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Generated: November 19, 2018

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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.
Summary for 203094
Tradename:TYBOST
Applicant:Gilead Sciences Inc
Ingredient:cobicistat
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity 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.

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:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 24, 2014TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 4, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 3, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE

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