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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Julphar
Deloitte
Fuji
Medtronic
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Citi
Chubb
Covington
Queensland Health

Generated: November 23, 2017

DrugPatentWatch Database Preview

COMPLERA Drug Profile

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What is the patent landscape for Complera, and what generic Complera 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 and eighty-five supplementary protection certificates in fourteen countries.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
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;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: COMPLERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for COMPLERA

Drugname Dosage Strength RLD Submissiondate
emtricitabine, rilpivirine, and tenofovir disoproxil fumarateTablets200 mg/25 mg/300 mgComplera5/20/2015

Non-Orange Book Patents for Tradename: 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
6,812,233 Therapeutic nucleosides► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► Subscribe
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,204,466 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
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
9,580,392HIV replication inhibiting pyrimidines► 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 Tradename: COMPLERA

Country Document Number Estimated Expiration
Hong Kong1051360► Subscribe
European Patent Office0872237► Subscribe
Japan4173202► Subscribe
Slovenia1789139► Subscribe
Japan2011016847► Subscribe
Australia756793► Subscribe
BrazilPI0406760► Subscribe
Japan4912309► Subscribe
World Intellectual Property Organization (WIPO)0164656► Subscribe
Norway339788► 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: COMPLERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2015Austria► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2015000088Germany► 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, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
5 5007-2012Slovakia► SubscribePRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
855Luxembourg► 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 , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
2012000035Germany► SubscribePRODUCT NAME: RILPIVIRIN UND DESSEN STEREOCHEMISCH ISOMERE FORMEN, SOWIE DESSEN PHARMAZEUTISCH UNBEDENKLICHE ADDITIONSSALZE, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
2016 00066Denmark► SubscribePRODUCT 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
2015000085Germany► 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 EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
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
433Luxembourg► Subscribe91433, EXPIRES: 20220725
2008 00023Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Farmers Insurance
Chubb
Healthtrust
UBS
Moodys
Mallinckrodt
Accenture
Deloitte
Julphar

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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