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
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: | 337 |
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: ⤷ 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
FDA Regulatory Exclusivity protecting VEMLIDY
NEW PATIENT POPULATION
Exclusivity 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 | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
>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
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 VEMLIDY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 336627 | HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA. (TENOFOVIR ALAFENAMIDE HEMIFUMARATE.) | ⤷ Try a Trial |
European Patent Office | 3235823 | ⤷ Try a Trial | |
Japan | 2011140506 | PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOG AND METHOD FOR SELECTING AND PRODUCING THE SAME | ⤷ Try a Trial |
Argentina | 087546 | HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA | ⤷ Try a Trial |
Hong Kong | 1054238 | ⤷ Try a Trial | |
Slovenia | 1301519 | ⤷ Try a Trial | |
Peru | 20141328 | TENOFOVIR ALAFENAMIDA HEMIFUMARATO | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VEMLIDY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 300850 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
1632232 | 122016000110 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
1663240 | PA2016044 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
2924034 | 2019C/005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126 |
1419152 | CR 2012 00021 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128 |
1301519 | SPC/GB16/015 | United Kingdom | ⤷ Try a Trial | 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 | 2015/054 | Ireland | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |