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Last Updated: November 7, 2024

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ODEFSEY Drug Patent Profile


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Which patents cover Odefsey, and what generic alternatives are available?

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
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*:
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.

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

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

Expired US Patents for ODEFSEY

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
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 7546
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 12296622
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷  Sign Up

Patent: 14271320
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014003420
Patent: hemifumarato de tenofovir alafenamida
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 45553
Patent: HEMIFUMARATE DE TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14000370
Patent: Hemifumarato de tenofovir alafenamida; metodo de preparación; composicion farmaceutica que lo comprende; metodo para preparar la composicion farmaceutica; y uso en el tratamiento de una infeccion por hiv.
Estimated Expiration: ⤷  Sign Up

China

Patent: 3732594
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷  Sign Up

Patent: 0343135
Patent: 替诺福韦艾拉酚胺(TENOFOVIR ALAFENAMIDE)半反丁烯二酸盐 (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 80063
Patent: Hemifumarato de tenofovir alafenamida
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 140072
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
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
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 7768
Patent: ТЕНОФОВИР АЛАФЕНАМИДА ГЕМИФУМАРАТ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 1490208
Patent: ТЕНОФОВИР АЛАФЕНАМИДА ГЕМИФУМАРАТ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 44810
Patent: HÉMIFUMARATE DE TÉNOFOVIR ALAFÉNAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 70088
Patent: TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 31832
Patent: TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 99026
Patent: 替諾福韋艾拉酚胺 半反丁烯二酸鹽 (TENOFOVIR ALAFENAMIDE HEMIFUMARATE (TENOFOVIRALAFENAMIDE))
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 31253
Estimated Expiration: ⤷  Sign Up

India

Patent: 12DEN2014
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0949
Patent: טנופוביר אלאפנאמיד המיפומאראט (Tenofovir alafenamide hemifumarate)
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
Patent: テノホビルアラフェナミドヘミフマレート
Estimated Expiration: ⤷  Sign Up

Patent: 15038149
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 16169228
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 18065870
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 20040972
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6627
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA. (TENOFOVIR ALAFENAMIDE HEMIFUMARATE.)
Estimated Expiration: ⤷  Sign Up

Patent: 14001549
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA. (TENOFOVIR ALAFENAMIDE HEMIFUMARATE.)
Estimated Expiration: ⤷  Sign Up

Moldova, Republic of

Patent: 08
Patent: Hemifumarat de tenofovir alafenamidă şi utilizările sale medicale (Tenofovir alafenamide hemifumarate and its medical uses)
Estimated Expiration: ⤷  Sign Up

Patent: 140011
Patent: Tenofovir alafenamid hemifumarat (Tenofovir alafenamide hemifumarate)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 612
Patent: TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 350
Patent: Hemifumarate de tenofovir alafenamide
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0421
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 141328
Patent: TENOFOVIR ALAFENAMIDA HEMIFUMARATO
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 44810
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 44810
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01600476
Patent: TENOFOVIR ALAFENAMMIDE EMIFUMARATO
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 353
Patent: TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 14011548
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 44810
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1400582
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1612642
Estimated Expiration: ⤷  Sign Up

Patent: 140054068
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 08871
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 16499
Estimated Expiration: ⤷  Sign Up

Patent: 1321396
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 5311
Patent: ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 262
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA, SUS COMPOSICIONES, MÉTODO DE PREPARACIÓN, MÉTODOS PARA TRATAR INFECCIONES VIRALES Y SU USO PARA PREPARAR MEDI CAMENTOS
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
Argentina 046812 COMBINACIONES DE UN INHIBIDOR DE LA TRANSCRIPTASA INVERSA NO NUCLEOSIDO (NNRTI) CON CONTENIDO DE PIRIMIDINA CON INHIBIDORES DE LA TRANSCRIPTASA INVERSA ⤷  Sign Up
Czech Republic 9301835 ⤷  Sign Up
Hong Kong 1210029 -氰基乙烯基 -二甲基苯基 氨基 -嘧啶基 氨基 苄腈的鹽酸鹽 (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6- DIMETHYLPHENYL]AMINO]-2- PYRIMIDINYL]AMINO]BENZONITRILE 4-[[4-[[4-(2-)-26-]]-2-]]) ⤷  Sign Up
Czech Republic 2003413 ⤷  Sign Up
China 101816658 HIV inhibiting pyrimidines derivatives ⤷  Sign Up
Taiwan 200628155 HIV replication inhibiting pyrimidines ⤷  Sign Up
Norway 20083770 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ODEFSEY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1301519 16C0013 France ⤷  Sign Up PRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1663240 93382 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 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
0915894 05C0032 France ⤷  Sign Up PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
1301519 2016/014 Ireland ⤷  Sign Up PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061/001-EU/1/15/1061/002 20151119
1419152 2012C/020 Belgium ⤷  Sign Up PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130
1663240 C20150040 00167 Estonia ⤷  Sign Up PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
1663240 132016000024787 Italy ⤷  Sign Up PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, TENOFOVIR, IN PARTICOLARE TENOFOVIR DISOPROXIL FUMARATO E EMITRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
>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.