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The generic ingredient in TYBOST is cobicistat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat profile page.
Generic Entry Opportunity Date for 203094
*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: 203094
Profile for product number 001
|Approval Date:||Sep 24, 2014||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Aug 22, 2026|
|Regulatory Exclusivity Use:||INDICATED TO INCREASE SYSTEMIC EXPOSURE OF ATAZANAVIR IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS IN THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35 KG|
|Regulatory Exclusivity Expiration:||Aug 22, 2022|
|Regulatory Exclusivity Use:||NEW PATIENT POPULATION|
|Patent:||Start Trial||Patent Expiration:||Oct 4, 2032||Product Flag?||Y||Substance Flag?||Delist Request?|
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