RIVASTIGMINE TARTRATE - Generic Drug Details

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

Rivastigmine tartrate is the generic ingredient in two branded drugs marketed by 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 twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for rivastigmine tartrate. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for RIVASTIGMINE TARTRATE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	2
Patent Applications:	4,357
Drug Prices:	Drug price trends for RIVASTIGMINE TARTRATE
What excipients (inactive ingredients) are in RIVASTIGMINE TARTRATE?	RIVASTIGMINE TARTRATE excipients list
DailyMed Link:	RIVASTIGMINE TARTRATE at DailyMed

See drug prices for RIVASTIGMINE TARTRATE

Recent Clinical Trials for RIVASTIGMINE TARTRATE

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

Sponsor	Phase
Taishoff Family Foundation	Phase 1/Phase 2
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Phase 1/Phase 2
Duke University	Phase 1/Phase 2

See all RIVASTIGMINE TARTRATE clinical trials

Generic filers with tentative approvals for RIVASTIGMINE TARTRATE

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 TARTRATE

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RIVASTIGMINE TARTRATE

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

Paragraph IV (Patent) Challenges for RIVASTIGMINE TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXELON	Oral Solution	rivastigmine tartrate	2 mg/mL	021025	1	2004-11-05
EXELON	Capsules	rivastigmine tartrate	1.5 mg, 3 mg, 4.5 mg and 6 mg	020823	3	2004-04-21

US Patents and Regulatory Information for RIVASTIGMINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	091072-003	May 16, 2013		DISCN	No	No
Sun Pharm	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077131-002	Oct 22, 2007	AB	RX	No	No
Macleods Pharms Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	203148-001	Aug 22, 2014	AB	RX	No	No
Dr Reddys Labs Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077130-004	Oct 31, 2007	AB	RX	No	Yes
Dr Reddys Labs Inc	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077130-003	Oct 31, 2007	AB	RX	No	No
Cadila Pharms Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	203844-001	Feb 13, 2017	AB	RX	No	No

Expired US Patents for RIVASTIGMINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-003	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-004	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-005	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	SOLUTION;ORAL	021025-001	Apr 21, 2000