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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 210595


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NDA 210595 describes DUAKLIR PRESSAIR, which is a drug marketed by Covis and is included in one NDA. It is available from two suppliers. There are four 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. Two suppliers are listed for this compound. Additional details are available on the aclidinium bromide; formoterol fumarate profile page.
Summary for 210595
Tradename:DUAKLIR PRESSAIR
Applicant:Covis
Ingredient:aclidinium bromide; formoterol fumarate
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Pharmacology for NDA: 210595
Suppliers and Packaging for NDA: 210595
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595 NDA AstraZeneca Pharmaceuticals LP 0310-0900 0310-0900-30 1 POUCH in 1 CARTON (0310-0900-30) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595 NDA AstraZeneca Pharmaceuticals LP 0310-0900 0310-0900-60 1 POUCH in 1 CARTON (0310-0900-60) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrength0.4MG/INH;0.012MG/INH
Approval Date:Mar 29, 2019TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:⤷  Try a TrialPatent Expiration:Apr 22, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 210595

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.