AZELASTINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Azelastine Hydrochloride, and when can generic versions of Azelastine Hydrochloride launch?

Azelastine Hydrochloride is a drug marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, 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 twenty-eight NDAs.

The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azelastine Hydrochloride

A generic version of AZELASTINE HYDROCHLORIDE was approved as azelastine hydrochloride; fluticasone propionate by APOTEX on April 28^th, 2017.

Summary for AZELASTINE HYDROCHLORIDE

US Patents:	0
Applicants:	17
NDAs:	28
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	46
Patent Applications:	1,732
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
Mermaid Medicine®	N/A

See all AZELASTINE HYDROCHLORIDE clinical trials

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
Padagis Israel	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208111-001	Feb 18, 2021	AB	RX	No	No
Apotex	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	216421-002	May 29, 2024		OTC	No	No
Alembic	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209620-001	Mar 20, 2019	AT	RX	No	No
Hikma	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	091444-001	Oct 24, 2014		DISCN	No	No
Upsher Smith Labs	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	202609-001	Mar 17, 2017	AB	RX	No	No
Sun Pharm	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	078738-001	Jun 21, 2010	AT	RX	No	No

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].