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ASTEPRO ALLERGY

NDA

AZELASTINE HYDROCHLORIDE | N213872 | BAYER HEALTHCARE CONSUMER CARE

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayIPRPTAB Challenge

2027

2028

Today

8071073

Jun. 4, 2028IPR

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2014-00731	8071073	IPR	Impax Laboratories, Inc.	Institution Denied	2014-05-07	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Healthcare LLC et al v. Aurobindo Pharma Ltd. et al 1:2021cv01575 3 patentsANDA 216561azelastine hydrochloride	D. Del.	2021-11-05	Terminated 2022-10-24	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

EVONIK OPERATIONS GMBHAZELASTINE HYDROCHLORIDE

DMF 154402001

DAITO PHARMACEUTICAL CO LTDAZELASTINE HYDROCHLORIDE DAITO USP

DMF 183982005

CURIA ITALY SRLAZELASTINE HYDROCHLORIDE

DMF 194222006

ESTEVE QUIMICA SAAZELASTINE HYDROCHLORIDE

DMF 224272009

ZYDUS LIFESCIENCES LTDAZELASTINE HYDROCHLORIDE

DMF 229192009

KOREA UNITED PHARMACEUTICALS INCAZELASTINE HYDROCHLORIDE

DMF 243172010

MSN LABORATORIES PRIVATE LTDAZELASTINE HYDROCHLORIDE USP [ROUTE CODE - "AH"]

DMF 253562011

CORAL DRUGS PRIVATE LTDAZELASTINE HYDROCHLORIDE USP

DMF 362052021

CIPLA LTDInactiveAZELASTINE HYDROCHLORIDE BP/PH.EUR

DMF 201862008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2025	SUPPL -5	View Letter (PDF)
Nov 21, 2023	SUPPL -4	View Letter (PDF)
Jan 19, 2022	SUPPL -1	View Letter (PDF)
Jun 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.2055MG/SPRAY

RLD

1 patent0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jun 17, 2021

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8071073	Jun 4, 2028	—	—	Yes	—	—

#002 — 0.2055MG/SPRAY

RLD

1 patent0 exclusivities▾

SPRAY, METERED;NASAL | Approved: Jun 17, 2021