VEMLIDY Drug Patent Profile
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When do Vemlidy patents expire, and when can generic versions of Vemlidy launch?
Vemlidy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and thirty-two patent family members in fifty countries.
The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.
DrugPatentWatch® Generic Entry Outlook for Vemlidy
Vemlidy was eligible for patent challenges on November 5, 2019.
There have been four 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.
There is one tentative approval for the generic drug (tenofovir alafenamide fumarate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Questions you can ask:
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Summary for VEMLIDY
| International Patents: | 132 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 83 |
| Clinical Trials: | 18 |
| Patent Applications: | 512 |
| Drug Prices: | Drug price information for VEMLIDY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VEMLIDY |
| What excipients (inactive ingredients) are in VEMLIDY? | VEMLIDY excipients list |
| DailyMed Link: | VEMLIDY at DailyMed |
Paragraph IV (Patent) Challenges for VEMLIDY
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VEMLIDY | Tablets | tenofovir alafenamide fumarate | 25 mg | 208464 | 6 | 2019-11-05 |
US Patents and Regulatory Information for VEMLIDY
VEMLIDY is protected by three US patents and one FDA Regulatory Exclusivity.
Patents protecting VEMLIDY
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
FDA Regulatory Exclusivity protecting VEMLIDY
NEW PATIENT POPULATION
Exclusivity 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 | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | 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 VEMLIDY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VEMLIDY
When does loss-of-exclusivity occur for VEMLIDY?
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 VEMLIDY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Ukraine | 75889 | ПРОЛЕКАРСТВА АНАЛОГОВ ФОСФОНАТНУКЛЕОТИДА, СПОСОБ ИХ СЕЛЕКЦИИ И ПОЛУЧЕНИЯ;ПРОЛІКИ АНАЛОГІВ ФОСФОНАТНУКЛЕОТИДУ, СПОСІБ ЇХ СЕЛЕКЦІЇ ТА ОДЕРЖАННЯ (PHOSPHONATNUCLEOTIDE ANALOGS PRODRUGS, A METHOD FOR SELECTION AND PREPARATION THEREOF) | ⤷ Sign Up |
| San Marino | T201600476 | TENOFOVIR ALAFENAMMIDE EMIFUMARATO | ⤷ Sign Up |
| Poland | 213214 | ⤷ Sign Up | |
| Hungary | E031253 | ⤷ Sign Up | |
| Canada | 2416757 | PROMEDICAMENTS A BASE D'ANALOGUES NUCLEOTIDIQUES DE PHOSPHONATE ET LEURS METHODES DE SELECTION ET D'ELABORATION (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VEMLIDY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1301519 | SPC/GB16/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123 |
| 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 |
| 2487166 | 2017003 | Norway | ⤷ Sign Up | PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209 |
| 1419152 | 22/2012 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBAREN ADDITIONSSALZEN VON RILPIVIRIN, EINSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 0915894 | 08C0020 | 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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