AZILECT Drug Patent Profile

✉ Email this page to a colleague

When do Azilect patents expire, and what generic alternatives are available?

Azilect is a drug marketed by Teva and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in eighteen countries.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azilect

A generic version of AZILECT was approved as rasagiline mesylate by ORBION PHARMS on March 15^th, 2016.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for AZILECT?
What are the global sales for AZILECT?
What is Average Wholesale Price for AZILECT?

Summary for AZILECT

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	212
Clinical Trials:	27
Patent Applications:	4,069
Drug Prices:	Drug price information for AZILECT
What excipients (inactive ingredients) are in AZILECT?	AZILECT excipients list
DailyMed Link:	AZILECT at DailyMed

Drug patent expirations by year for AZILECT

Recent Clinical Trials for AZILECT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Florida	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
Thomas Guttuso

See all AZILECT clinical trials

Pharmacology for AZILECT

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Paragraph IV (Patent) Challenges for AZILECT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZILECT	Tablets	rasagiline mesylate	0.5 mg and 1 mg	021641	5	2010-05-17

US Patents and Regulatory Information for AZILECT

AZILECT is protected by two US patents.

Patents protecting AZILECT

Rasagiline formulations and processes for their preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Rasagiline formulations of improved content uniformity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARKINSON'S DISEASE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AZILECT

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

International Patents for AZILECT

See the table below for patents covering AZILECT around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Romania	107552	DERIVAT DE 1-AMINOINDAN, PROCEDEU DE OBTINERE SI COMPOZITII FARMACEUTICE CARE CONTININD ACEST DERIVAT (DERIVATE OF 1-AMINOINDANE, PREPARATION PROCESS THEREFOR AND PHARMACEUTICAL COMPOSITION CONTAINING THIS DERIVATE)	⤷ Sign Up
Slovakia	280742		⤷ Sign Up
Netherlands	300206		⤷ Sign Up
Canada	2174449	R-ENANTIOMERE DE N-PROPARGYL-1-AMINO-INDANE, SELS, COMPOSITIONS ET UTILISATION DE CE COMPOSE (R-ENANTIOMER OF N-PROPARGYL-1-AMINOINDAN, SALTS, COMPOSITIONS AND USES THEREOF)	⤷ Sign Up
Iceland	8669	Rasagilínlyfjablöndur sem einsleitni innihaldsefna hefur verið endurbætt í	⤷ Sign Up
Norway	20074823		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AZILECT

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0812190	31/2005	Austria	⤷ Sign Up	PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190	CA 2005 00039	Denmark	⤷ Sign Up
0812190	C00812190/01	Switzerland	⤷ Sign Up	FORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
0812190	SPC024/2005	Ireland	⤷ Sign Up	SPC024/2005, 20060725, EXPIRES: 20191011
0436492	CA 2005 00040	Denmark	⤷ Sign Up
0812190	C300205	Netherlands	⤷ Sign Up	PRODUCT NAME: RASAGILINE, DESGEWENST IN DE VORM VAN EENFARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/04/304/001 T/M 007 20050221
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description