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

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)NCT01258803	Phase 2	Completed	Organon and Co	92	2010-12 → 2011-10
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)NCT00383552	Phase 3	Completed	Organon and Co	746	2006-09 → 2008-08
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)NCT01566149	Phase 3	Completed	Organon and Co	49	2012-03 → 2012-09
Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence NCT02045875	Phase 4	Completed	Asthma Management Systems	50	2014-03-04 → 2017-07-12
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)NCT00383240	Phase 3	Completed	Organon and Co	781	2006-09 → 2008-09
Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma NCT00746330	Phase 2	Completed	Novartis	32	2008-08 → 2009-04

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 5 NDCs

Highest NADAC/Unit

$25.26

per gm

Lowest NADAC/Unit

$25.18

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206012602DULERA 200 MCG-5 MCG INHALER	$25.26	GM	Brand	—	2026-08-19
78206012702DULERA 100 MCG-5 MCG INHALER	$25.25	GM	Brand	—	2026-08-19
78206012501DULERA 50 MCG-5 MCG INHALER	$25.19	GM	Brand	—	2026-08-19
78206012701DULERA 100 MCG-5 MCG INHALER	$25.19	GM	Brand	—	2026-08-19
78206012601DULERA 200 MCG-5 MCG INHALER	$25.18	GM	Brand	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$72.02

Highest Price

$344.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0125-01DULERA 50MCG-5MCG	$249.90	Big4	Organon LLC	01/14/2027
78206-0125-01DULERA 50MCG-5MCG	$344.28	FSS	Organon LLC	01/14/2027
78206-0126-01DULERA 200MCG-5MCG	$247.59	Big4	Organon LLC	01/14/2027
78206-0126-01DULERA 200MCG-5MCG	$344.28	FSS	Organon LLC	01/14/2027
78206-0126-02DULERA 200MCG-5MCG	$81.18	Big4	Organon LLC	01/14/2027
78206-0126-02DULERA 200MCG-5MCG	$233.04	FSS	Organon LLC	01/14/2027

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Dulera (2024)

Total Spending

$162.1M

Total Claims

369,910

Beneficiaries

105,783

Avg Cost/Unit

$26.10

Spending Trend

$13.6M(2021)→$100.8M(2022)→$117.0M(2023)→$162.1M(2024)

YoY Change:-3.0%

5yr CAGR:+2.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2025	SUPPL -33	View Letter (PDF)
Aug 13, 2019	SUPPL -26	View Letter (PDF)
Mar 29, 2018	SUPPL -24	View Letter (PDF)
Mar 29, 2018	SUPPL -23	View Letter (PDF)
Dec 27, 2017	SUPPL -22	View Letter (PDF)
Jun 29, 2017	SUPPL -21	View Letter (PDF)
Jul 13, 2016	SUPPL -19	View Letter (PDF)
Dec 29, 2015	SUPPL -18	View Letter (PDF)
Apr 18, 2014	SUPPL -14	View Letter (PDF)
Aug 22, 2013	SUPPL -13	View Letter (PDF)
Aug 1, 2013	SUPPL -11	View Letter (PDF)
Jan 17, 2013	SUPPL -8	View Letter (PDF)
Nov 29, 2012	SUPPL -10	View Letter (PDF)
Nov 29, 2012	SUPPL -7	View Letter (PDF)
Nov 26, 2012	SUPPL -6	View Letter (PDF)
Aug 23, 2012	SUPPL -5	View Letter (PDF)
Aug 22, 2011	SUPPL -2	View Letter (PDF)
Aug 22, 2011	SUPPL -4	View Letter (PDF)
Jun 29, 2010	ORIG -1	View Letter (PDF)

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