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Last Updated: December 2, 2022

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, 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 fifteen 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

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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
See Plans and PricingSee Plans and Pricing20MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing80MGTABLET;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 076056-002 Apr 24, 2006 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apnar Pharma Lp PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077491-001 Feb 11, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076341-003 Oct 23, 2006 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 019898-004 Mar 22, 1993 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-003 Oct 31, 1991 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-003 Oct 31, 1991 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.