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Last Updated: October 23, 2021

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Details for New Drug Application (NDA): 210807


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NDA 210807 describes DELSTRIGO, which is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DELSTRIGO profile page.

The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. One supplier is listed for this compound. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.
Summary for 210807
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 210807
Generic Entry Date for 210807*:
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.

Suppliers and Packaging for NDA: 210807
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807 NDA Merck Sharp & Dohme Corp. 0006-5007 0006-5007-01 30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG;300MG;300MG
Approval Date:Aug 30, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 19, 2022
Regulatory Exclusivity Use:EXPANDED INDICATION FOR PTS WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML) ON A STABLE ARV REGIMEN WITH NO HX OF TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W RESISTANCE TO DORAVIRINE, LAMIVUDINE OR TENOFOVIR DISOPROXIL FUMARATE
Regulatory Exclusivity Expiration:Aug 30, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try it FreePatent Expiration:Nov 29, 2036Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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