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3061 0093-3061-56 30 TABLET in 1 BOTTLE (0093-3061-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 16, 2006TE:ABRLD:Yes
Patent:  Try a Free TrialPatent Expiration:Dec 5, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:  Try a Free TrialPatent Expiration:Aug 27, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:May 16, 2006TE:ABRLD:Yes
Patent:  Try a Free TrialPatent Expiration:Dec 5, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021641

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006   Try a Free Trial   Try a Free Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006   Try a Free Trial   Try a Free Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006   Try a Free Trial   Try a Free Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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