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Serving 500+ biopharmaceutical companies globally:

Fuji
Cerilliant
Cantor Fitzgerald
Accenture
McKinsey
Teva
QuintilesIMS
Farmers Insurance
Julphar
Cipla

Generated: June 24, 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir alafenamide fumarate has two hundred and seventy-four patent family members in fifty-eight 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

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list16
Suppliers / Packagers: see list2
Clinical Trials: see list898
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, 2016RXYesYes6,642,245*PED► SubscribeY► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes7,803,788► Subscribe ► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes8,754,065► SubscribeYY ► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes5,914,331*PED► SubscribeY► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes9,296,769► 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, 20165,814,639*PED► 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
5,539,116 Method and compositions for the synthesis of BCH-189 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
5,728,575 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► 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
Bulgaria66037► Subscribe
New Zealand250842► Subscribe
South Africa200210271► Subscribe
Norway923014► Subscribe
Australia1437292► 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
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
2016009Lithuania► SubscribePRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
2016000024Germany► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
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
2016 00012Denmark► SubscribePRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Moodys
Argus Health
Farmers Insurance
AstraZeneca
Cerilliant
Citi
Johnson and Johnson
Cantor Fitzgerald
Merck

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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