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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Farmers Insurance
Moodys
Express Scripts
Deloitte
Mallinckrodt
Citi
Teva
Medtronic

Generated: April 23, 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. Three suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
Summary for COMPLERA
Drug patent expirations by year for COMPLERA
Synonyms for COMPLERA
1436864-99-1
DQEFVRYFVZNIMK-FEDPJRJMSA-N
Emtricitabine / rilpivirine / tenofovir disoproxil fumarate
Emtricitabine mixture with rilpivirine and tenofovir disoproxil fumarate
Emtricitabine, rilpivirine, tenofovir mixture
Eviplera

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

Paragraph IV (Patent) Challenges for COMPLERA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 200 mg/25 mg/300 mg ➤ Subscribe 2015-05-20

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
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Try a Free Trial
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues ➤ Try a Free Trial
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Try a Free Trial
5,276,151 Method of synthesis of 1,3-dioxolane nucleosides ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for COMPLERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016044 Lithuania ➤ Try a Free Trial PRODUCT NAME: RILPIVIRINAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2015037 Lithuania ➤ Try a Free Trial PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128
178 Luxembourg ➤ Try a Free Trial 91178, EXPIRES: 20200221
2016045 Lithuania ➤ Try a Free Trial PRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Moodys
Colorcon
Mallinckrodt
Harvard Business School
Medtronic
Queensland Health
Teva
Boehringer Ingelheim

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