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 nine 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.
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
| Tradename: | BREZTRI AEROSPHERE |
| Applicant: | Astrazeneca Ab |
| Ingredient: | budesonide; formoterol fumarate; glycopyrrolate |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212122
Generic Entry Date for 212122*:
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: 212122
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: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.16MG/INH;0.0048MG/INH;0.009MG/INH | ||||
| Approval Date: | Jul 23, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Oct 5, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 5, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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