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PRAVASTATIN SODIUM Drug Profile

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When do Pravastatin Sodium patents expire, and what generic alternatives are available?

Pravastatin Sodium is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Cipla, Dr Reddys Labs Inc, Glenmark Generics, Hisun Pharm Hangzhou, Lupin Pharms, Mylan, Mylan Pharms Inc, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa. and is included in eighteen NDAs.

The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pravastatin Sodium

A generic version of PRAVASTATIN SODIUM was approved as pravastatin sodium by TEVA on April 24^th, 2006.

Summary for PRAVASTATIN SODIUM

US Patents:	0
Applicants:	18
NDAs:	18
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	23
Patent Applications:	4,627
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PRAVASTATIN SODIUM
Drug Sales Revenues:	Drug sales revenues for PRAVASTATIN SODIUM
DailyMed Link:	PRAVASTATIN SODIUM at DailyMed

See drug prices for PRAVASTATIN SODIUM

See drug sales revenues for PRAVASTATIN SODIUM

Recent Clinical Trials for PRAVASTATIN SODIUM

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 4
University of Thessaly	N/A
University of Southern California	Phase 2

See all PRAVASTATIN SODIUM clinical trials

Pharmacology for PRAVASTATIN SODIUM

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for PRAVASTATIN SODIUM

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

ATC Classes for PRAVASTATIN SODIUM

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for PRAVASTATIN SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
PRAVACHOL	TABLET;ORAL	pravastatin sodium	019898	2005-06-01

US Patents and Regulatory Information for PRAVASTATIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077013-002	Oct 23, 2006		DISCN	No	No
Glenmark Generics	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077987-004	Dec 28, 2007	AB	RX	No	No
Pliva Hrvatska Doo	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077730-002	Nov 21, 2006		DISCN	No	No
Watson Labs	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	076939-004	Oct 23, 2006	AB	RX	No	No
Mylan Pharms Inc	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	079187-002	May 27, 2010		DISCN	No	No
Pliva Hrvatska Doo	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077730-003	Nov 21, 2006		DISCN	No	No