FLOLIPID Drug Patent Profile

Which patents cover Flolipid, and what generic alternatives are available?

Flolipid is a drug marketed by Tcg Fluent Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has twelve patent family members in twelve countries.

The generic ingredient in FLOLIPID is simvastatin. There are forty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flolipid

A generic version of FLOLIPID was approved as simvastatin by AUROBINDO PHARMA on December 20^th, 2006.

Summary for FLOLIPID

International Patents:	12
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FLOLIPID
What excipients (inactive ingredients) are in FLOLIPID?	FLOLIPID excipients list
DailyMed Link:	FLOLIPID at DailyMed

See drug prices for FLOLIPID

Pharmacology for FLOLIPID

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

Anatomical Therapeutic Chemical (ATC) Classes for FLOLIPID

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

US Patents and Regulatory Information for FLOLIPID

FLOLIPID is protected by two US patents.

Patents protecting FLOLIPID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tcg Fluent Pharma	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No			Y
Tcg Fluent Pharma	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes			Y
Tcg Fluent Pharma	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No			Y
Tcg Fluent Pharma	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes			Y

International Patents for FLOLIPID

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

Country	Patent Number	Title	Estimated Expiration
Poland	2018153
Spain	2385752
World Intellectual Property Organization (WIPO)	2007125339
Japan	2009534459
Portugal	2018153
Austria	E552825

Supplementary Protection Certificates for FLOLIPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	SPC/GB05/010	United Kingdom		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599	26/2005	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402