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, Beijing, Norvium Bioscience, Teva Pharms Usa, and Sandoz, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for fluvastatin sodium

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	5
Patent Applications:	6,096
Drug Prices:	Drug price trends for fluvastatin sodium
What excipients (inactive ingredients) are in fluvastatin sodium?	fluvastatin sodium excipients list
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
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de 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
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for fluvastatin sodium

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

Paragraph IV (Patent) Challenges for FLUVASTATIN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LESCOL	Capsules	fluvastatin sodium	20 mg and 40 mg	020261	1	2008-06-04
LESCOL XL	Extended-release Tablets	fluvastatin sodium	80 mg	021192	1	2007-03-15

US Patents and Regulatory Information for fluvastatin sodium

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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
Teva Pharms Usa	FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	079011-001	Jan 27, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	202458-001	Sep 11, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	090595-002	Apr 11, 2012	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	078407-001	Jun 12, 2012	AB	RX	No	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 fluvastatin sodium

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

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