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Serving leading biopharmaceutical companies globally:

Covington
Healthtrust
McKinsey
Farmers Insurance
Chinese Patent Office
US Department of Justice
Medtronic
Express Scripts
Colorcon
QuintilesIMS

Generated: February 19, 2018

DrugPatentWatch Database Preview

COMPLERA Drug Profile

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When do Complera patents expire, and what generic alternatives are available?

Complera is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and thirty-six patent family members in fifty-one countries.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.

US Patents and Regulatory Information for COMPLERA

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 COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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 COMPLERA

Paragraph IV (Patent) Challenges for COMPLERA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 200 mg/25 mg/300 mg ➤ Subscribe 5/20/2015

Non-Orange Book US Patents for COMPLERA

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 ➤ Sign Up
7,053,100 Therapeutic nucleosides ➤ Sign Up
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues ➤ Sign Up
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Sign Up
9,580,392 HIV replication inhibiting pyrimidines ➤ Sign Up
7,160,999 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Sign Up
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane ➤ Sign Up
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for COMPLERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000109 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2012000038 Germany ➤ Sign Up 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
2016000111 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2005 00032 Denmark ➤ Sign Up
008 Luxembourg ➤ Sign Up 92008, EXPIRES: 20261128
2004 Austria ➤ Sign Up PRODUCT 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
6 Finland ➤ Sign Up
1419152/01 Switzerland ➤ Sign Up PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: SWISSMEDIC 61548 26.02.2013
0120010 00057 Estonia ➤ Sign Up PRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011
2016 00066 Denmark ➤ Sign Up PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Harvard Business School
Chinese Patent Office
Cantor Fitzgerald
Julphar
Chubb
Fuji
Healthtrust

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