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.
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
| Tradename: | DELSTRIGO |
| Applicant: | Msd Merck Co |
| Ingredient: | doravirine; lamivudine; tenofovir disoproxil fumarate |
| Patents: | 3 |
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.
Pharmacology for NDA: 210807
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 LLC | 0006-5007 | 0006-5007-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;300MG;300MG | ||||
| Approval Date: | Aug 30, 2018 | TE: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Jan 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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