Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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 one supplier. There is one patent protecting this drug. Additional details are available on the PIFELTRO profile page.

The generic ingredient in PIFELTRO is doravirine. One supplier is 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
Generic Entry Opportunity 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 Corp. 0006-3069 0006-3069-01 30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 30, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 30, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start 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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Serving leading biopharmaceutical companies globally:

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Moodys

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