Details for New Drug Application (NDA): 219622
The generic ingredient in TRIMBOW is beclomethasone dipropionate; formoterol fumarate; glycopyrrolate. There is one drug master file entry for this compound. Additional details are available on the beclomethasone dipropionate; formoterol fumarate; glycopyrrolate profile page.
Summary for 219622
| Tradename: | TRIMBOW |
| Applicant: | Chiesi |
| Ingredient: | beclomethasone dipropionate; formoterol fumarate; glycopyrrolate |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219622
Generic Entry Date for 219622*:
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.086MG/INH;0.0049MG/INH;0.0106MG/INH | ||||
| Approval Date: | May 14, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 14, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF ASTHMA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 23, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF ASTHMA | ||||||||
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