Azelastine hydrochloride - Generic Drug Details

What are the generic drug sources for azelastine hydrochloride and what is the scope of freedom to operate?

Azelastine hydrochloride is the generic ingredient in ten branded drugs marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, Norvium Bioscience, Mylan Speciality Lp, Bayer Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Sciegen Pharms Inc, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in thirty-three NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride has fifty patent family members in twenty-four countries.

There are nine drug master file entries for azelastine hydrochloride. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for azelastine hydrochloride

International Patents:	50
US Patents:	5
Tradenames:	10
Applicants:	20
NDAs:	33
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	46
Patent Applications:	3,045
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azelastine hydrochloride
What excipients (inactive ingredients) are in azelastine hydrochloride?	azelastine hydrochloride excipients list
DailyMed Link:	azelastine hydrochloride at DailyMed

Recent Clinical Trials for azelastine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
MEDA Pharma GmbH & Co. KG	Phase 2
Sandoz	Phase 1
Nanjing University of Chinese Medicine	N/A

See all azelastine hydrochloride clinical trials

Generic filers with tentative approvals for AZELASTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		205.5MCG	SPRAY;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for azelastine hydrochloride

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for azelastine hydrochloride

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CHILDREN'S ASTEPRO ALLERGY	Nasal Spray	azelastine hydrochloride	205.5 mcg/spray	213872	1	2021-07-12
ASTEPRO	Nasal Spray	azelastine hydrochloride	205.5 mcg/spray	022203		2011-12-15
OPTIVAR	Ophthalmic Solution	azelastine hydrochloride	0.05%	021127	1	2006-12-13
ASTELIN	Nasal Spray	azelastine hydrochloride	0.125 mg base/spray	020114	1	2005-11-14

US Patents and Regulatory Information for azelastine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes	8,518,919
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No	9,919,050		Y
Gland Pharma Ltd	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	210092-001	Feb 25, 2020	AT	RX	No	No
Amneal	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	216576-001	Jun 5, 2024		OTC	No	No
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No	8,071,073		Y

Expired US Patents for azelastine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	5,164,194
Norvium Bioscience	ASTELIN	azelastine hydrochloride	SPRAY, METERED;NASAL	020114-001	Nov 1, 1996	5,164,194*PED
Norvium Bioscience	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	5,164,194*PED

International Patents for azelastine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Denmark	2522365
Denmark	2486942
European Patent Office	2486942	COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)
Denmark	2377557
Lithuania	2486942

Supplementary Protection Certificates for azelastine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
0316633	99C0012	Belgium		PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731	C300740	Netherlands		PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Azelastine hydrochloride Market Analysis and Financial Projection Experimental

Azelastine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The Azelastine Hydrochloride market is experiencing a period of significant growth, driven by increasing demand for effective treatments for allergic conditions such as seasonal and perennial allergic rhinitis.

Market Size and Growth Projections

• The Azelastine Hydrochloride market has seen substantial growth in recent years and is anticipated to continue this trend. By 2031, the market is expected to reach a value significantly higher than its current standing, with forecasts indicating robust growth rates throughout the forecast period[1][4].

Segmentation and Key Markets

By Type

• The market is segmented into various types, including sprays, tablets, and other formulations. Nasal sprays, such as Astelin and Astepro, are particularly prominent due to their efficacy and convenience[1][2].

By Application

• The primary applications of Azelastine Hydrochloride are in treating seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Its effectiveness in these areas has contributed significantly to its market growth[1][2].

Geographical Regions

• The market is geographically divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America is a key player, driven by high awareness about allergy management and a proactive healthcare approach[1][3].

Drivers of Market Growth

Increasing Prevalence of Allergic Conditions

• The rising prevalence of allergic rhinitis and other allergy disorders globally is a major driver of the Azelastine Hydrochloride market. This increase in demand for effective treatment options fuels market expansion[4].

Advances in Medication Delivery

• Innovations in medication delivery methods, such as the development of nasal sprays and eye drops, have enhanced the accessibility and convenience of Azelastine Hydrochloride, contributing to its growing market[4].

Growing Senior Population

• The increasing senior population, which is more susceptible to allergy conditions, also contributes to the expanding market size[4].

