Viewing data from:

DYMISTA

NDA

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE | N202236 | MYLAN SPECIALTY LP

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)TodayPED (+6 mo)IPRPTAB Challenge

Today

8168620

Aug. 24, 2026IPR×2

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2020-00369	8168620	IPR	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	Institution Denied	2020-01-31	—
IPR2017-00807	8168620	IPR	Argentum Pharmaceuticals LLC	Terminated-Settled	2017-02-02	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
MP-AzeFlu Allergen Chamber - Onset of Action Study NCT03004131	Phase 4	Completed	MEDA Pharma GmbH & Co. KG	82	2017-01-07 → 2017-03-29
Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)NCT01915823	Phase 3	Completed	Meda Pharmaceuticals	348	2013-07
Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis NCT02230696	Phase 3	Completed	Padagis LLC	951	2014-08 → 2015-02
Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™NCT02249663	Phase 3	UNKNOWN	Teva Pharmaceuticals USA	1,535	2014-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$9.14

per gm

Lowest NADAC/Unit

$2.32

per gm

Brand NDCs

Generic NDCs

Avg Brand: $9.14

Avg Generic: $2.32

75% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00037024523DYMISTA NASAL SPRAY	$9.14	GM	Brand	$2.32	2026-06-17
00378345823AZELASTIN-FLUTIC 137-50 MCG SPR	$2.32	GM	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$87.98

Highest Price

$158.94

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00037-0245-23DYMISTA 0.15% NASAL SPRAY	$158.94	FSS	Mylan Specialty L.P.	01/14/2027
00037-0245-23DYMISTA 0.15% NASAL SPRAY	$158.94	Big4	Mylan Specialty L.P.	01/14/2027
00378-3458-23AZELASTINE HCL 137MCG/FLUTICASONE 50MCG/SPRAY	$115.31	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-3458-23AZELASTINE HCL 137MCG/FLUTICASONE 50MCG/SPRAY	$87.98	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

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

Medicare Part D Spending

CMS annual spending data for Dymista (2024)

Total Spending

$604K

Total Claims

2,117

Beneficiaries

816

Avg Cost/Unit

$8.63

Spending Trend

$24.1M(2019)→$9.6M(2020)→$2.7M(2021)→$1.9M(2022)→$487K(2023)→$604K(2024)

YoY Change:-7.3%

5yr CAGR:-0.2%

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2024	SUPPL -21	View Letter (PDF)
Apr 19, 2021	SUPPL -13	View Letter (PDF)
Sep 7, 2018	SUPPL -10	View Letter (PDF)
Feb 24, 2015	SUPPL -8	View Letter (PDF)
Aug 17, 2012	SUPPL -1	View Letter (PDF)
May 3, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.137MG/SPRAY;0.05MG/SPRAY

RLDAB

1 patent0 exclusivities▴

SPRAY, METERED;NASAL | Approved: May 1, 2012

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8168620	Feb 24, 2026PED: Aug 24, 2026	PED	—	Yes	—	—