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Generated: October 17, 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 Generic Name: emtricitabine; tenofovir alafenamide fumarate

US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list16
Suppliers / Packagers: see list2
Clinical Trials: see list914
Drug Prices:see low prices
DailyMed Link:emtricitabine; tenofovir alafenamide fumarate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► 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 Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;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
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► Subscribe
7,160,999Method 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
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► Subscribe
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues► 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
World Intellectual Property Organization (WIPO)9214729► Subscribe
Hungary211344► Subscribe
World Intellectual Property Organization (WIPO)9214743► Subscribe
Norway923014► Subscribe
Hong Kong1014664► Subscribe
China1109108► Subscribe
Japan3844978► Subscribe
MexicoPA03000587► Subscribe
Japan2007246536► Subscribe
TaiwanI516499► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00012Denmark► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
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
2016000024Germany► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C0032France► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
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
C0013France► SubscribePRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
073Luxembourg► Subscribe91073, EXPIRES: 20160131
2004Austria► SubscribePRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
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Serving leading biopharmaceutical companies globally:

Queensland Health
Deloitte
Boehringer Ingelheim
Healthtrust
Accenture
Citi
McKesson
Federal Trade Commission
Harvard Business School
UBS

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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