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 |
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
Sponsor | Phase |
---|---|
Chelsea and Westminster NHS Foundation Trust | Phase 3 |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Phase 4 |
Merck Sharp & Dohme Corp. | Phase 4 |
Pharmacology for pifeltro
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 ⤷ Subscribe.
This potential generic entry date is based on patent 8,486,975.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 8,486,975 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Msd Merck Co | PIFELTRO | doravirine | TABLET;ORAL | 210806-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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: ⤷ Subscribe
Australia
Patent: 11235568
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2012024691
Patent: composto, e, composição farmacêutica
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 94377
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLEOSIDIQUES (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 2971308
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 30126
Patent: Inhibidores no nucleosídicos de la transcriptasa inversa
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 120503
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0150427
Estimated Expiration: ⤷ Subscribe
Patent: 0161680
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 16437
Estimated Expiration: ⤷ Subscribe
Patent: 18774
Estimated Expiration: ⤷ Subscribe
Patent: 19025
Estimated Expiration: ⤷ Subscribe
Patent: 19026
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 52902
Estimated Expiration: ⤷ Subscribe
Patent: 24034
Estimated Expiration: ⤷ Subscribe
Dominican Republic
Patent: 012000256
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 12012201
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 1290976
Patent: НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 52902
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLÉOSIDIQUES (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
Patent: 24034
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN INHIBITEUR NON NUCLÉOSIDIQUE DE TRANSCRIPTASE INVERSE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷ Subscribe
Finland
Patent: 0190020
Estimated Expiration: ⤷ Subscribe
Patent: 0190021
Estimated Expiration: ⤷ Subscribe
Georgia, Republic of
Patent: 0156368
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Honduras
Patent: 12002039
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 75471
Patent: 非核苷類逆轉錄酶抑制劑 (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Hungary
Patent: 25336
Estimated Expiration: ⤷ Subscribe
Patent: 31785
Estimated Expiration: ⤷ Subscribe
Patent: 900021
Estimated Expiration: ⤷ Subscribe
Patent: 900022
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 2030
Patent: מעכבי רוורס טרנסקיפטז לא נאוקלוזידי (Non-nucleoside reverse transcriptase inhibitors)
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Japan
Patent: 81718
Estimated Expiration: ⤷ Subscribe
Patent: 86790
Estimated Expiration: ⤷ Subscribe
Patent: 13209405
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
Estimated Expiration: ⤷ Subscribe
Patent: 13510800
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 552902
Estimated Expiration: ⤷ Subscribe
Patent: 924034
Estimated Expiration: ⤷ Subscribe
Patent: 2019506
Estimated Expiration: ⤷ Subscribe
Patent: 2019507
Estimated Expiration: ⤷ Subscribe
Patent: 24034
Estimated Expiration: ⤷ Subscribe
Luxembourg
Patent: 0114
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 3979
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 12011379
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA. (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS.)
Estimated Expiration: ⤷ Subscribe
Montenegro
Patent: 181
Patent: NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPT ASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
Patent: 570
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NE-NUKLEOZIDNI INHIBITOR REVERZNE TRANSKRIPTAZE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷ Subscribe
Morocco
Patent: 170
Patent: INHIBITEURS DE TRANSCRIPTASE INVERSE NON NUCLÉOSIDIQUES
Estimated Expiration: ⤷ Subscribe
Netherlands
Patent: 0980
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 2670
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Subscribe
Nicaragua
Patent: 1200146
Patent: INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 19018
Estimated Expiration: ⤷ Subscribe
Patent: 19019
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 130158
Patent: INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 52902
Estimated Expiration: ⤷ Subscribe
Patent: 24034
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 52902
Estimated Expiration: ⤷ Subscribe
Patent: 24034
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 017
Patent: NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
Patent: 505
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI NE-NUKLEOZIDNI INHIBITOR REVERZNE TRANSKRIPTAZE (PHARMACEUTICAL COMPOSITION COMPRISING A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 4347
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 52902
Estimated Expiration: ⤷ Subscribe
Patent: 24034
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1421861
Estimated Expiration: ⤷ Subscribe
Patent: 120128703
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 36295
Estimated Expiration: ⤷ Subscribe
Patent: 09636
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 58719
Estimated Expiration: ⤷ Subscribe
Patent: 1139409
Patent: Non-nucleoside reverse transcriptase inhibitors
Estimated Expiration: ⤷ Subscribe
Tunisia
Patent: 12000455
Patent: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 8495
Patent: НЕНУКЛЕОЗИДНІ ІНГІБІТОРИ ЗВОРОТНОЇ ТРАНСКРИПТАЗИ (REVERSE TRANSCRIPTASE NUCLEOSIDE INHIBITORS)
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Cyprus | 2019025 | ⤷ Subscribe | |
Poland | 2552902 | ⤷ Subscribe | |
Netherlands | 300980 | ⤷ Subscribe | |
New Zealand | 602670 | Non-nucleoside reverse transcriptase inhibitors | ⤷ Subscribe |
Cyprus | 1118774 | ⤷ Subscribe | |
Brazil | 112012024691 | composto, e, composição farmacêutica | ⤷ Subscribe |
Dominican Republic | P2012000256 | INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for pifeltro
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2924034 | 19C1025 | France | ⤷ Subscribe | PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE L0181126 AMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 2 |
2924034 | 122019000042 | Germany | ⤷ Subscribe | PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN UND TENOFOVIR-DISOPROXIL-FUMARAT; REGISTRATION NO/DATE: EU/1/18/1333 20181122 |
2552902 | 2019/020 | Ireland | ⤷ Subscribe | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1332/001, EU/1/18/1332/002, EU/1/18/1333/001, EU/1/18/1333/002, 20181122 |
2924034 | C201930027 | Spain | ⤷ Subscribe | PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA EN COMBINACION CON LAMIVUDINA Y TENOFOVIR DISOPROXILO FUMARATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122 |
2552902 | 19C1024 | France | ⤷ Subscribe | PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1333 20181126 |
2552902 | 1990025-7 | Sweden | ⤷ Subscribe | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126 |
2924034 | 132019000000062 | Italy | ⤷ Subscribe | PRODUCT NAME: DORAVIRINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON LAMIVUDINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON TENOFOVIR O UN SUO ESTERE, IN PARTICOLARE UN ESTERE DI DISOPROXIL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE UN SALE FUMARATO(DELSTRIGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1333/001-002, 20181127 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Pifeltro Market Analysis and Financial Projection Experimental
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