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Rivastigmine - Generic Drug Details
What are the generic drug sources for rivastigmine and what is the scope of freedom to operate?
Rivastigmine
is the generic ingredient in three branded drugs marketed by Novartis, Alvogen, Amneal Pharms, Breckenridge, 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 eighteen 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. Ten suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for rivastigmine
| International Patents: | 37 |
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 16 |
| NDAs: | 18 |
| Drug Master File Entries: | 32 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 68 |
| Clinical Trials: | 88 |
| Patent Applications: | 6,127 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for rivastigmine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for rivastigmine |
| DailyMed Link: | rivastigmine at DailyMed |
Recent Clinical Trials for rivastigmine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Royal United Hospitals Bath NHS Foundation Trust | Phase 3 |
| University of Bristol | Phase 3 |
| Ain Shams University | Phase 1/Phase 2 |
Recent Litigation for rivastigmine
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NOVARTIS PHARMACEUTICALS CORPORATION v. DR. REDDYS LABORATORIES, LTD. | 2015-11-06 |
| Novartis Pharmaceuticals Corporation v. Amneal Pharmaceuticals LLC | 2015-11-05 |
| Novartis Pharmaceuticals Corporation v. Dr. Reddy's Laboratories, Ltd. | 2015-11-05 |
See all rivastigmine litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2014-11-13 |
| Noven Pharmaceuticals, Inc. | 2014-04-02 |
Generic filers with tentative approvals for RIVASTIGMINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 2MG/ML | SOLUTION; 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
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 207308-002 | Jan 8, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Alvogen | RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 204403-002 | Sep 3, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-005 | Apr 21, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan Technologies | RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 205622-003 | Jun 20, 2018 | 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 | 022083-005 | Aug 31, 2012 | 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 | 022083-001 | Jul 6, 2007 | Start Trial | Start Trial |
| Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-002 | Jul 6, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rivastigmine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69902875 | Start Trial |
| China | 1288375 | Start Trial |
| Hong Kong | 1034036 | Start Trial |
| New Zealand | 505650 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for rivastigmine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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