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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Cipla
Julphar
McKesson
AstraZeneca
Chubb
US Army
Cantor Fitzgerald

Generated: May 21, 2018

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Rasagiline mesylate - Generic Drug Details

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

Rasagiline mesylate
is the generic ingredient in two branded drugs marketed by Teva, Alkem Labs Ltd, Apotex Inc, Mylan Pharms Inc, Orchid Hlthcare, and Watson Labs Inc, and is included in six 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. Eight suppliers are listed for this compound. There are three tentative approvals for this compound.
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-(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-2-Propynyl-1-indanamine methanesulfonate
161735-79-1
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
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
OR227636
Q-101873
Rasagiline (mesylate)
Rasagiline mesilate
Rasagiline mesilate (JAN)
Rasagiline mesylate (USAN)
Rasagiline mesylate [USAN]
Rasagiline mesylate, >=98% (HPLC)
Rasagiline methanesulfonate
RL02071
s2102
SBB062837
SC-08804
SCHEMBL158439
ST24049117
TC-064138
Tox21_112635
Tox21_112635_1
TV 1012
TV-1030
TVP 1012
TVP-1012
UNII-LH8C2JI290
Z1820079046
Tentative approvals for RASAGILINE MESYLATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial0.5MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial1MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free TrialEQ 1MG BASETABLET;ORAL

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
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Watson Labs Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201823-002 Jul 1, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for rasagiline mesylate

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

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Non-Orange Book US Patents for rasagiline mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,598,420 Rasagiline formulations and processes for their preparation ➤ Try a Free Trial
7,619,117 Rasagiline formulations and processes for their preparation ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for rasagiline mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00205 Netherlands ➤ Try a Free 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
C0033 France ➤ Try a Free Trial PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
/2005 Austria ➤ Try a Free Trial PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
C/GB05/042 United Kingdom ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Julphar
Federal Trade Commission
Cantor Fitzgerald
Dow
Medtronic
Teva
Boehringer Ingelheim
Healthtrust

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 verifification 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.