RIVASTIGMINE - Generic Drug Details

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 Sandoz, Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Pharms, Novartis, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, 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:	17
NDAs:	18
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	101
Patent Applications:	6,959
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
NeuroSense Therapeutics Ltd.	Phase 2
Luye Pharma Group Ltd.	Phase 1
St. Antonius Hospital	Phase 4

See all RIVASTIGMINE clinical trials

Generic filers with tentative approvals for RIVASTIGMINE

Applicant	Application No.	Strength	Dosage Form
		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

Anatomical Therapeutic Chemical (ATC) Classes for RIVASTIGMINE

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RIVASTIGMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXELON	Transdermal System Extended-release	rivastigmine	13.3 mg/24 hr	022083	1	2013-01-22
EXELON	Transdermal System Extended-release	rivastigmine	4.6 mg/24 hr and 9.5 mg/24 hr	022083	1	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
Breckenridge	RIVASTIGMINE	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	209063-002	Nov 26, 2019	AB	RX	No	No
Dr Reddys Labs Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077130-004	Oct 31, 2007	AB	RX	No	Yes
Cadila Pharms Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	203844-004	Feb 13, 2017	AB	RX	No	No
Macleods Pharms Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	203148-001	Aug 22, 2014	AB	RX	No	No
Apotex Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	091072-003	May 16, 2013		DISCN	No	No
Apotex Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	091072-002	May 16, 2013		DISCN	No	No
Apotex Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	091072-001	May 16, 2013		DISCN	No	No

Expired US Patents for RIVASTIGMINE

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

EU/EMA Drug Approvals for RIVASTIGMINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Actavis Group PTC ehf	Rivastigmine Actavis	rivastigmine	EMEA/H/C/002036 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	yes	no	no	2011-06-16
Krka, d.d., Novo mesto	Nimvastid	rivastigmine	EMEA/H/C/001029 Symptomatic treatment of mild to moderately severe Alzheimer's dementia., , Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.,	Authorised	yes	no	no	2009-05-11
1 A Pharma GmbH	Rivastigmine 1 A Pharma	rivastigmine	EMEA/H/C/001181 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	no	no	no	2009-12-11
Novartis Europharm Limited	Exelon	rivastigmine	EMEA/H/C/000169 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	no	no	no	1998-05-11
Novartis Europharm Limited	Prometax	rivastigmine	EMEA/H/C/000255 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	no	no	no	1998-12-03
Sandoz GmbH	Rivastigmine Sandoz	rivastigmine	EMEA/H/C/001183 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	no	no	no	2009-12-10
Hexal AG	Rivastigmine Hexal	rivastigmine	EMEA/H/C/001182 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	no	no	no	2009-12-11