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. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the doravirine profile page.
The generic ingredient in PIFELTRO is doravirine. There is one drug master file entry for this compound. 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
| Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
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 | 50090-6268 | 50090-6268-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6268-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 30, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 30, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist 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: | ⤷ Start Trial | Patent Expiration: | Aug 30, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist 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 | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 30, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | FOR USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS TO TREAT HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IF VIROLOGICALLY SUPPRESSED | ||||||||
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