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® Litigation and Generic Entry Outlook for Vemlidy
A generic version of VEMLIDY was approved as tenofovir alafenamide fumarate by APOTEX on March 21st, 2024.
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: ⤷ 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
Estimated Expiration: ⤷ Sign Up
Argentina
Patent: 7546
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 12296622
Estimated Expiration: ⤷ Sign Up
Patent: 14271320
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014003420
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 45553
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14000370
Estimated Expiration: ⤷ Sign Up
China
Patent: 3732594
Estimated Expiration: ⤷ Sign Up
Patent: 0343135
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 80063
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 140072
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
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7768
Estimated Expiration: ⤷ Sign Up
Patent: 1490208
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 44810
Estimated Expiration: ⤷ Sign Up
Patent: 70088
Estimated Expiration: ⤷ Sign Up
Patent: 31832
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 44810
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 99026
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 31253
Estimated Expiration: ⤷ Sign Up
India
Patent: 12DEN2014
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0949
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
Estimated Expiration: ⤷ Sign Up
Patent: 15038149
Estimated Expiration: ⤷ Sign Up
Patent: 16169228
Estimated Expiration: ⤷ Sign Up
Patent: 18065870
Estimated Expiration: ⤷ Sign Up
Patent: 20040972
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 44810
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 6627
Estimated Expiration: ⤷ Sign Up
Patent: 14001549
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 08
Estimated Expiration: ⤷ Sign Up
Patent: 140011
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 612
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 350
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0421
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 141328
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 44810
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 44810
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01600476
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 353
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 14011548
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 44810
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1400582
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1612642
Estimated Expiration: ⤷ Sign Up
Patent: 140054068
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 08871
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 16499
Estimated Expiration: ⤷ Sign Up
Patent: 1321396
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 5311
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 262
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 |
|---|---|---|---|
| South Africa | 201400582 | TENOFOVIR ALAFENAMIDE HEMIFUMARATE | ⤷ Sign Up |
| Japan | 5111551 | ⤷ Sign Up | |
| Japan | 2009062383 | PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOGUE AND METHOD FOR SELECTING AND PREPARING THE SAME | ⤷ Sign Up |
| Croatia | P20161696 | ⤷ Sign Up | |
| Japan | 2020040972 | テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) | ⤷ Sign Up |
| Australia | 2014271320 | TENOFOVIR ALAFENAMIDE HEMIFUMARATE | ⤷ Sign Up |
| Japan | 2014528924 | テノホビルアラフェナミドヘミフマレート | ⤷ 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 | CR 2016 00012 | Denmark | ⤷ Sign Up | PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
| 1301519 | PA2016009,C1301519 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119 |
| 3281939 | 122023000055 | Germany | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR UND TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| 2487166 | 300860 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123 |
| 1663240 | 223 5021-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
| 1419152 | 132012902054377 | Italy | ⤷ Sign Up | PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
| 0915894 | SPC/GB05/041 | United Kingdom | ⤷ Sign Up | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020. |
| >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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