RASAGILINE MESYLATE - Generic Drug Details

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What are the generic drug sources for rasagiline mesylate and what is the scope of freedom to operate?

Rasagiline mesylate is the generic ingredient in two branded drugs marketed by Teva, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Carnegie, Chartwell Rx, Indoco, Micro Labs, Orbion Pharms, Skg Pharma, and Watson Labs Inc, and is included in eleven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rasagiline mesylate has twenty-six patent family members in eighteen countries.

There are eighteen drug master file entries for rasagiline mesylate. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for RASAGILINE MESYLATE

International Patents:	26
US Patents:	2
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	14
Patent Applications:	327
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for RASAGILINE MESYLATE
What excipients (inactive ingredients) are in RASAGILINE MESYLATE?	RASAGILINE MESYLATE excipients list
DailyMed Link:	RASAGILINE MESYLATE at DailyMed

See drug prices for RASAGILINE MESYLATE

Recent Clinical Trials for RASAGILINE MESYLATE

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

Sponsor	Phase
Teva Pharmaceutical Industries	Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 1
Teva Pharmaceutical Industries	Phase 4

See all RASAGILINE MESYLATE clinical trials

Generic filers with tentative approvals for RASAGILINE MESYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 1MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 0.5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for RASAGILINE MESYLATE

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RASAGILINE MESYLATE

N04BD	Monoamine oxidase B inhibitors
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for RASAGILINE MESYLATE

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 RASAGILINE MESYLATE

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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			⤷ Sign Up
Carnegie	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201942-001	Nov 18, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	207004-002	Mar 29, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201950-001	Sep 12, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201889-001	Oct 30, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orbion Pharms	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201970-001	Mar 15, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201889-002	Oct 30, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 RASAGILINE MESYLATE

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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	021641-001	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	021641-001	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 RASAGILINE MESYLATE

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Country	Patent Number	Title	Estimated Expiration
South Africa	200707469	Rasagiline formulations of improved content uniformity	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006091657		⤷ Sign Up
Japan	2008531572		⤷ Sign Up
China	101123946	Rasagiline formulations of improved content uniformity	⤷ Sign Up
Japan	2013139452	RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY	⤷ Sign Up
South Korea	20180026580	함량 균일성이 개선된 라사길린 제형 (RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY)	⤷ Sign Up
Canada	2901244	PREPARATIONS DE RASAGILINE PRESENTANT UNE UNIFORMITE DE TENEUR AMELIOREE (RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RASAGILINE MESYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
0812190	31/2005	Austria	⤷ Sign Up	PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
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

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