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Generated: October 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208294

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NDA 208294 describes BEVESPI AEROSPHERE, 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 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
Generic Entry Opportunity Date for 208294
Generic Entry Date for 208294*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
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)
BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294 NDA AstraZeneca Pharmaceuticals LP 0310-4600 0310-4600-28 28 AEROSOL, METERED in 1 INHALER (0310-4600-28)

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
Regulatory Exclusivity Expiration:Apr 25, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:May 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN THE LONG-TERM, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:➤ Sign UpPatent Expiration:May 28, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN THE LONG-TERM, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
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Argus Health
Farmers Insurance
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Cipla
US Department of Justice
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