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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020828

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NDA 020828 describes FORTOVASE, which is a drug marketed by Hoffmann La Roche and is included in one NDA. There is one patent protecting this drug. Additional details are available on the FORTOVASE profile page.

The generic ingredient in FORTOVASE is saquinavir. There is one drug master file entry for this compound. Additional details are available on the saquinavir profile page.
Summary for 020828
Tradename:FORTOVASE
Applicant:Hoffmann La Roche
Ingredient:saquinavir
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 020828
Generic Entry Date for 020828*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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 020828

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 7, 1997TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 16, 2020Product Flag?Substance Flag?Delist Request?Y

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