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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Argus Health
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

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What are the generic drug sources for emtricitabine; tenofovir alafenamide fumarate and what is the scope of emtricitabine; tenofovir alafenamide fumarate patent protection?

Emtricitabine; tenofovir alafenamide fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir alafenamide fumarate has two hundred and ninety-five patent family members in fifty-eight countries and twenty-one supplementary protection certificates in nine countries.

There are sixteen drug master file entries for emtricitabine; tenofovir alafenamide fumarate. Two suppliers are listed for this compound.

Summary for emtricitabine; tenofovir alafenamide fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: emtricitabine; tenofovir alafenamide fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: emtricitabine; tenofovir alafenamide fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
7,053,100Therapeutic nucleosides► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: emtricitabine; tenofovir alafenamide fumarate

Country Document Number Estimated Expiration
New Zealand250842► Subscribe
South Korea20140054068► Subscribe
TaiwanI516499► Subscribe
Australia2010201878► Subscribe
Hong Kong1054238► Subscribe
CroatiaP20161696► Subscribe
New Zealand620421► Subscribe
Israel100965► Subscribe
Mexico9200747► Subscribe
European Patent Office0984013► 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: EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0803Netherlands► SubscribePRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
0852Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
0851Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2016 00012Denmark► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
2016009,C1301519Lithuania► SubscribePRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
C/GB04/016United Kingdom► SubscribePRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
0513200/01Switzerland► SubscribePRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
2016000024Germany► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
C0071France► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0781Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Teva
Colorcon
UBS
Accenture
Citi
Harvard Business School
Baxter
Express Scripts

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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