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Serving 500+ biopharmaceutical companies globally:

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Mallinckrodt
US Army
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Generated: June 24, 2017

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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 pravastatin sodium patent protection?

Pravastatin sodium
is the generic ingredient in two branded drugs marketed by Cipla Ltd, Mylan, Dr Reddys Labs Inc, Lupin Pharms, Pliva Hrvatska Doo, Watson Labs, Apotex Inc, Ranbaxy Labs Ltd, Zydus Pharms Usa, Teva, Aurobindo Pharma Ltd, Accord Hlthcare, Glenmark Generics, Mylan Pharms Inc, Sandoz, Teva Pharms, and Bristol Myers Squibb, and is included in eighteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: pravastatin sodium

Tradenames:2
Patents:1
Applicants:17
NDAs:18
Drug Master File Entries: see list16
Suppliers / Packagers: see list48
Bulk Api Vendors: see list74
Clinical Trials: see list2,466
Patent Applications: see list7,183
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pravastatin sodium at DailyMed

Pharmacology for Ingredient: pravastatin sodium

Tentative approvals for PRAVASTATIN SODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe10MGTABLET;ORAL
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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;ORAL077013-003Oct 23, 2006DISCNNoNo► Subscribe► Subscribe
Dr Reddys Labs Inc
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL076714-003Oct 23, 2006ABRXNoNo► Subscribe► Subscribe
Apotex Inc
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL076341-004Dec 28, 2007ABRXNoNo► Subscribe► Subscribe
Pliva Hrvatska Doo
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL077730-003Nov 21, 2006DISCNNoNo► Subscribe► Subscribe
Lupin Pharms
PRAVASTATIN SODIUM
pravastatin sodium
TABLET;ORAL077917-004Jan 8, 2008ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pravastatin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-002Oct 31, 19915,622,985*PED► Subscribe
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-008Dec 18, 20015,180,589*PED► Subscribe
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-003Oct 31, 19915,030,447*PED► Subscribe
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-003Oct 31, 19915,180,589*PED► Subscribe
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-002Oct 31, 19914,346,227*PED► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Covington
Medtronic
Johnson and Johnson
Merck
Accenture
US Army
McKesson
US Department of Justice
Chubb

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 verifification 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.

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