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Last Updated: May 8, 2021

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PIFELTRO Drug 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 sixty-eight patent family members in forty-two countries.

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

DrugPatentWatch® Generic Entry Outlook for Pifeltro

Pifeltro will be eligible for patent challenges on August 30, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:68
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 3
Patent Applications: 125
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 Generic Entry Opportunity 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
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
Chelsea and Westminster NHS Foundation TrustPhase 1

See all PIFELTRO clinical trials

US Patents and Regulatory Information for PIFELTRO

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   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Msd Merck Co PIFELTRO doravirine TABLET;ORAL 210806-001 Aug 30, 2018 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Msd Merck Co PIFELTRO doravirine TABLET;ORAL 210806-001 Aug 30, 2018 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for PIFELTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 CR 2019 00024 Denmark   Get Started for $10 PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2552902 2019019 Norway   Get Started for $10 PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/18/1332/001-2 20181213
2552902 2019C/004 Belgium   Get Started for $10 PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2552902 132019000000060 Italy   Get Started for $10 PRODUCT NAME: DORAVIRINA O UN SUO SALE FARMAEUTICAMENTE ACCETTABILE(PIFELTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1332, 20181127
2924034 LUC00114 Luxembourg   Get Started for $10 PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126
2924034 300981 Netherlands   Get Started for $10 PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, 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; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
2552902 2019/020 Ireland   Get Started for $10 PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT AUTHORISATION NO/DATE: EU/1/18/1332/001 EU/1/18/1332/002 20181122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

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