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Last Updated: August 17, 2022

FLOLIPID Drug Patent 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-four 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 20th, 2006.

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Summary for FLOLIPID
International Patents:12
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
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
Drug patent expirations by year for FLOLIPID
Drug Prices for FLOLIPID

See drug prices for FLOLIPID

US Patents and Regulatory Information for FLOLIPID

FLOLIPID is protected by two US patents.

Patents protecting FLOLIPID

Liquid oral simvastatin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liquid oral simvastatin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

International Patents for FLOLIPID

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

Country Patent Number Title Estimated Expiration
Japan 2009534459 See Plans and Pricing
European Patent Office 2018153 COMPOSITIONS ORALES LIQUIDES (LIQUID ORAL COMPOSITIONS) See Plans and Pricing
Austria 552825 See Plans and Pricing
China 101431982 Liquid oral compositions See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007125339 See Plans and Pricing
Cyprus 1112917 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLOLIPID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 SPC/GB05/010 United Kingdom See Plans and Pricing 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 26/2005 Austria See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 122004000026 Germany See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.