vemlidy Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Vemlidy, and what generic alternatives are available?
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for vemlidy?
- What are the global sales for vemlidy?
- What is Average Wholesale Price for vemlidy?
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.
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 | 9,296,769*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | 7,390,791*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | 8,754,065*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
>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 | 7,803,788 | ⤷ Subscribe |
>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: ⤷ Subscribe
Argentina
Patent: 7546
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 12296622
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Subscribe
Patent: 14271320
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2014003420
Patent: hemifumarato de tenofovir alafenamida
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 45553
Patent: HEMIFUMARATE DE TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 3732594
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Colombia
Patent: 80063
Patent: Hemifumarato de tenofovir alafenamida
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 140072
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0161696
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 18385
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 44810
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 14013206
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 7768
Patent: ТЕНОФОВИР АЛАФЕНАМИДА ГЕМИФУМАРАТ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
Patent: 1490208
Patent: ТЕНОФОВИР АЛАФЕНАМИДА ГЕМИФУМАРАТ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 44810
Patent: HÉMIFUMARATE DE TÉNOFOVIR ALAFÉNAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
Patent: 70088
Patent: TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
Patent: 31832
Patent: TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
Finland
Patent: 44810
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Hungary
Patent: 31253
Estimated Expiration: ⤷ Subscribe
India
Patent: 12DEN2014
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 0949
Patent: טנופוביר אלאפנאמיד המיפומאראט (Tenofovir alafenamide hemifumarate)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 51275
Estimated Expiration: ⤷ Subscribe
Patent: 56537
Estimated Expiration: ⤷ Subscribe
Patent: 80162
Estimated Expiration: ⤷ Subscribe
Patent: 14528924
Patent: テノホビルアラフェナミドヘミフマレート
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Lithuania
Patent: 44810
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 6627
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA. (TENOFOVIR ALAFENAMIDE HEMIFUMARATE.)
Estimated Expiration: ⤷ Subscribe
Patent: 14001549
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA. (TENOFOVIR ALAFENAMIDE HEMIFUMARATE.)
Estimated Expiration: ⤷ Subscribe
Moldova, Republic of
Patent: 08
Patent: Hemifumarat de tenofovir alafenamidă şi utilizările sale medicale (Tenofovir alafenamide hemifumarate and its medical uses)
Estimated Expiration: ⤷ Subscribe
Patent: 140011
Patent: Tenofovir alafenamid hemifumarat (Tenofovir alafenamide hemifumarate)
Estimated Expiration: ⤷ Subscribe
Montenegro
Patent: 612
Patent: TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
Morocco
Patent: 350
Patent: Hemifumarate de tenofovir alafenamide
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 0421
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 141328
Patent: TENOFOVIR ALAFENAMIDA HEMIFUMARATO
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 44810
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 44810
Estimated Expiration: ⤷ Subscribe
San Marino
Patent: 01600476
Patent: TENOFOVIR ALAFENAMMIDE EMIFUMARATO
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 353
Patent: TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 14011548
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 44810
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1400582
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1612642
Estimated Expiration: ⤷ Subscribe
Patent: 140054068
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 08871
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 16499
Estimated Expiration: ⤷ Subscribe
Patent: 1321396
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 5311
Patent: ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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 |
---|---|---|---|
Australia | 8294101 | ⤷ Subscribe | |
Canada | 2725819 | 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) | ⤷ Subscribe |
Japan | 6280162 | ⤷ Subscribe | |
Japan | 2014528924 | テノホビルアラフェナミドヘミフマレート | ⤷ Subscribe |
China | 1706855 | ⤷ Subscribe | |
Japan | 5651275 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vemlidy
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1419152 | 132012902054377 | Italy | ⤷ Subscribe | PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
2924034 | 2019/021 | Ireland | ⤷ Subscribe | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122 |
0582455 | 08C0021 | France | ⤷ Subscribe | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
1663240 | 2016/058 | Ireland | ⤷ Subscribe | 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) |
0915894 | C00915894/02 | Switzerland | ⤷ Subscribe | PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009 |
2924034 | CR 2019 00024 | Denmark | ⤷ Subscribe | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Vemlidy Market Analysis and Financial Projection Experimental
More… ↓