Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 15, 2019

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 Circassia and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the aclidinium bromide profile page.
Summary for 202450
Tradename:TUDORZA PRESSAIR
Applicant:Circassia
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 POWDER, METERED 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 POWDER, METERED 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:  See PricingPatent Expiration:Jul 7, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:  See PricingPatent Expiration:Jul 7, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:  See PricingPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Expired US Patents for NDA 202450

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   See Pricing   See Pricing
Circassia TUDORZA PRESSAIR aclidinium bromide POWDER, METERED;INHALATION 202450-001 Jul 23, 2012   See Pricing   See Pricing
>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 verifification 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.