LESCOL Drug Patent Profile

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

Lescol is a drug marketed by Novartis and Sandoz and is included in two NDAs.

The generic ingredient in LESCOL 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

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

Summary for LESCOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	11
Patent Applications:	6,055
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LESCOL
What excipients (inactive ingredients) are in LESCOL?	LESCOL excipients list
DailyMed Link:	LESCOL at DailyMed

See drug prices for LESCOL

Recent Clinical Trials for LESCOL

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

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

See all LESCOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LESCOL

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for LESCOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LESCOL	Capsules	fluvastatin sodium	20 mg and 40 mg	020261	1	2008-06-04

US Patents and Regulatory Information for LESCOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993		DISCN	Yes	No
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993		DISCN	Yes	No
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	AB	RX	Yes	Yes

Expired US Patents for LESCOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993

International Patents for LESCOL

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

Country	Patent Number	Title	Estimated Expiration
Finland	925615
Canada	2085037	COMPOSITIONS PHARMACEUTIQUES STABILISEES CONTENANT UN COMPOSE INHIBITEUR DE LA HMG-COA REDUCTASE (STABILIZED PHARMACEUTICAL COMPOSITIONS COMPRISING AN HMG-COA REDUCTASE INHIBITOR COMPOUND)
Greece	3032929
Romania	111542	COMPOZITIE FARMACEUTICA STABILIZATA (STABILIZED PHARMACEUTICAL COMPOSITION)
Israel	104041	Pharmaceutical compositions comprising an hmg-CoA reductase inhibitor compound and method for their preparation
Japan	H05246844
Hungary	0000790

Supplementary Protection Certificates for LESCOL

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