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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chubb
US Army
Express Scripts
Queensland Health
Boehringer Ingelheim
Teva
Baxter
Federal Trade Commission

Generated: May 21, 2018

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 thirteen patent family members in sixty countries.

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

US Patents and Regulatory Information 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 Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for 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;ORAL 208351-001 Mar 1, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,468,436 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Try a Free Trial
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
8,841,310 Combinations of a pyrimidine containing NNRTI with RT inhibitors ➤ Try a Free Trial
7,053,100 Therapeutic nucleosides ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2012000038 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
C0032 France ➤ Try a Free Trial PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
2016 00012 Denmark ➤ Try a Free Trial PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Covington
US Army
Dow
Fish and Richardson
Fuji
Citi
Deloitte

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