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Fluvastatin sodium - Generic Drug Details

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What are the generic drug sources for fluvastatin sodium and what is the scope of patent protection?

Fluvastatin sodium is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc, Teva Pharms, Novartis, Mylan, and Teva Pharms Usa, and is included in six NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fluvastatin sodium has twenty-eight patent family members in nineteen countries.

There are eleven drug master file entries for fluvastatin sodium. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fluvastatin sodium

International Patents:	28
US Patents:	1
Tradenames:	3
Applicants:	5
NDAs:	6
Drug Master File Entries:	11
Suppliers / Packagers:	4
Bulk Api Vendors:	97
Clinical Trials:	5
Patent Applications:	5,324
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fluvastatin sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluvastatin sodium
DailyMed Link:	fluvastatin sodium at DailyMed

See drug prices for fluvastatin sodium

Recent Clinical Trials for fluvastatin sodium

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

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4
Novartis Pharmaceuticals	Phase 4

See all fluvastatin sodium clinical trials

Generic filers with tentative approvals for FLUVASTATIN SODIUM

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fluvastatin sodium

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

Paragraph IV (Patent) Challenges for FLUVASTATIN SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
LESCOL	CAPSULE;ORAL	fluvastatin sodium	020261	2008-06-04
LESCOL XL	TABLET, EXTENDED RELEASE;ORAL	fluvastatin sodium	021192	2007-03-15

US Patents and Regulatory Information for fluvastatin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	202458-001	Sep 11, 2015		DISCN	No	No
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993		DISCN	Yes	No
Teva Pharms	FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	078407-001	Jun 12, 2012	AB	RX	No	No

Expired US Patents for fluvastatin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993
Novartis	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000

International Patents for fluvastatin sodium

Country	Patent Number	Estimated Expiration
Hungary	0300541
Mexico	PA02010136
New Zealand	521441

Supplementary Protection Certificates for fluvastatin sodium

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