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Last Updated: March 18, 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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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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 7546
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 12296622
Estimated Expiration: ⤷  Try a Trial

Patent: 14271320
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2014003420
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 45553
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 14000370
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3732594
Estimated Expiration: ⤷  Try a Trial

Patent: 0343135
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 80063
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 140072
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0161696
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18385
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 14013206
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 7768
Estimated Expiration: ⤷  Try a Trial

Patent: 1490208
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Patent: 70088
Estimated Expiration: ⤷  Try a Trial

Patent: 31832
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 99026
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31253
Estimated Expiration: ⤷  Try a Trial

India

Patent: 12DEN2014
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0949
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 51275
Estimated Expiration: ⤷  Try a Trial

Patent: 56537
Estimated Expiration: ⤷  Try a Trial

Patent: 80162
Estimated Expiration: ⤷  Try a Trial

Patent: 14528924
Estimated Expiration: ⤷  Try a Trial

Patent: 15038149
Estimated Expiration: ⤷  Try a Trial

Patent: 16169228
Estimated Expiration: ⤷  Try a Trial

Patent: 18065870
Estimated Expiration: ⤷  Try a Trial

Patent: 20040972
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6627
Estimated Expiration: ⤷  Try a Trial

Patent: 14001549
Estimated Expiration: ⤷  Try a Trial

Moldova, Republic of

Patent: 08
Estimated Expiration: ⤷  Try a Trial

Patent: 140011
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 612
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 350
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0421
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 141328
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600476
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 353
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 14011548
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1400582
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1612642
Estimated Expiration: ⤷  Try a Trial

Patent: 140054068
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 08871
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 16499
Estimated Expiration: ⤷  Try a Trial

Patent: 1321396
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 5311
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 262
Estimated Expiration: ⤷  Try a Trial

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
China 101068597 Fumarate of 4-((4-(4-(2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)benzonitrile ⤷  Try a Trial
Japan 3987335 ⤷  Try a Trial
Russian Federation 2125558 METHOD OF SYNTHESIS OF 2',3'-DIDEOXY-3'-THIACYTYDINE OR 2',3'- -DIDEOXY-3'-THIA-5-FLUOROCYTIDINE, NUCLEOSIDE ENRICHED WITH ENANTIOMER, METHOD OF SYNTHESIS OF 1,3-OXATHIOLANE, METHOD OF SYNTHESIS OF 2-ACYLOXY-5-ACYLOXY-1,3-OXATHIOLANE ENRICHED WITH ENANTIOMER, ENANTIOMERS, METHOD OF CLEAVAGE OF NUCLEOSIDE ENANTIOMERS ⤷  Try a Trial
Luxembourg 91073 ⤷  Try a Trial
Eurasian Patent Organization 200700534 ФУМАРАТ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА ⤷  Try a Trial
Norway 327639 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ODEFSEY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 300767 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
3808743 C 2022 032 Romania ⤷  Try a Trial PRODUCT NAME: COMBINATIE DE RILPIVIRINA SAU UN N-OXID, O SARE DE ADITIE ACCEPTABILA FARMACEUTIC, INCLUSIV SAREA CLORHIDRAT A RILPIVIRINEI SAU O FORMA IZOMERICA STEREOCHIMICA A RILPIVIRINEI SI EMTRICITABINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001-002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1419152 CR 2012 00019 Denmark ⤷  Try a Trial PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
1632232 SPC/GB17/007 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1419152 SPC/GB12/025 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE.; REGISTERED: UK EU/1/11/737/001 20111128
1301519 16C0013 France ⤷  Try a Trial 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
>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.