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Last Updated: August 11, 2020

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FLOLIPID Drug Profile

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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-eight suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

US ANDA Litigation and Generic Entry Outlook for Flolipid

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

  Start Trial

Summary for FLOLIPID
Drug patent expirations by year for FLOLIPID
Drug Prices for FLOLIPID

See drug prices for FLOLIPID

Pharmacology for FLOLIPID

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

Supplementary Protection Certificates for FLOLIPID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 122004000026 Germany   Start Trial 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 05C0040 France   Start Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 C300172 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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