Viewing data from:

DULERA

NDA

FORMOTEROL FUMARATE; MOMETASONE FUROATE | N022518 | ORGANON LLC

3 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

Medicare Part D Spending

CMS annual spending data for Dulera (2023)

Total Spending

$117.0M

Total Claims

252,491

Beneficiaries

70,485

Avg Cost/Unit

$26.92

Spending Trend

$13.6M(2021)→$100.8M(2022)→$117.0M(2023)

YoY Change:+6.1%

5yr CAGR:+4.9%

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

Approval Letters

19 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.005MG/INH;0.1MG/INH

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Jun 22, 2010

No patent or exclusivity listings for this strength.

#002 — 0.005MG/INH;0.2MG/INH

RLD

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: Jun 22, 2010

#003 — 0.005MG/INH;0.05MG/INH

RLD

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: Aug 12, 2019