PRAVACHOL Drug Patent Profile

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When do Pravachol patents expire, and when can generic versions of Pravachol launch?

Pravachol is a drug marketed by Bristol Myers Squibb and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pravachol

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

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Summary for PRAVACHOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	28
Patent Applications:	6,634
Drug Prices:	Drug price information for PRAVACHOL
Drug Sales Revenues:	Drug sales revenues for PRAVACHOL
What excipients (inactive ingredients) are in PRAVACHOL?	PRAVACHOL excipients list
DailyMed Link:	PRAVACHOL at DailyMed

Drug patent expirations by year for PRAVACHOL

Recent Clinical Trials for PRAVACHOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amgen	Phase 4
Brigham and Women's Hospital	Phase 4
Mayo Clinic	Phase 2

See all PRAVACHOL clinical trials

Paragraph IV (Patent) Challenges for PRAVACHOL

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 PRAVACHOL

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Glossary

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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
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 PRAVACHOL

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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	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PRAVACHOL

See the table below for patents covering PRAVACHOL around the world.

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Country	Patent Number	Title	Estimated Expiration
Denmark	173862		⤷ Sign Up
Finland	811762		⤷ Sign Up
Hong Kong	40093	PHARMACEUTICAL COMPOSITIONS HAVING GOOD STABILITY	⤷ Sign Up
Canada	1150170	DERIVES DE ML-236B ET LEUR PREPARATION (ML-236B DERIVATIVES AND THEIR PREPARATION)	⤷ Sign Up
European Patent Office	0738512	Emploi d'un ibhibiteur du HMG CoA réductase pour empêcher deuxième crise cardiaque (Use of a HMG CoA reductase inhibitor to prevent a second heart attack)	⤷ Sign Up
Australia	715181		⤷ Sign Up
Japan	S57108039	ML-236B DERIVATIVE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for PRAVACHOL

Recent Clinical Trials for PRAVACHOL

Paragraph IV (Patent) Challenges for PRAVACHOL

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