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NDA

AZELASTINE HYDROCHLORIDE | N022203 | VIATRIS SPECIALTY LLC

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

5 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer HealthCare LLC et al v. Aurobindo Pharma Ltd. et al 1:2024cv00399	D. Del.	2024-03-28	Terminated 2024-05-23	—
Bayer Healthcare LLC et al v. Amneal Pharmaceuticals LLC et al 1:2021cv01770	D. Del.	2021-12-17	Terminated 2022-08-05	—
Bayer Healthcare LLC et al v. Apotex Inc. et al 1:2021cv01429	D. Del.	2021-10-07	Terminated 2022-12-09	—
MEDA PHARMACEUTICALS INC. v. AUROBINDO PHARMA LIMITED et al 3:2019cv05501 3 patentsANDA 212775azelastine hydrochloride	D.N.J.	2019-02-12	Terminated 2019-08-02	—
Meda Pharmaceuticals Inc. v. Akorn, Inc. et al 1:2017cv00439	D. Del.	2017-04-19	Terminated 2017-07-27	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

35 trials from ClinicalTrials.gov, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies NCT00740792	Phase 3	Completed	Meda Pharmaceuticals	776	2008-08 → 2008-11
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies NCT00660517	Phase 3	Completed	Meda Pharmaceuticals	607	2007-12 → 2008-04
DYmista NAsal Spray in CHInese Patients NCT03599791	Phase 3	Completed	MEDA Pharma GmbH & Co. KG	900	2018-06-29 → 2019-09-24
A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis NCT00720382	Phase 3	Completed	Meda Pharmaceuticals	703	2007-03 → 2008-07
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid NCT00845195	Phase 4	Completed	Alcon Research	150	2009-03
Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis NCT01470053	Phase 3	Completed	Hanlim Pharm. Co., Ltd.	347	2011-03 → 2012-11
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies NCT00883168	Phase 3	Completed	Meda Pharmaceuticals	1,791	2009-04 → 2009-07
Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays NCT01194622	Phase 1	Completed	MEDA Pharma GmbH & Co. KG	30	2010-08 → 2010-10
A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies NCT00720278	Phase 3	Completed	Meda Pharmaceuticals	526	2007-08 → 2007-11
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis NCT00772304	Phase 4	Completed	Alcon Research	102	2008-10

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

API Supply Chain9 active DMFs2 inactive

9 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

ZHEJIANG LEPU PHARMACEUTICAL CO LTDAZELASTINE HYDROCHLORIDE, USP

DMF 367482022

CIPLA LTDInactiveAZELASTINE HYDROCHLORIDE BP/PH.EUR

DMF 201862008

JIANGSU HENGRUI MEDICINE CO LTDInactiveAZELASTINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 256262011

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jun 29, 2021	SUPPL -18	View Letter (PDF)
Sep 12, 2018	SUPPL -15	View Letter (PDF)
Feb 24, 2015	SUPPL -10	View Letter (PDF)
Feb 24, 2015	SUPPL -11	View Letter (PDF)
Sep 4, 2013	SUPPL -8	View Letter (PDF)
Jan 25, 2011	SUPPL -6	View Letter (PDF)
Nov 24, 2009	SUPPL -3	View Letter (PDF)
Oct 22, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Oct 15, 2008

Patents (1)

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

#002 — 0.2055MG/SPRAY

1 patent0 exclusivities▾

SPRAY, METERED;NASAL | Approved: Aug 31, 2009