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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Teva
Covington
Cantor Fitzgerald
Deloitte
Julphar
Accenture
Citi
Chubb

Generated: June 25, 2018

DrugPatentWatch Database Preview

ODEFSEY Drug Profile

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

Odefsey is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has five hundred and thirteen patent family members in sixty countries.

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

US Patents and Regulatory Information for ODEFSEY

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up 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 ODEFSEY

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 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ODEFSEY

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
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers ➤ Sign Up
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ODEFSEY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0150040 00167 Estonia ➤ Sign Up PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
12/017 Ireland ➤ Sign Up PRODUCT NAME: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT THEREOF, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
2016 00063 Denmark ➤ Sign Up PRODUCT NAME: RILPIVIRINHYDROCHLORID OG 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:

Argus Health
Daiichi Sankyo
Covington
Harvard Business School
AstraZeneca
Teva
Farmers Insurance
Fish and Richardson
Merck

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