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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Covington
Johnson and Johnson
Cipla
Cantor Fitzgerald
Express Scripts
Harvard Business School
Novartis
US Army
Farmers Insurance

Generated: August 17, 2017

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Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate - Generic Drug Details

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

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

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate has four hundred and seventy-three patent family members in sixty countries.

There are sixteen drug master file entries for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. One supplier is listed for this compound.

Summary for Generic Name: emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Tradenames:1
Patents:12
Applicants:1
NDAs:1
Drug Master File Entries: see list16
Suppliers / Packagers: see list1
Clinical Trials: see list3,187
Drug Prices:see low prices
DailyMed Link:emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate at DailyMed

Expired Orange Book Patents for Generic Ingredient: emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: emtricitabine; rilpivirine hydrochloride; 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
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► Subscribe
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► 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; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Country Document Number Estimated Expiration
Israel173438► Subscribe
Ukraine75889► Subscribe
Norway2014032► Subscribe
South Korea20070053284► Subscribe
China100402539► 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; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0120010 00057Estonia► SubscribePRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011
1419152/01Switzerland► SubscribePRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: SWISSMEDIC 61548 26.02.2013
2016000024Germany► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2012 00019Denmark► Subscribe
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
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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Accenture
Queensland Health
Johnson and Johnson
Merck
Baxter
Healthtrust
US Army
Argus Health
Cantor Fitzgerald

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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