PRAVASTATIN SODIUM - Generic Drug Details

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What are the generic drug sources for pravastatin sodium and what is the scope of freedom to operate?

Pravastatin sodium is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Norvium Bioscience, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for pravastatin sodium. Forty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for PRAVASTATIN SODIUM

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	30
Patent Applications:	7,600
Drug Prices:	Drug price trends for PRAVASTATIN SODIUM
Drug Sales Revenues:	Drug sales revenues for PRAVASTATIN SODIUM
What excipients (inactive ingredients) are in PRAVASTATIN SODIUM?	PRAVASTATIN SODIUM excipients list
DailyMed Link:	PRAVASTATIN SODIUM at DailyMed

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Drug Sales Revenue Trends for PRAVASTATIN SODIUM

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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

Generic filers with tentative approvals for PRAVASTATIN SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	80MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	40MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	20MG	TABLET;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 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

Anatomical Therapeutic Chemical (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	Strength	NDA	ANDAs Submitted	Submissiondate
PRAVACHOL	Tablets	pravastatin sodium	30 mg	019898	1	2005-06-01

US Patents and Regulatory Information for PRAVASTATIN SODIUM

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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
Pliva Hrvatska Doo	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077730-003	Nov 21, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077917-003	Jan 8, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	203367-004	Feb 2, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	079187-002	May 27, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	207068-003	Nov 17, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	203367-001	Feb 2, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 PRAVASTATIN SODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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