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Last Updated: December 14, 2019

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Rasagiline mesylate - Generic Drug Details

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What are the generic 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, Micro Labs, Mylan, Orchid Hlthcare, Sandoz Inc, and Watson Labs Inc, and is included in eight 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-seven patent family members in eighteen countries.

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

Drug Prices for rasagiline mesylate

See drug prices for rasagiline mesylate

Recent Clinical Trials for rasagiline mesylate

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

SponsorPhase
Teva Pharmaceutical IndustriesPhase 1
Teva Pharmaceutical IndustriesPhase 4
Technische Universit├Ąt DresdenPhase 4

See all rasagiline mesylate clinical trials

Recent Litigation for rasagiline mesylate

Identify potential future generic entrants

District Court Litigation
Case NameDate
TEVA NEUROSCIENCE, INC. v. WATSON PHARMA, INC.2010-10-01
Valeant International, Bermuda v. Watson Pharmaceuticals Inc.2010-02-19

See all rasagiline mesylate litigation

Generic filers with tentative approvals for RASAGILINE MESYLATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 1MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 0.5MG BASETABLET;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
Synonyms for rasagiline mesylate
(+)-AGN-1135
(1R)-2,3-Dihydro-N-2-propyn-1-yl-1H-inden-1-amine Mesylate
(1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate
(1R)-N-(2-propynyl)-2,3-dihydro-1H-inden-1-amine methanesulfonate
(1R)-N-(prop-2-yn-1-yl)-2,3-dihydro-1H-inden-1-amine; methanesulfonic acid
(R)-2,3-Dihydro-N-2-propynyl-1-indenamine Mesylate
(R)-N-(Prop-2-yn-1-yl)-2,3-dihydro-1H-inden-1-amine methanesulfonate
(R)-N-(prop-2-ynyl)-2,3-dihydro-1H-inden-1-amine methanesulfonate
(R)-N-2-Propynyl-1-indanamine methanesulfonate
161735-79-1
1H-Inden-1-amine, 2,3-dihydro-N-2-propyn-1-yl-, (1R)-, methanesulfonate (1:1)
1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate
1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, (R)-, methanesulfonate
735R791
AB0011313
AB2000506
AC-724
AC1MHJZQ
ACT06733
Agilect
AK-60119
AKOS005145768
AN-6874
ANW-52542
AX8150251
Azilect
Azilect (TN)
BC213842
BG0559
BS-1009
CAS-161735-79-1
CC-34228
CHEMBL1201142
CS-2458
CTK8B6102
D02562
DSSTox_CID_27826
DSSTox_GSID_47848
DSSTox_RID_82589
DTXSID8047848
EN300-123038
FT-0631191
HY-14605
I09-0543
JDBJJCWRXSVHOQ-UTONKHPSSA-N
KB-81371
KS-00000H13
LH8C2JI290
LS-186552
MCULE-3183761977
methanesulfonic acid; (1R)-N-prop-2-ynyl-2,3-dihydro-1H-inden-1-amine
methanesulfonic acid; (1R)-N-prop-2-ynylindan-1-amine
methanesulfonic acid;(1R)-N-prop-2-ynyl-2,3-dihydro-1H-inden-1-amine
MFCD08460604
MolPort-005-937-324
N-Propargyl-1(R)-aminoindan methanesulfonate
NCGC00168774-01
NCGC00168774-02
Q-101873
Rasagiline (mesylate)
Rasagiline mesilate
Rasagiline mesilate (JAN)
Rasagiline mesylate (USAN)
Rasagiline mesylate [USAN]
Rasagiline mesylate, >=98% (HPLC)
Rasagiline methanesulfonate
RL02071
s2102
SC-08804
SCHEMBL158439
ST24049117
TC-064138
Tox21_112635
Tox21_112635_1
TV 1012
TV-1030
TVP 1012
TVP-1012
UNII-LH8C2JI290
Z1820079046

US Patents and Regulatory Information for rasagiline mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201971-002 May 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201823-001 Jul 1, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201823-002 Jul 1, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201970-001 Mar 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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

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

Supplementary Protection Certificates for rasagiline mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0812190 C300205 Netherlands   Start Trial 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
0812190 31/2005 Austria   Start Trial PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190 SPC/GB05/042 United Kingdom   Start Trial 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   Start Trial 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

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