Viewing data from:

DUAKLIR PRESSAIR

NDA

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE | N210595 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

Today

10085974

Mar. 13, 2029

11000517

Mar. 13, 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

Medicare Part D Spending

CMS annual spending data for Duaklir Pressair (2023)

Total Spending

$49K

Total Claims

Beneficiaries

Avg Cost/Unit

$363.07

Spending Trend

$28K(2019)→$429K(2020)→$347K(2021)→$70K(2022)→$49K(2023)

YoY Change:-63.9%

5yr CAGR:-22.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 1, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4MG/INH;0.012MG/INH

RLD

2 patents0 exclusivities▴

POWDER, METERED;INHALATION | Approved: Mar 29, 2019

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10085974	Mar 13, 2029	—	—	Yes		—
11000517	Mar 13, 2029	—	—	Yes		—