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NDA

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

2 strengths6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Dec. 23, 2030

Dec. 23, 2034

Dec. 23, 2030

Dec. 23, 2030

Dec. 23, 2030

Dec. 23, 2030

May. 14, 2029

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

6 patents1 exclusivity▴

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

Patents (6) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10159645	Dec 23, 2030	—	—	Yes		—
10617638	Dec 23, 2034	—	—	Yes		—
10806701	Dec 23, 2030	—	—	Yes	—	—
11389401	Dec 23, 2030	—	—	Yes	—	—
11590074	Dec 23, 2030	—	—	—		—
12357568	Dec 23, 2030	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
NP	May 14, 2029	Active

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

RLD

6 patents1 exclusivity▾

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