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
IPR2017-00807	8168620	IPR	Argentum Pharmaceuticals LLC	Terminated-Settled	2017-02-02	—
IPR2020-00369	8168620	IPR	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	Institution Denied	2020-01-31	—

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Dymista (2023)

Total Spending

$487K

Total Claims

1,752

Beneficiaries

944

Avg Cost/Unit

$9.31

Spending Trend

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

YoY Change:+1.8%

5yr CAGR:+3.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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	—	—