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The generic ingredient in PIFELTRO is doravirine. One supplier is listed for this compound. Additional details are available on the doravirine profile page.
Generic Entry Opportunity Date for 210806
*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 |
Profile for product number 001
|Approval Date:||Aug 30, 2018||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Aug 30, 2023|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||Start Trial||Patent Expiration:||Oct 7, 2031||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|
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