Market Dynamics

Competition Analysis

• The market is characterized by a dynamic competitive landscape. Major players are continuously innovating and expanding their product lines to meet the increasing demand for antihistamine solutions[1][3].

Regulatory Environment

• Regulatory approvals and compliance with acts such as the Pediatric Research Equity Act have been crucial in the development and marketing of Azelastine Hydrochloride products. For instance, Meda Pharmaceuticals has fulfilled all the Pediatric Research Equity Act requirements for Astepro Nasal Spray[2].

Financial Trajectory

Revenue Projections

• The Azelastine Hydrochloride market is projected to achieve significant revenue growth from 2023 to 2031. The market size is expected to increase substantially, reflecting the robust growth rates anticipated during this period[1][4].

Market Valuation

• The overall valuation of the Azelastine Hydrochloride market is set to rise significantly, driven by the increasing demand for antihistamine treatments and the expanding use of Azelastine Hydrochloride in various formulations[1][4].

Key Statistics

• The Human Antihistamine Drug Market, which includes Azelastine Hydrochloride, is expected to grow at a CAGR of 9.9% from 2024 to 2033, reaching a market size of approximately USD 706.2 million by 2033[3].

• Second-generation antihistamines, such as Azelastine Hydrochloride, hold over 62.7% of the market share in 2023, emphasizing their improved safety profiles and reduced sedative effects[3].

Regional Analysis

• North America is a leading region in the Azelastine Hydrochloride market, driven by factors such as increased awareness about allergy management, a high incidence of allergic conditions, and a proactive approach to healthcare[1][3].

Challenges and Opportunities

Challenges

• Despite the growth, the market faces challenges such as the potential for side effects like bitter taste and somnolence, which can be mitigated through proper dosing techniques[5].

Opportunities

• The combination of Azelastine Hydrochloride with other medications, such as fluticasone propionate nasal spray, offers opportunities for enhanced efficacy in treating moderate-to-severe rhinitis[5].

"Azelastine is an effective, rapid-acting, and well-tolerated second-generation antihistamine that improves nasal symptoms associated with SAR and VMR."[5]

Conclusion

The Azelastine Hydrochloride market is poised for significant growth, driven by increasing demand for effective antihistamine treatments, advances in medication delivery, and a growing senior population. The market's financial trajectory indicates robust revenue growth and expanding market valuation through 2031.

Key Takeaways

• The Azelastine Hydrochloride market is expected to grow substantially from 2023 to 2031.
• Nasal sprays are a dominant form of Azelastine Hydrochloride due to their efficacy and convenience.
• North America is a key region in the market, driven by high awareness and proactive healthcare approaches.
• The market faces challenges such as side effects but also presents opportunities for combination therapies.
• Second-generation antihistamines, including Azelastine Hydrochloride, hold a significant market share due to their improved safety profiles.

FAQs

Q: What are the primary applications of Azelastine Hydrochloride?

A: The primary applications of Azelastine Hydrochloride are in treating seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR)[1][2].

Q: Which region is leading in the Azelastine Hydrochloride market?

A: North America is the leading region in the Azelastine Hydrochloride market, driven by high awareness about allergy management and a proactive healthcare approach[1][3].

Q: What are the key drivers of the Azelastine Hydrochloride market growth?

A: The key drivers include the increasing prevalence of allergic conditions, advances in medication delivery, and the growing senior population[4].

Q: What are the common side effects of Azelastine Hydrochloride?

A: Common side effects include bitter taste and somnolence, which can be mitigated through proper dosing techniques[5].

Q: How does Azelastine Hydrochloride compare with other antihistamines?

A: Azelastine Hydrochloride is a second-generation antihistamine with improved safety profiles and reduced sedative effects, making it a preferred option[3][5].

Sources

1. Market Research Intellect: Azelastine Hydrochloride Market Size, Scope And Forecast Report[1].
2. FDA: 22203 Azelastine Clinical PREA[2].
3. Market.US: Human Antihistamine Drug Market Size | CAGR OF 9.9%[3].
4. Verified Market Research: In-Depth Industry Outlook: Azelastine Market Size & Forecast[4].
5. PubMed: Azelastine hydrochloride: a review of pharmacology[5].