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Last Updated: October 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020831

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NDA 020831 describes FORADIL, which is a drug marketed by Novartis and is included in two NDAs. There is one patent protecting this drug. Additional details are available on the FORADIL profile page.

The generic ingredient in FORADIL is formoterol fumarate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 020831
Tradename:FORADIL
Applicant:Novartis
Ingredient:formoterol fumarate
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 020831
Generic Entry Date for 020831*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION

*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 020831

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength0.012MG/INH
Approval Date:Feb 16, 2001TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 28, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

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