Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Harvard Business School
AstraZeneca
Colorcon
Dow

Last Updated: May 26, 2022

VEMLIDY Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-two patent family members in forty-nine 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.

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 three 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

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for VEMLIDY
Drug Prices for VEMLIDY

See drug prices for VEMLIDY

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VEMLIDY
Generic Entry Date for VEMLIDY*:
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.

Recent Clinical Trials for VEMLIDY

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shanghai Tong Ren HospitalPhase 2
Shanghai East HospitalPhase 2
Shanghai HEP Pharmaceutical Co., Ltd.Phase 2

See all VEMLIDY clinical trials

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 four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VEMLIDY is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 VEMLIDY

Prodrugs of phosphonate nucleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of phosphonate nucoleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting VEMLIDY

INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4018 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALAFENAMIDE
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4035 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALFAENAMIDE
Exclusivity Expiration: See Plans and Pricing

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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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: See Plans and Pricing

Argentina

Patent: 7546
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12296622
Estimated Expiration: See Plans and Pricing

Patent: 14271320
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014003420
Estimated Expiration: See Plans and Pricing

Canada

Patent: 45553
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14000370
Estimated Expiration: See Plans and Pricing

China

Patent: 3732594
Estimated Expiration: See Plans and Pricing

Patent: 0343135
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 80063
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140072
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161696
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18385
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 44810
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14013206
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7768
Estimated Expiration: See Plans and Pricing

Patent: 1490208
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 44810
Estimated Expiration: See Plans and Pricing

Patent: 70088
Estimated Expiration: See Plans and Pricing

Patent: 31832
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 99026
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31253
Estimated Expiration: See Plans and Pricing

India

Patent: 12DEN2014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0949
Estimated Expiration: See Plans and Pricing

Patent: 0649
Estimated Expiration: See Plans and Pricing

Japan

Patent: 51275
Estimated Expiration: See Plans and Pricing

Patent: 56537
Estimated Expiration: See Plans and Pricing

Patent: 80162
Estimated Expiration: See Plans and Pricing

Patent: 14528924
Estimated Expiration: See Plans and Pricing

Patent: 15038149
Estimated Expiration: See Plans and Pricing

Patent: 16169228
Estimated Expiration: See Plans and Pricing

Patent: 18065870
Estimated Expiration: See Plans and Pricing

Patent: 20040972
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 44810
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6627
Estimated Expiration: See Plans and Pricing

Patent: 14001549
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 08
Estimated Expiration: See Plans and Pricing

Patent: 140011
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 612
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 350
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0421
Estimated Expiration: See Plans and Pricing

Peru

Patent: 141328
Estimated Expiration: See Plans and Pricing

Poland

Patent: 44810
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 44810
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600476
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 353
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 14011548
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 44810
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1400582
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1612642
Estimated Expiration: See Plans and Pricing

Patent: 140054068
Estimated Expiration: See Plans and Pricing

Spain

Patent: 08871
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 16499
Estimated Expiration: See Plans and Pricing

Patent: 1321396
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5311
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 262
Estimated Expiration: See Plans and Pricing

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
Slovenia 2744810 See Plans and Pricing
Eurasian Patent Organization 004926 ПРОЛЕКАРСТВЕННЫЕ СОЕДИНЕНИЯ ФОСФОНАТНЫХ АНАЛОГОВ НУКЛЕОТИДОВ (ВАРИАНТЫ), СПОСОБ ИХ ПОЛУЧЕНИЯ, СПОСОБ СКРИНИНГА ДЛЯ ИХ ИДЕНТИФИКАЦИИ И СОДЕРЖАЩАЯ ИХ КОМПОЗИЦИЯ, СПОСОБ АНТИВИРУСНОЙ ТЕРАПИИ ИЛИ ПРОФИЛАКТИКИ (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES, METHOD FOR METHOD FOR SCREENING TO IDENTIFY THEREOF, METHOD FOR ANTI-VIRAL THERAPY OR PROPHYLAXIS) See Plans and Pricing
China 1443189 See Plans and Pricing
Denmark 2682397 See Plans and Pricing
Australia 2005225039 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VEMLIDY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1301519 16C0013 France See Plans and Pricing 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 92855 Luxembourg See Plans and Pricing 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 , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
1301519 CA 2016 00012 Denmark See Plans and Pricing PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
1419152 162 5010-2012 Slovakia See Plans and Pricing PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
1419152 12C0036 France See Plans and Pricing PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
McKesson
Baxter
Colorcon
McKinsey

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.