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Last Updated: January 24, 2020

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PIFELTRO Drug Profile

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Which patents cover Pifeltro, and what generic alternatives are available?

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-four patent family members in forty 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:64
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
Imperial College LondonPhase 1
University of LiverpoolPhase 1
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   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
>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 2019C/005 Belgium   Start Trial 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
2552902 LUC00113 Luxembourg   Start Trial PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20181127
2924034 CA 2019 00024 Denmark   Start Trial PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2924034 122019000042 Germany   Start Trial PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT TENOFOVIR ODER EINEM ESTER DAVON, EINSCHLIESSLICH EINEM DISOPROXILESTER, ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON, EINSCHLIESSLICH EINEM FUMARATSALZ; REGISTRATION NO/DATE: EU/1/18/1333 20181122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Boehringer Ingelheim
McKesson
AstraZeneca
Johnson and Johnson

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