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 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ODEFSEY
*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
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
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 |
| >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 |
| >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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