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Last Updated: July 15, 2024

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PIFELTRO Drug Patent Profile


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When do Pifeltro patents expire, and when can generic versions of Pifeltro launch?

Pifeltro is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

This drug has seventy-three patent family members in forty-four countries.

The generic ingredient in PIFELTRO is doravirine. Two suppliers are listed for this compound. Additional details are available on the doravirine profile page.

DrugPatentWatch® Generic Entry Outlook for Pifeltro

Pifeltro was eligible for patent challenges on August 30, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 7, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PIFELTRO
International Patents:73
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 57
Clinical Trials: 4
Patent Applications: 175
Drug Prices: Drug price information for PIFELTRO
What excipients (inactive ingredients) are in PIFELTRO?PIFELTRO excipients list
DailyMed Link:PIFELTRO at DailyMed
Drug patent expirations by year for PIFELTRO
Drug Prices for PIFELTRO

See drug prices for PIFELTRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PIFELTRO
Generic Entry Date for PIFELTRO*:
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 PIFELTRO

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

SponsorPhase
Chelsea and Westminster NHS Foundation TrustPhase 3
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaPhase 4
Merck Sharp & Dohme Corp.Phase 4

See all PIFELTRO clinical trials

US Patents and Regulatory Information for PIFELTRO

PIFELTRO is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PIFELTRO 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 PIFELTRO

Non-nucleoside reverse transcriptase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO DORAVIRINE

Non-nucleoside reverse transcriptase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY

Non-nucleoside reverse transcriptase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS TO TREAT HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IF VIROLOGICALLY SUPPRESSED

FDA Regulatory Exclusivity protecting PIFELTRO

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
Msd Merck Co PIFELTRO doravirine TABLET;ORAL 210806-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Msd Merck Co PIFELTRO doravirine TABLET;ORAL 210806-001 Aug 30, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for PIFELTRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Pifeltro doravirine EMEA/H/C/004747
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.
Authorised no no no 2018-11-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PIFELTRO

When does loss-of-exclusivity occur for PIFELTRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0859
Patent: DERIVADOS 1,2,4 TRIAZOLO-PIRIDINICOS INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA, UTILES PARA TRATAR INFECCIONES POR VIH Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN.
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11235568
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012024691
Patent: composto, e, composição farmacêutica
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 94377
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLEOSIDIQUES (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12002744
Patent: Compuesto inhibidor no nucleosídico de la transcriptasa inversa derivado de 3-(hidrocarbiloxi aromático y alifático opcionalmente sustituido)-1-[(5-oxo-4,5-dihidro-1h-1,2,4-triazol-3-il)metil])-piridin-2(ih)-ona; composición farmacéutica que lo comprende útil en la profilaxis y tratamiento de la infección por vih y sida.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2971308
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 30126
Patent: Inhibidores no nucleosídicos de la transcriptasa inversa
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120503
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150427
Estimated Expiration: ⤷  Sign Up

Patent: 0161680
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16437
Estimated Expiration: ⤷  Sign Up

Patent: 18774
Estimated Expiration: ⤷  Sign Up

Patent: 19025
Estimated Expiration: ⤷  Sign Up

Patent: 19026
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 012000256
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 12012201
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 4804
Patent: НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ, КОМПОЗИЦИИ, ИХ СОДЕРЖАЩИЕ, И ИХ ПРИМЕНЕНИЕ (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS, COMPOSITIONS COMPRISING THEM, AND USE THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 1290976
Patent: НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 52902
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLÉOSIDIQUES (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN INHIBITEUR NON NUCLÉOSIDIQUE DE TRANSCRIPTASE INVERSE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 0190020
Estimated Expiration: ⤷  Sign Up

Patent: 0190021
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0156368
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 12002039
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 75471
Patent: 非核苷類逆轉錄酶抑制劑 (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 09121
Patent: 包含非核苷逆轉錄酶抑制劑的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 25336
Estimated Expiration: ⤷  Sign Up

Patent: 31785
Estimated Expiration: ⤷  Sign Up

Patent: 900021
Estimated Expiration: ⤷  Sign Up

Patent: 900022
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2030
Patent: מעכבי רוורס טרנסקיפטז לא נאוקלוזידי (Non-nucleoside reverse transcriptase inhibitors)
Estimated Expiration: ⤷  Sign Up

Patent: 3334
Patent: תרכובות 3-(הידרוקרבילאוקסי ארומטי ואליפטי המותמר אופציונאלית)-1-[(5-אוקסו-5,4-דיהידרו-1h-4,2,1-טריאזול-3-איל)מתיל]-פירידין-2-(1h)- און, הרכב רוקחי המכיל אותן ושימוש בהן (3-(optionally substituted aromatic and aliphatic hydrocarbyloxy)-1-[(5-oxo-4,5-dihydro-1h-1,2,4-triazol-3-yl)methyl]-pyridin-2(1h)-one compounds, pharmaceutical composition comprising same, and use thereof)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 81718
Estimated Expiration: ⤷  Sign Up

Patent: 86790
Estimated Expiration: ⤷  Sign Up

Patent: 13209405
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
Estimated Expiration: ⤷  Sign Up

Patent: 13510800
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 552902
Estimated Expiration: ⤷  Sign Up

Patent: 924034
Estimated Expiration: ⤷  Sign Up

Patent: 2019506
Estimated Expiration: ⤷  Sign Up

Patent: 2019507
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0114
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3979
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12011379
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA. (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 181
Patent: NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPT ASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 570
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NE-NUKLEOZIDNI INHIBITOR REVERZNE TRANSKRIPTAZE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 170
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLÉOSIDIQUES
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0980
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2670
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1200146
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 19018
Estimated Expiration: ⤷  Sign Up

Patent: 19019
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 130158
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 017
Patent: NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 505
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NE-NUKLEOZIDNI INHIBITOR REVERZNE TRANSKRIPTAZE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 4347
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 52902
Estimated Expiration: ⤷  Sign Up

Patent: 24034
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1421861
Estimated Expiration: ⤷  Sign Up

Patent: 120128703
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 36295
Estimated Expiration: ⤷  Sign Up

Patent: 09636
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 58719
Estimated Expiration: ⤷  Sign Up

Patent: 1139409
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 12000455
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 8495
Patent: НЕНУКЛЕОЗИДНІ ІНГІБІТОРИ ЗВОРОТНОЇ ТРАНСКРИПТАЗИ (REVERSE TRANSCRIPTASE NUCLEOSIDE INHIBITORS)
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 PIFELTRO around the world.

Country Patent Number Title Estimated Expiration
Ecuador SP12012201 INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA ⤷  Sign Up
Netherlands 300980 ⤷  Sign Up
Malaysia 163979 NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS ⤷  Sign Up
Croatia P20150427 ⤷  Sign Up
Colombia 6630126 Inhibidores no nucleosídicos de la transcriptasa inversa ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PIFELTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2552902 CA 2019 00025 Denmark ⤷  Sign Up PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126
2924034 2019/021 Ireland ⤷  Sign Up 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
2924034 2019C/005 Belgium ⤷  Sign Up 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
2924034 PA2019507 Lithuania ⤷  Sign Up PRODUCT NAME: DORAVIRINAS ARBA JO DRUSKA, LAMIVUDINAS ARBA JO DRUSKA, TENOFOVIRAS ARBA JO ESTERIS, YPAC DIZOPROKSILO ESTERIS ARBA JO DRUSKA, YPAC FUMARATO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2924034 CA 2019 00024 Denmark ⤷  Sign Up PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
>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.