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Last Updated: June 22, 2021

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Pravastatin sodium - Generic Drug Details

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What are the generic 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 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 nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for pravastatin sodium. Thirty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for pravastatin sodium

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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

SponsorPhase
University of Maryland, BaltimorePhase 4
University of ThessalyN/A
University of Southern CaliforniaPhase 2

See all pravastatin sodium clinical trials

Generic filers with tentative approvals for PRAVASTATIN SODIUM
Applicant Application No. Strength Dosage Form
  Try Before You Buy  Try Before You Buy80MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy40MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy20MGTABLET;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
Medical Subject Heading (MeSH) Categories for pravastatin sodium
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
Biocon Pharma PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 209869-002 Apr 13, 2018 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Apnar Pharma Lp PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077491-003 Oct 23, 2006 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Lupin Pharms PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077917-002 Jan 8, 2008 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-002 Oct 31, 1991   Try Before You Buy   Try Before You Buy
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-008 Dec 18, 2001   Try Before You Buy   Try Before You Buy
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-003 Oct 31, 1991   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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