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 Pharms, 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:	16
NDAs:	18
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	97
Patent Applications:	7,121
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
Shahid Sadoughi University of Medical Sciences and Health Services	Phase 3
National Institute for Medical Research Development (NIMAD), Iran	Phase 3
McMaster University	Phase 3

See all rivastigmine clinical trials

Generic filers with tentative approvals for RIVASTIGMINE

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	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	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

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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
Watson Labs	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077129-001	Jan 8, 2008	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Apotex Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	091072-002	May 16, 2013		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sun Pharm	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077131-002	Oct 22, 2007	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	022083-005	Aug 31, 2012	See Plans and Pricing	See Plans and Pricing
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	See Plans and Pricing	See Plans and Pricing
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for rivastigmine

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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