Details for New Drug Application (NDA): 021641

✉ Email this page to a colleague

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. Twelve 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

Pharmacology for NDA: 021641

Mechanism of Action	Monoamine 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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	May 16, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 5, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Aug 27, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF PARKINSON'S DISEASE

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	May 16, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 5, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021641

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	⤷ Sign Up	⤷ Sign Up
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	⤷ Sign Up	⤷ Sign Up
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.