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Generated: January 16, 2019

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Details for New Drug Application (NDA): 202450

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NDA 202450 describes TUDORZA PRESSAIR, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the TUDORZA PRESSAIR profile page.

The generic ingredient in TUDORZA PRESSAIR is aclidinium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aclidinium bromide profile page.
Summary for 202450
Tradename:TUDORZA PRESSAIR
Applicant:Astrazeneca Pharms
Ingredient:aclidinium bromide
Patents:8
Generic Entry Opportunity Date for 202450
Generic Entry Date for 202450*:
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: 202450
Mechanism of ActionCholinergic Antagonists
Suppliers and Packaging for NDA: 202450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450 NDA AstraZeneca Pharmaceuticals LP 0310-0800 0310-0800-39 1 POUCH in 1 CARTON (0310-0800-39) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER
TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450 NDA AstraZeneca Pharmaceuticals LP 0310-0800 0310-0800-60 1 POUCH in 1 CARTON (0310-0800-60) > 1 INHALER in 1 POUCH > 60 INHALANT in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrength0.4MG/INH
Approval Date:Jul 23, 2012TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 7, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:LONG-TERM, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:➤ Sign UpPatent Expiration:Jul 7, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS
Patent:➤ Sign UpPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS

Expired US Patents for NDA 202450

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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