Details for New Drug Application (NDA): 219622
✉ Email this page to a colleague
NDA 219622 describes TRIMBOW, which is a drug marketed by Chiesi 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 TRIMBOW profile page.
The generic ingredient in TRIMBOW is beclomethasone dipropionate; formoterol fumarate; glycopyrrolate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the beclomethasone dipropionate; formoterol fumarate; glycopyrrolate profile page.
The generic ingredient in TRIMBOW is beclomethasone dipropionate; formoterol fumarate; glycopyrrolate. There are twenty drug master file entries for this compound. One supplier is listed 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.
Pharmacology for NDA: 219622
Suppliers and Packaging for NDA: 219622
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIMBOW | beclomethasone dipropionate; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 219622 | NDA | Chiesi USA, Inc. | 10122-120 | 10122-120-02 | 1 CANISTER in 1 CARTON (10122-120-02) / 120 AEROSOL, METERED in 1 CANISTER |
| TRIMBOW | beclomethasone dipropionate; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 219622 | NDA | Chiesi USA, Inc. | 10122-121 | 10122-121-02 | 1 CANISTER in 1 CARTON (10122-121-02) / 120 AEROSOL, METERED in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | 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: | 10,159,645 | Patent Expiration: | Dec 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF ASTHMA | ||||||||
| Patent: | 10,617,638 | Patent Expiration: | Dec 23, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF ASTHMA | ||||||||
Complete Access Available with Subscription
