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Serving leading biopharmaceutical companies globally:

Citi
McKinsey
Mallinckrodt
Deloitte
Cerilliant
Baxter
Novartis
Moodys
Argus Health
Queensland Health

Generated: December 12, 2017

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Choline fenofibrate - Generic Drug Details

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What are the generic drug sources for choline fenofibrate and what is the scope of choline fenofibrate freedom to operate?

Choline fenofibrate
is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, and Abbvie, and is included in seven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Choline fenofibrate has nineteen patent family members in eleven countries and two supplementary protection certificates in two countries.

There are ninety-nine drug master file entries for choline fenofibrate. Eleven suppliers are listed for this compound.

Pharmacology for choline fenofibrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Anchen PharmsFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL201573-001Jul 18, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis ElizabethFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL200920-002Oct 7, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lupin LtdFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL200750-001Dec 4, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Alembic Pharms LtdFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL208705-001May 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieTRILIPIXcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL022224-001Dec 15, 2008ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Pharms IncFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL200913-002Mar 25, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis ElizabethFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL200920-001Oct 7, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieTRILIPIXcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL022224-002Dec 15, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Alembic Pharms LtdFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL208705-002May 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL200264-002Sep 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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International Patent Family for Ingredient: choline fenofibrate

Country Document Number Estimated Expiration
China101480384► Subscribe
Australia2003290060► Subscribe
Australia2010249244► Subscribe
European Patent Office1832285► Subscribe
European Patent Office1829541► Subscribe
MexicoPA05005736► Subscribe
Austria359777► Subscribe
World Intellectual Property Organization (WIPO)2004054568► Subscribe
Spain2286486► Subscribe
Russian Federation2008149770► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CHOLINE FENOFIBRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017 00030Denmark► SubscribePRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
C0009Belgium► SubscribePRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
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Serving leading biopharmaceutical companies globally:

Citi
Cipla
US Army
Dow
Healthtrust
Fuji
Harvard Business School
Chinese Patent Office
Accenture
Queensland Health

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 verifification 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.

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