LESCOL XL Drug Patent Profile

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

Lescol Xl is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in LESCOL XL is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lescol Xl

A generic version of LESCOL XL was approved as fluvastatin sodium by MYLAN PHARMS INC on April 11^th, 2012.

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Summary for LESCOL XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	11
Patent Applications:	3,769
Drug Prices:	Drug price information for LESCOL XL
What excipients (inactive ingredients) are in LESCOL XL?	LESCOL XL excipients list
DailyMed Link:	LESCOL XL at DailyMed

Drug patent expirations by year for LESCOL XL

Recent Clinical Trials for LESCOL XL

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

Sponsor	Phase
Amgen	Phase 4
Brigham and Women's Hospital	Phase 4
University of California, San Francisco	Phase 4

See all LESCOL XL clinical trials

Pharmacology for LESCOL XL

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Paragraph IV (Patent) Challenges for LESCOL XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LESCOL XL	Extended-release Tablets	fluvastatin sodium	80 mg	021192	1	2007-03-15

US Patents and Regulatory Information for LESCOL XL

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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
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	AB	RX	Yes	Yes	⤷ 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 LESCOL XL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	⤷ Sign Up	⤷ Sign Up
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	⤷ Sign Up	⤷ Sign Up
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LESCOL XL

See the table below for patents covering LESCOL XL around the world.

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Country	Patent Number	Title	Estimated Expiration
New Zealand	521441	Pharmaceutical compositions	⤷ Sign Up
Israel	104041	Pharmaceutical compositions comprising an hmg-CoA reductase inhibitor compound and method for their preparation	⤷ Sign Up
Singapore	160185	PHARMACEUTICAL COMPOSITIONS COMPRISING FLUVASTATIN	⤷ Sign Up
European Patent Office	0114027	ANALOGS OF MEVALOLACTONE AND DERIVATIVES THEREOF, PROCESSES FOR THEIR PRODUCTION, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE AS PHARMACEUTICALS	⤷ Sign Up
Spain	527428		⤷ Sign Up
South Korea	900009006		⤷ Sign Up
New Zealand	206338	L -(INDOL-2-YL)- B , W -DIHYDROXYALKANOATES AND PHARMACEUTICAL COMPOSITIONS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LESCOL XL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0114027	96C0022	Belgium	⤷ Sign Up	PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
0114027	SPC/GB93/173	United Kingdom	⤷ Sign Up	SPC/GB93/173: 20031122, EXPIRES: 20080822
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description