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Last Updated: June 6, 2020

DrugPatentWatch Database Preview

PRAVASTATIN SODIUM Drug Profile


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When do Pravastatin Sodium patents expire, and what generic alternatives are available?

Pravastatin Sodium is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, 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 eighteen NDAs.

The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Pravastatin Sodium

A generic version of PRAVASTATIN SODIUM was approved as pravastatin sodium by TEVA on April 24th, 2006.

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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
Mylan PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077013-002 Oct 23, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077987-004 Dec 28, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva Hrvatska Doo PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077730-002 Nov 21, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076939-004 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

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Serving leading biopharmaceutical companies globally:

Merck
Dow
Boehringer Ingelheim
Express Scripts
Mallinckrodt
Johnson and Johnson

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