AZILECT Drug Patent Profile

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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.

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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:	4,075
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

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Glossary

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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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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

International Patents for AZILECT

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

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Country	Patent Number	Title	Estimated Expiration
Norway	975331		⤷ Sign Up
Israel	115357	Stable compositions containing N-propargyl-1-aminoindan and polyhydric alcohols	⤷ Sign Up
Japan	2008531572		⤷ Sign Up
Spain	2287940		⤷ Sign Up
China	1096853		⤷ Sign Up
Czechoslovakia	9100006		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AZILECT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0812190	C00812190/01	Switzerland	⤷ Sign Up	FORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
0812190	31/2005	Austria	⤷ Sign Up	PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190	SPC/GB05/042	United Kingdom	⤷ Sign Up	PRODUCT NAME: MESYLATE, ESYLATE OR SULFATE SALTS OF N-PROPARGYL-1(R)-AMINOINDAN (RASAGILINE); REGISTERED: UK EU/1/04/304/001 20050221; UK EU/1/04/304/002 20050221; UK EU/1/04/304/003 20050221; UK EU/1/04/304/004 20050221; UK EU/1/04/304/005 20050221; UK EU/1/04/304/006 20050221; UK EU/1/04/304/007 20050221
0436492	CA 2005 00040	Denmark	⤷ Sign Up
0812190	SPC024/2005	Ireland	⤷ Sign Up	SPC024/2005, 20060725, EXPIRES: 20191011
0812190	05C0033	France	⤷ Sign Up	PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description