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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210595

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NDA 210595 describes DUAKLIR PRESSAIR, which is a drug marketed by Circassia and is included in one NDA. There are eleven patents protecting this drug. Additional details are available on the DUAKLIR PRESSAIR profile page.

The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. There is one drug master file entry for this compound. Additional details are available on the aclidinium bromide; formoterol fumarate profile page.
Summary for 210595
Tradename:DUAKLIR PRESSAIR
Applicant:Circassia
Ingredient:aclidinium bromide; formoterol fumarate
Patents:11
Generic Entry Opportunity Date for 210595
Generic Entry Date for 210595*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER, METERED;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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrength0.4MG/INH;0.012MG/INH
Approval Date:Mar 29, 2019TE:RLD:No
Regulatory Exclusivity Expiration:Mar 29, 2022
Regulatory Exclusivity Use:NEW COMBINATION
Patent:  Start TrialPatent Expiration:Jul 7, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:  Start TrialPatent Expiration:Jul 7, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Expired US Patents for NDA 210595

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
Circassia DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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