Viewing data from:

TRIMBOW

NDA

BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE | N219622 | CHIESI FARMACEUTICI SPA

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 18, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.086MG/INH;0.0049MG/INH;0.0106MG/INH

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: May 14, 2026

No patent or exclusivity listings for this strength.

#002 — 0.172MG/INH;0.0049MG/INH;0.0106MG/INH

RLD

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: May 14, 2026

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Chiesi added a new product record (NDA 219622, supplement 002) for Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) in the FDA database.

New: New record

ADDED7/1/2026

TRIMBOW (beclomethasone dipropionate; formoterol fumarate; glycopyrrolate) received FDA approval under NDA 219622 as a combination inhaled corticosteroid, long-acting beta-2 agonist, and long-acting muscarinic antagonist.

New: New record