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Last Updated: September 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212122


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NDA 212122 describes BREZTRI AEROSPHERE, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the BREZTRI AEROSPHERE profile page.

The generic ingredient in BREZTRI AEROSPHERE is budesonide; formoterol fumarate; glycopyrrolate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate; glycopyrrolate profile page.
Summary for 212122
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 212122
Generic Entry Date for 212122*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
Dosage:
AEROSOL, 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.

Suppliers and Packaging for NDA: 212122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122 NDA AstraZeneca Pharmaceuticals LP 0310-4616 0310-4616-12 120 AEROSOL, METERED in 1 INHALER (0310-4616-12)
BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122 NDA AstraZeneca Pharmaceuticals LP 0310-4616 0310-4616-28 28 AEROSOL, METERED in 1 INHALER (0310-4616-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.16MG/INH;0.0048MG/INH;0.009MG/INH
Approval Date:Jul 23, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 23, 2023
Regulatory Exclusivity Use:NEW COMBINATION
Patent:⤷  Try it FreePatent Expiration:May 28, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:⤷  Try it FreePatent Expiration:May 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
McKesson
Dow
Johnson and Johnson
Express Scripts

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.