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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Julphar
Cipla
Citi
UBS
Farmers Insurance
Fish and Richardson
Express Scripts
Daiichi Sankyo

Generated: August 16, 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.

Drug patent expirations by year for ODEFSEY
Generic Entry Opportunity Date for ODEFSEY
Generic Entry Date for ODEFSEY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
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
5,728,575 Method of resolution of 1,3-oxathiolane nucleoside enantiomers ➤ 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
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ODEFSEY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00056 Denmark ➤ Sign Up PRODUCT NAME: CERTIFIKAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2015038 Lithuania ➤ Sign Up PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
0150041 00168 Estonia ➤ Sign Up PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Citi
Argus Health
Accenture
Medtronic
QuintilesIMS
Healthtrust
Mallinckrodt

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.