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Last Updated: December 7, 2019

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RIVASTIGMINE - Generic Drug Details

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What are the generic sources for rivastigmine and what is the scope of patent protection?

Rivastigmine is the generic ingredient in three branded drugs marketed by Novartis, Alvogen, 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.

Drug Prices for RIVASTIGMINE

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Recent Clinical Trials for RIVASTIGMINE

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SponsorPhase
University of MarylandEarly Phase 1
Food and Drug Administration (FDA)Early Phase 1
University of OxfordN/A

See all RIVASTIGMINE clinical trials

Recent Litigation for RIVASTIGMINE

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District Court Litigation
Case NameDate
NOVARTIS PHARMACEUTICALS CORPORATION v. DR. REDDYS LABORATORIES, LTD.2015-11-06
Novartis Pharmaceuticals Corporation v. Amneal Pharmaceuticals LLC2015-11-05
Novartis Pharmaceuticals Corporation v. Dr. Reddy's Laboratories, Ltd.2015-11-05

See all RIVASTIGMINE litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2014-11-13
Noven Pharmaceuticals, Inc.2014-04-02

See all RIVASTIGMINE litigation

Generic filers with tentative approvals for RIVASTIGMINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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.

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
Paragraph IV (Patent) Challenges for RIVASTIGMINE
Tradename Dosage Ingredient NDA Submissiondate
EXELON FILM, EXTENDED RELEASE;TRANSDERMAL rivastigmine 022083 2013-01-22
EXELON FILM, EXTENDED RELEASE;TRANSDERMAL rivastigmine 022083 2011-04-27

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
Orchid Hlthcare RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-002 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-003 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-001 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-004 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Chartwell Rx RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 207797-003 Sep 28, 2017 AB RX No No   Start Trial   Start Trial   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 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   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RIVASTIGMINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0193926 SPC/GB98/041 United Kingdom   Start 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   Start Trial PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
0193926 C980031 Netherlands   Start 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Johnson and Johnson
Colorcon
Mallinckrodt
Boehringer Ingelheim

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