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
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: | 240 |
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
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Msd Merck Co | PIFELTRO | doravirine | TABLET;ORAL | 210806-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 11235568
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012024691
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 94377
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 12002744
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2971308
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 30126
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 120503
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0150427
Estimated Expiration: ⤷ Try a Trial
Patent: 0161680
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16437
Estimated Expiration: ⤷ Try a Trial
Patent: 18774
Estimated Expiration: ⤷ Try a Trial
Patent: 19025
Estimated Expiration: ⤷ Try a Trial
Patent: 19026
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 52902
Estimated Expiration: ⤷ Try a Trial
Patent: 24034
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 012000256
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 12012201
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 4804
Estimated Expiration: ⤷ Try a Trial
Patent: 1290976
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 52902
Estimated Expiration: ⤷ Try a Trial
Patent: 24034
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 0190020
Estimated Expiration: ⤷ Try a Trial
Patent: 0190021
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0156368
Estimated Expiration: ⤷ Try a Trial
Honduras
Patent: 12002039
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 75471
Estimated Expiration: ⤷ Try a Trial
Patent: 09121
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 25336
Estimated Expiration: ⤷ Try a Trial
Patent: 31785
Estimated Expiration: ⤷ Try a Trial
Patent: 900021
Estimated Expiration: ⤷ Try a Trial
Patent: 900022
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 2030
Estimated Expiration: ⤷ Try a Trial
Patent: 3334
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 81718
Estimated Expiration: ⤷ Try a Trial
Patent: 86790
Estimated Expiration: ⤷ Try a Trial
Patent: 13209405
Estimated Expiration: ⤷ Try a Trial
Patent: 13510800
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 552902
Estimated Expiration: ⤷ Try a Trial
Patent: 924034
Estimated Expiration: ⤷ Try a Trial
Patent: 2019506
Estimated Expiration: ⤷ Try a Trial
Patent: 2019507
Estimated Expiration: ⤷ Try a Trial
Patent: 24034
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 0114
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3979
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 12011379
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 181
Estimated Expiration: ⤷ Try a Trial
Patent: 570
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 170
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 0980
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2670
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 1200146
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 19018
Estimated Expiration: ⤷ Try a Trial
Patent: 19019
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 130158
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 52902
Estimated Expiration: ⤷ Try a Trial
Patent: 24034
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 52902
Estimated Expiration: ⤷ Try a Trial
Patent: 24034
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 017
Estimated Expiration: ⤷ Try a Trial
Patent: 505
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 4347
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 52902
Estimated Expiration: ⤷ Try a Trial
Patent: 24034
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1421861
Estimated Expiration: ⤷ Try a Trial
Patent: 120128703
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 36295
Estimated Expiration: ⤷ Try a Trial
Patent: 09636
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 58719
Estimated Expiration: ⤷ Try a Trial
Patent: 1139409
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 12000455
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 8495
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Israel | 233334 | 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) | ⤷ Try a Trial |
Eurasian Patent Organization | 024804 | НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ, КОМПОЗИЦИИ, ИХ СОДЕРЖАЩИЕ, И ИХ ПРИМЕНЕНИЕ (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS, COMPOSITIONS COMPRISING THEM, AND USE THEREOF) | ⤷ Try a Trial |
Cyprus | 1116437 | ⤷ Try a Trial | |
Lithuania | PA2019506 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PIFELTRO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2924034 | 1990024-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126 |
2924034 | 132019000000062 | Italy | ⤷ Try a Trial | 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 |
2552902 | 19C1024 | France | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1333 20181126 |
2552902 | CA 2019 00025 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |