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Generated: July 20, 2019

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Rivastigmine - Generic Drug Details

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

Rivastigmine is the generic ingredient in three branded drugs marketed by Novartis, Alvogen Malta, Amneal Pharms, Mylan Technologies, Zydus Noveltech Inc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm, and Watson Labs, and is included in seventeen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rivastigmine has thirty-seven patent family members in twenty-seven countries.

There are thirty-two drug master file entries for rivastigmine. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for rivastigmine
Medical Subject Heading (MeSH) Categories for rivastigmine
Synonyms for rivastigmine
(R)-Rivastigmine (Rivastigmine EP Impurity D)
(S)-1-(3-((ethyl(methyl)carbamoyl)oxy)phenyl)-N,N-dimethylethanamine
(S)-3-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate
(S)-3-(1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate
(S)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate
[3-[(1S)-1-(dimethylamino)ethyl]phenyl] N-ethyl-N-methyl-carbamate
[3-[(1S)-1-(dimethylamino)ethyl]phenyl] N-ethyl-N-methylcarbamate
[3-[(1S)-1-dimethylaminoethyl]phenyl] N-ethyl-N-methylcarbamate
101R548
123441-03-2
2,3-dihydroxybutanedioic acid; 3-[(1S)-1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate
3-((1S)-1-(Dimethylamino)ethyl)phenyl N-ethyl-N-methylcarbamate
3-((1S)-1-(Dimethylamino)ethyl)phenyl N-ethyl-N-methylcarbamate; Ethylmethylcarbamic acid 3-((1S)-1-(dimethylamino)ethyl)phenyl ester
3-((1S)-1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate
3-((1S)-1-(Dimethylamino)ethyl)phenyl N-ethyl N-methyl carbamate
3-[(1S)-1-(dimethylamino)ethyl]phenyl ethyl(methyl)carbamate
3-[(1S)-1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate
AB01275472_02
AB01275472_03
AB01275472-01
AB1004572
ABP001082
AC-8250
AC1L2U92
AJ-08211
AK161672
AKOS015896334
AN-1074
API0008913
BC225687
BDBM10620
BDBM11682
BIDD:GT0316
C-23825
C11766
Carbamic acid, ethylmethyl-, 3-((1S)-1-(dimethylamino)ethyl)phenyl ester
Carbamic acid, ethylmethyl-, 3-(1-(dimethylamino)ethyl)phenyl ester, (S)-
Carbamic acid, N-ethyl-N-methyl-, 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester
CC-34273
CCG-221197
CHEBI:8874
CHEMBL636
CS-0946
D03822
DB00989
DTXSID7023564
EBD46209
ENA 713 free base
ENA-713
Ethyl-methyl-carbamic acid 3-((R)-1-dimethylamino-ethyl)-phenyl ester
Ethyl-methyl-carbamic acid 3-((S)-1-dimethylamino-ethyl)-phenyl ester
Ethyl-methyl-carbamic acid 3-(1-dimethylamino-ethyl)-phenyl ester
Ethylmethylcarbamic acid 3-((1S)-1-(dimethylamino)ethyl)phenyl ester
Exelon
Exelon Patch
F10108
FT-0651952
GTPL6602
HMS2089H18
HMS3715P15
HY-17368
I06-2037
KS-00000H18
LS-172571
m-((S)-1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate
MLS003876822
MolPort-003-666-662
NCGC00167531-03
Nimvastid
PKI06M3IW0
Prometax (TN)
Rivastigmine (JAN/USAN/INN)
Rivastigmine [USAN:INN:BAN:JAN]
Rivastigmine [USAN:INN]
Rivastigmine Teva
Rivastigmine Transdermal System
Rivastigmine.tartrate
RL06150
S4687
SCHEMBL2764
SDZ 212-713
SDZ-212-713
SDZ-ENA-713
SMR002203623
SR-05000001475
SR-05000001475-1
SR-05000001475-2
ST24049123
UNII-PKI06M3IW0
W-200966
W-5183
XSVMFMHYUFZWBK-NSHDSACASA-N
Y9059
ZINC4413
Generic filers with tentative approvals for RIVASTIGMINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial2MG/MLSOLUTION; ORAL

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

US Patents and Regulatory Information for rivastigmine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Macleods Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 203148-002 Aug 22, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131-002 Oct 22, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131-004 Oct 22, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-006 Apr 21, 2000 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 rivastigmine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for rivastigmine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0193926 SPC/GB98/041 United Kingdom ➤ Try a Free Trial PRODUCT NAME: RIVASTIGMINE, AS FREE BASE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5427501 19970731; CH 5427502 19970731; CH 5427503 19970731; CH 5427504 19970731; CH 5427505 19970731; CH 5427506 19970731; UK EU/1/98/066/001 19980512; UK EU/1/98/066/002 19980512; UK EU/1/98/066/003 19980512; UK EU/1/98/066/004 19980512; UK EU/1/98/066/005 19980512; UK EU/1/98/066/006 19980512; UK EU/1/98/092/023 19980512; UK EU/1/98/092/024 19980512; UK EU/1/98/092/025 19980512; UK EU/1/98/092/026 19980512; UK EU/1/98/066/025 19980512; UK EU/1/98/066/026 19980512; UK EU/1/98/092/019 19980512; UK EU/1/98/092/020 19980512; UK EU/1/98/092/021 19980512; UK EU/1/98/092/022 19980512; UK EU/1/98/0
0193926 98C0038 Belgium ➤ Try a Free Trial PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
0193926 C980031 Netherlands ➤ Try a Free Trial PRODUCT NAME: RIVASTIGMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RIVASTIGMINE WATERSTOFTAR- TRAAT; REGISTRATION NO/DATE: EU/1/98/066/001 - EU/1/98/066/012 19980512
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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