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Generated: December 18, 2017

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 four suppliers. There are four 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. Seven suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for 021641

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Antiparkinson Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 16, 2006TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 29, 2017
Regulatory Exclusivity Use:EXPANDED INDICATION OF RASAGILINE AS AN ADD-ON THERAPY TO STABLE DOSES OF DOPAMINE AGONISTS IN THE TREATMENT OF EARLY PARKINSON'S DISEASE
Patent:► SubscribePatent Expiration:Feb 7, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE
Patent:► SubscribePatent Expiration:Sep 18, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021641

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Argus Health
Federal Trade Commission
Covington
Healthtrust
Baxter
Cantor Fitzgerald
Daiichi Sankyo
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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