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Last Updated: June 5, 2024

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ODEFSEY Drug Patent Profile


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When do Odefsey patents expire, and when can generic versions of Odefsey launch?

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

This drug has three hundred and thirty-one patent family members in fifty-seven countries.

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

DrugPatentWatch® Generic Entry Outlook for Odefsey

Odefsey was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 15, 2033. This may change due to patent challenges or generic licensing.

There have been nineteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ODEFSEY
International Patents:331
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Formulation / Manufacturing:see details
Drug Prices: Drug price information for ODEFSEY
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for ODEFSEY
What excipients (inactive ingredients) are in ODEFSEY?ODEFSEY excipients list
DailyMed Link:ODEFSEY at DailyMed
Drug patent expirations by year for ODEFSEY
Drug Prices for ODEFSEY

See drug prices for ODEFSEY

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ODEFSEY
Generic Entry Date for ODEFSEY*:
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Constraining patent/regulatory exclusivity:
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NDA:
208351
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.

Pharmacology for ODEFSEY
Drug ClassHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of ActionNon-Nucleoside Reverse Transcriptase Inhibitors
Nucleoside Reverse Transcriptase Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for ODEFSEY
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J05AG Non-nucleoside reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
Paragraph IV (Patent) Challenges for ODEFSEY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ODEFSEY Tablets emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate 200 mg/25 mg/ 25 mg 208351 3 2019-11-05

US Patents and Regulatory Information for ODEFSEY

ODEFSEY is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ODEFSEY is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ODEFSEY

HIV inhibiting pyrimidines derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Glossary
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 ⤷  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
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
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
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
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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International Patents for ODEFSEY

When does loss-of-exclusivity occur for ODEFSEY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 39
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 7546
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 12296622
Estimated Expiration: ⤷  Sign Up

Patent: 14271320
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014003420
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 45553
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14000370
Estimated Expiration: ⤷  Sign Up

China

Patent: 3732594
Estimated Expiration: ⤷  Sign Up

Patent: 0343135
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 80063
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 140072
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0161696
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 18385
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 14013206
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 7768
Estimated Expiration: ⤷  Sign Up

Patent: 1490208
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Patent: 70088
Estimated Expiration: ⤷  Sign Up

Patent: 31832
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 99026
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 31253
Estimated Expiration: ⤷  Sign Up

India

Patent: 12DEN2014
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0949
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 51275
Estimated Expiration: ⤷  Sign Up

Patent: 56537
Estimated Expiration: ⤷  Sign Up

Patent: 80162
Estimated Expiration: ⤷  Sign Up

Patent: 14528924
Estimated Expiration: ⤷  Sign Up

Patent: 15038149
Estimated Expiration: ⤷  Sign Up

Patent: 16169228
Estimated Expiration: ⤷  Sign Up

Patent: 18065870
Estimated Expiration: ⤷  Sign Up

Patent: 20040972
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6627
Estimated Expiration: ⤷  Sign Up

Patent: 14001549
Estimated Expiration: ⤷  Sign Up

Moldova, Republic of

Patent: 08
Estimated Expiration: ⤷  Sign Up

Patent: 140011
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 612
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 350
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0421
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 141328
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 44810
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01600476
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 353
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 14011548
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 44810
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1400582
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1612642
Estimated Expiration: ⤷  Sign Up

Patent: 140054068
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 08871
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 16499
Estimated Expiration: ⤷  Sign Up

Patent: 1321396
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 5311
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 262
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ODEFSEY around the world.

Country Patent Number Title Estimated Expiration
Japan 4838396 ⤷  Sign Up
Uruguay 34262 HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA, SUS COMPOSICIONES, MÉTODO DE PREPARACIÓN, MÉTODOS PARA TRATAR INFECCIONES VIRALES Y SU USO PARA PREPARAR MEDI CAMENTOS ⤷  Sign Up
Hungary 0401346 HIV-gátló pirimidinszármazékok, eljárás az előállításukra és ezeket tartalmazó gyógyszerkészítmények (HIV INHIBITING PYRIMIDINES DERIVATIVES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM) ⤷  Sign Up
Australia 4474599 ⤷  Sign Up
Portugal 2682397 ⤷  Sign Up
Australia 665187 ⤷  Sign Up
China 103732594 Tenofovir alafenamide hemifumarate ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for ODEFSEY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 CR 2012 00019 Denmark ⤷  Sign Up PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
1419152 PA2012009,C1419152 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
1419152 C01419152/01 Switzerland ⤷  Sign Up PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: SWISSMEDIC 61548 26.02.2013
1663240 300781 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1663240 93383 Luxembourg ⤷  Sign Up PRODUCT 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,EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
1663240 2016/058 Ireland ⤷  Sign Up PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457)
0582455 08C0021 France ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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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