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Last Updated: March 19, 2024

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, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Generics, Hisun Pharm Hangzhou, 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 fifteen drug master file entries for pravastatin sodium. Thirty-five 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

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Generic filers with tentative approvals for PRAVASTATIN SODIUM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial80MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial40MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial20MGTABLET;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 Strength NDA ANDAs Submitted Submissiondate
PRAVACHOL Tablets pravastatin sodium 30 mg 019898 1 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
Teva PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076056-003 Apr 24, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077987-004 Dec 28, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077917-004 Jan 8, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 019898-003 Oct 31, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-002 Oct 31, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-008 Dec 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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