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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 208294


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NDA 208294 describes BEVESPI AEROSPHERE, which is a drug marketed by Astrazeneca 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 BEVESPI AEROSPHERE profile page.

The generic ingredient in BEVESPI AEROSPHERE is formoterol fumarate; glycopyrrolate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; glycopyrrolate profile page.
Summary for 208294
Tradename:BEVESPI AEROSPHERE
Applicant:Astrazeneca
Ingredient:formoterol fumarate; glycopyrrolate
Patents:7
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208294
Generic Entry Date for 208294*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 208294
Suppliers and Packaging for NDA: 208294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294 NDA AstraZeneca Pharmaceuticals LP 0310-4600 0310-4600-12 120 AEROSOL, METERED in 1 INHALER (0310-4600-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.0048MG/INH;0.0090MG/INH
Approval Date:Apr 25, 2016TE:RLD:Yes
Patent:⤷  Sign UpPatent 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:⤷  Sign UpPatent Expiration:May 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:⤷  Sign UpPatent 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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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.