DESCOVY Drug Patent Profile
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When do Descovy patents expire, and when can generic versions of Descovy launch?
Descovy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and thirty-two patent family members in fifty countries.
The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
DrugPatentWatch® Generic Entry Outlook for Descovy
Descovy 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 seventeen 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
Summary for DESCOVY
| International Patents: | 132 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 17 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DESCOVY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DESCOVY |
| What excipients (inactive ingredients) are in DESCOVY? | DESCOVY excipients list |
| DailyMed Link: | DESCOVY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DESCOVY
*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 DESCOVY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ministry of Health, Thailand | Phase 3 |
| Assistance Publique - Hôpitaux de Paris, FRANCE | Phase 3 |
| Gilead Sciences | Phase 3 |
Pharmacology for DESCOVY
Anatomical Therapeutic Chemical (ATC) Classes for DESCOVY
Paragraph IV (Patent) Challenges for DESCOVY
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| DESCOVY | Tablets | emtricitabine; tenofovir alafenamide fumarate | 120 mg/15 mg | 208215 | 1 | 2022-10-31 |
| DESCOVY | Tablets | emtricitabine; tenofovir alafenamide fumarate | 200 mg/25 mg | 208215 | 6 | 2019-11-05 |
US Patents and Regulatory Information for DESCOVY
DESCOVY is protected by three US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DESCOVY is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ 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.
Patents protecting DESCOVY
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 DESCOVY
TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 14 KG TO LESS THAN 25 KG
Exclusivity Expiration: ⤷ Sign Up
IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG
Exclusivity Expiration: ⤷ Sign Up
IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG
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 | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-002 | Jan 7, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-002 | Jan 7, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-002 | Jan 7, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-002 | Jan 7, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | 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 DESCOVY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DESCOVY
When does loss-of-exclusivity occur for DESCOVY?
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 DESCOVY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | 230960 | Prodrugs of phosphonate nucleotide analogues and compositions thereof | ⤷ Sign Up |
| Moldova, Republic of | 4508 | Hemifumarat de tenofovir alafenamidă şi utilizările sale medicale (Tenofovir alafenamide hemifumarate and its medical uses) | ⤷ Sign Up |
| Croatia | P20160074 | ⤷ Sign Up | |
| Netherlands | 300148 | ⤷ Sign Up | |
| Czech Republic | 304734 | Způsob přípravy 9-[2-(fosfonomethoxy)propyl]adeninu a 9-[2-(fosfonomethoxy)ethyl]adeninu (Process for preparing 9-[2-(phosphonomethoxy)propyl]adenine and 9-[2-(phosphonomethoxy)ethyl]adenine) | ⤷ Sign Up |
| Japan | 2010013466 | USE OF 1-(2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)-CYTOSINE FOR TREATMENT OF HEPATITIS B | ⤷ Sign Up |
| Japan | 2010174033 | PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOGUE AND METHOD FOR SCREENING AND PRODUCING THE SAME | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DESCOVY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1301519 | 122016000024 | Germany | ⤷ Sign Up | PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| 0915894 | 05C0032 | France | ⤷ Sign Up | PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221 |
| 0513200 | SPC/GB04/016 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024 |
| 1301519 | CA 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 |
| 0582455 | 08C0021 | France | ⤷ Sign Up | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
| 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 |
| 1301519 | 132016000035069 | Italy | ⤷ Sign Up | PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123 |
| >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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