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Last Updated: August 8, 2020

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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-six patent family members in forty-one countries.

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

US ANDA Litigation and 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:66
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 2
Drug Prices: Drug price information for PIFELTRO
DailyMed Link:PIFELTRO at DailyMed
Drug patent expirations by year for PIFELTRO
Drug Prices for PIFELTRO

See drug prices for PIFELTRO

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
Chelsea and Westminster NHS Foundation TrustPhase 1
Imperial College LondonPhase 1
University of LiverpoolPhase 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   Start Trial   Start Trial Y Y   Start Trial
Msd Merck Co PIFELTRO doravirine TABLET;ORAL 210806-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Msd Merck Co PIFELTRO doravirine TABLET;ORAL 210806-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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
2552902 122019000038 Germany   Start Trial
2924034 19C1025 France   Start Trial PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE LAMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 20181126
2924034 CA 2019 00024 Denmark   Start Trial PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2552902 2019C/004 Belgium   Start Trial PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2552902 300980 Netherlands   Start Trial PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca
Moodys
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