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, 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. Additional information is available in the individual branded drug profile pages.

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

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	32
Suppliers / Packagers:	10
Bulk Api Vendors:	73
Clinical Trials:	90
Patent Applications:	7,037
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for rivastigmine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rivastigmine
What excipients (inactive ingredients) are in rivastigmine?	rivastigmine excipients list
DailyMed Link:	rivastigmine at DailyMed

See drug prices for rivastigmine

Recent Clinical Trials for rivastigmine

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 2
Royal United Hospitals Bath NHS Foundation Trust	Phase 3
University of Bristol	Phase 3

See all rivastigmine clinical trials

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

Cholinesterase Inhibitors
Neuroprotective Agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Noveltech Inc	RIVASTIGMINE	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	206318-003	Mar 4, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Apotex Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	091072-002	May 16, 2013		DISCN	No	No	Start Trial	Start Trial				Start Trial
Aurobindo Pharma Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	204572-002	Mar 25, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Zydus Noveltech Inc	RIVASTIGMINE	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	206318-002	Mar 4, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Novartis	EXELON	rivastigmine tartrate	SOLUTION;ORAL	021025-001	Apr 21, 2000		DISCN	No	No	Start Trial	Start Trial				Start Trial
Sun Pharm	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077131-004	Oct 22, 2007	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

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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	022083-001	Jul 6, 2007	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
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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