Details for New Drug Application (NDA): 203094
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NDA 203094 describes TYBOST, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TYBOST profile page.
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.
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.
Summary for 203094
| Tradename: | TYBOST |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | cobicistat |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203094
Generic Entry Date for 203094*:
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: 203094
Medical Subject Heading (MeSH) Categories for 203094
Suppliers and Packaging for NDA: 203094
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TYBOST | cobicistat | TABLET;ORAL | 203094 | NDA | Gilead Sciences, Inc. | 61958-1401 | 61958-1401-1 | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| 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: | ⤷ Try a Trial | Patent Expiration: | Apr 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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