You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Mallinckrodt
AstraZeneca
Dow
Boehringer Ingelheim

Last Updated: March 8, 2021

DrugPatentWatch Database Preview

Pravastatin sodium - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

See drug prices for pravastatin sodium

Drug Sales Revenue Trends for pravastatin sodium

See drug sales revenues for pravastatin sodium

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
  Start Trial  Start Trial80MGTABLET;ORAL
  Start Trial  Start Trial40MGTABLET;ORAL
  Start Trial  Start 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 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
Hisun Pharm Hangzhou PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 206061-002 Nov 23, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Generics PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077987-001 May 11, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Inc PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076714-001 Oct 23, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Apnar Pharma Lp PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077491-004 Oct 23, 2006 AB RX No No   Start Trial   Start Trial   Start 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 019898-008 Dec 18, 2001   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-004 Mar 22, 1993   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-004 Mar 22, 1993   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-002 Oct 31, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
McKesson
Dow
Colorcon
Harvard Business School

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.