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Generated: December 18, 2017

DrugPatentWatch Database Preview

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 five hundred and three patent family members in sixty countries and eighty-one supplementary protection certificates in thirteen countries.

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

Summary for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY► Subscribe
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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 IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;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
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,700,937 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
5,892,025 Method of resolution and antiviral activity 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
5,210,085 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
7,638,522Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino] benzonitrile► Subscribe
7,160,999Method of resolution and antiviral activity 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
5,728,575 Method of resolution 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
China100402539► Subscribe
Denmark1419152► Subscribe
China100396785► Subscribe
Hong Kong1026419► Subscribe
Canada2481078► Subscribe
Hungary9302377► Subscribe
Romania119365► Subscribe
JapanH06505725► Subscribe
Mexico2007002595► Subscribe
World Intellectual Property Organization (WIPO)2005021001► 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
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
854Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL
2 5010-2012Slovakia► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
073Luxembourg► Subscribe91073, EXPIRES: 20160131
2016042Lithuania► SubscribePRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2015000087Germany► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
4 5022-2015Slovakia► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2015038Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 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
0120012 00058Estonia► SubscribePRODUCT NAME: EVIPLERA - EMTRITSITABIIN/RILPIVIRIIN (HUEDRO-;REG NO/DATE: C(2011)8956 FINAL 28.11.2011
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
Dow
Fuji
QuintilesIMS
Farmers Insurance
UBS
Harvard Business School
Queensland Health
Covington

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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