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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210806


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NDA 210806 describes PIFELTRO, which is a drug marketed by Msd Merck Co and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the PIFELTRO profile page.

The generic ingredient in PIFELTRO is doravirine. Two suppliers are listed for this compound. Additional details are available on the doravirine profile page.
Summary for 210806
Tradename:PIFELTRO
Applicant:Msd Merck Co
Ingredient:doravirine
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210806
Generic Entry Date for 210806*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 210806
Suppliers and Packaging for NDA: 210806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIFELTRO doravirine TABLET;ORAL 210806 NDA Merck Sharp & Dohme LLC 0006-3069 0006-3069-01 30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)
PIFELTRO doravirine TABLET;ORAL 210806 NDA A-S Medication Solutions 50090-6237 50090-6237-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-6237-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 30, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 27, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try a TrialPatent Expiration:Oct 7, 2031Product Flag?YSubstance Flag?YDelist Request?
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
Patent:⤷  Try a TrialPatent Expiration:Oct 7, 2031Product Flag?YSubstance Flag?YDelist Request?
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

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