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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 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. Three suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for NDA: 021641

Tradename:
AZILECT
Applicant:
Teva
Ingredient:
rasagiline mesylate
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 Aphena Pharma Solutions - Tennessee, LLC 43353-015 43353-015-18 3000 TABLET in 1 BOTTLE (43353-015-18)
AZILECT
rasagiline mesylate
TABLET;ORAL 021641 NDA Physicians Total Care, Inc. 54868-6206 54868-6206-0 30 TABLET in 1 BOTTLE, PLASTIC (54868-6206-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 16, 2006TE:ABRLD:No
Patent:6,126,968Patent Expiration:Sep 18, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:7,572,834Patent Expiration:Dec 5, 2026Product Flag?YSubstance Flag?Delist Request?
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

Expired Orange Book Patents for NDA: 021641

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 20065,786,390► subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 20065,457,133► subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,387,612► subscribe
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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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