Details for New Drug Application (NDA): 202450

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NDA 202450 describes TUDORZA PRESSAIR, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. There are four 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:	Covis
Ingredient:	aclidinium bromide
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202450

Generic Entry Date for 202450^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 Action	Cholinergic 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	Covis Pharma US, Inc	70515-002	70515-002-01	1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450	NDA	Covis Pharma US, Inc	70515-002	70515-002-02	1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER, METERED;INHALATION			Strength	0.4MG/INH
Approval Date:	Jul 23, 2012	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 13, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:	⤷ Sign Up	Patent Expiration:	Mar 13, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:	⤷ Sign Up	Patent Expiration:	Apr 22, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202450

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