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.
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
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
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: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.0048MG/INH;0.0090MG/INH | ||||
| Approval Date: | Apr 25, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 28, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 28, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 28, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
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