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Generated: December 16, 2017

DrugPatentWatch Database Preview

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 six 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:1
Applicant:1
Ingredient:1
Patents:6

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrength0.4MG/INH
Approval Date:Jul 23, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 23, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Aug 7, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jul 16, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS

Expired Orange Book Patents for NDA: 202450

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PharmsTUDORZA PRESSAIRaclidinium bromidePOWDER, METERED;INHALATION202450-001Jul 23, 2012► Subscribe► Subscribe
Astrazeneca PharmsTUDORZA PRESSAIRaclidinium bromidePOWDER, METERED;INHALATION202450-001Jul 23, 2012► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

McKesson
Chubb
UBS
Boehringer Ingelheim
Express Scripts
Medtronic
Deloitte
Merck
QuintilesIMS
Dow

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