ASTEPRO ALLERGY Drug Patent Profile

Which patents cover Astepro Allergy, and what generic alternatives are available?

Astepro Allergy is a drug marketed by Bayer Hlthcare and is included in one NDA. There are three patents protecting this drug.

This drug has fifty patent family members in twenty-four countries.

The generic ingredient in ASTEPRO ALLERGY is azelastine hydrochloride. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Astepro Allergy

A generic version of ASTEPRO ALLERGY was approved as azelastine hydrochloride by APOTEX INC on April 30^th, 2009.

Summary for ASTEPRO ALLERGY

International Patents:	50
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	5
Patent Applications:	1,732
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASTEPRO ALLERGY
What excipients (inactive ingredients) are in ASTEPRO ALLERGY?	ASTEPRO ALLERGY excipients list
DailyMed Link:	ASTEPRO ALLERGY at DailyMed

Recent Clinical Trials for ASTEPRO ALLERGY

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

Sponsor	Phase
University of Chicago	Phase 4
Meda Pharmaceuticals	Phase 4
Novella Clinical	Phase 4

See all ASTEPRO ALLERGY clinical trials

Pharmacology for ASTEPRO ALLERGY

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

US Patents and Regulatory Information for ASTEPRO ALLERGY

ASTEPRO ALLERGY is protected by three US patents.

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
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes	8,071,073		Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes	9,919,050		Y

International Patents for ASTEPRO ALLERGY

See the table below for patents covering ASTEPRO ALLERGY around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1113310	COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF
Hungary	E030388
Turkey	201820559
Serbia	58377	KOMPOZICIJE KOJE SADRŽE AZELASTIN I METODE NJIHOVE UPOTREBE (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)
Lithuania	2522365

Supplementary Protection Certificates for ASTEPRO ALLERGY

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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731	C300740	Netherlands		PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 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

Market Dynamics and Financial Trajectory for Astepro Allergy

Introduction to Astepro Allergy

Astepro Allergy, also known as azelastine, is a steroid-free antihistamine nasal spray used to treat seasonal and perennial allergic rhinitis. It has gained significant attention in recent years due to its efficacy and convenience.

Market Growth Drivers

Rising Prevalence of Allergies

The increasing prevalence of allergies is a major driver for the growth of the Astepro Allergy market. According to the Asthma and Allergy Foundation of America, nearly one-third of American adults and over a quarter of American children suffer from seasonal allergies, eczema, or food allergies each year[1].

Strategic Partnerships and Collaborations

Companies like Bayer, the manufacturer of Astepro Allergy, have engaged in strategic partnerships to enhance market penetration. For instance, in March 2023, Astepro Allergy partnered with Meghann Fahy to raise awareness and help patients suffering from allergies, which is expected to increase the usage and adoption of the product[1].

FDA Approvals and Regulatory Changes

The FDA approval in June 2021 to transition Astepro Allergy from prescription to over-the-counter (OTC) status has significantly expanded its consumer base. This change allows more people to access the medication without a prescription, driving market growth[3].

Market Size and Forecast

Current Market Size

The antihistamine market, which includes Astepro Allergy, is substantial and growing. The global antihistamine market is expected to register a Compound Annual Growth Rate (CAGR) of 7.70% during the forecast period, driven by the rising burden of allergies and stomach disorders[1].

Future Projections

The azelastine market, specifically, is anticipated to rise significantly between 2024 and 2031, fueled by the increasing prevalence of allergic rhinitis and other allergy disorders worldwide. The growing awareness of azelastine’s efficacy and the expanding senior population, which is more susceptible to allergy conditions, contribute to this growth[4].

Regional Market Dynamics

Asia Pacific Region

The Asia Pacific region is expected to play a crucial role in the growth of the azelastine market. Increasing awareness of allergy illnesses, urbanization, environmental pollution, and changing lifestyles in this region are driving the demand for effective allergy treatments like Astepro Allergy. The expanding pharmaceutical industry and improved healthcare access in Asia Pacific also offer considerable potential for market growth[4].

Competitive Landscape

Key Players

Bayer AG, the manufacturer of Astepro Allergy, is a significant player in the antihistamine market. The company’s strategic activities, such as the partnership with Meghann Fahy and the transition of Astepro Allergy to OTC status, have strengthened its position in the market[1][3].

Product Differentiation

Astepro Allergy stands out as the first and only steroid-free antihistamine nasal spray available over-the-counter in the U.S. This differentiation is crucial in addressing unmet consumer needs for allergic rhinitis treatment without the use of steroids or decongestants[2].

Financial Trajectory

Revenue Growth

The global cat allergy market, which includes antihistamines like Astepro Allergy, is expected to grow from USD 3.9 billion in 2021 to USD 5.46 billion by 2028, exhibiting a CAGR of 5.8% during the forecast period. This growth is indicative of the broader antihistamine market trends[3].

Market Challenges

Despite the positive growth trajectory, the market faces challenges such as the patent expiry of branded drugs, the introduction of generic drugs, and adverse effects associated with antihistamine drugs. These factors can impede market growth and affect the financial performance of Astepro Allergy[1].

Adverse Effects and Safety Profile

Clinical Trials

Clinical trials have shown that Astepro Allergy is generally well-tolerated, with common adverse reactions including bitter taste, nasal discomfort, epistaxis, and nasopharyngitis. These reactions are generally mild, and the incidence of severe adverse events is low[5].

Postmarketing Experience

Postmarketing reports have identified additional adverse reactions such as abdominal pain, nasal burning, nausea, and throat irritation. However, these are relatively rare and do not significantly impact the overall safety profile of the drug[5].

Consumer Impact

Convenience and Efficacy

Astepro Allergy offers quick relief from allergy symptoms, starting to work within 30 minutes and providing up to 24 hours of relief. This convenience and efficacy make it a preferred choice for many consumers suffering from seasonal allergic rhinitis[2].

Awareness and Education

The partnership with Meghann Fahy and other awareness campaigns have helped educate consumers about the benefits of Astepro Allergy, increasing its adoption and driving market growth[1].

Key Takeaways

• The Astepro Allergy market is driven by the rising prevalence of allergies and strategic partnerships.
• The transition to OTC status has significantly expanded the consumer base.
• The Asia Pacific region is expected to be a key growth driver due to increasing awareness and healthcare access.
• Despite growth, the market faces challenges from patent expiries and adverse effects.
• Astepro Allergy is generally well-tolerated with a favorable safety profile.

FAQs

1. What is Astepro Allergy used for? Astepro Allergy is used to treat seasonal and perennial allergic rhinitis.

2. What is the significance of Astepro Allergy being available over-the-counter? The OTC status of Astepro Allergy makes it more accessible to consumers without the need for a prescription, expanding its market reach.

3. What are the common adverse effects of Astepro Allergy? Common adverse effects include bitter taste, nasal discomfort, epistaxis, and nasopharyngitis.

4. How does Astepro Allergy differentiate itself in the market? Astepro Allergy is the first and only steroid-free antihistamine nasal spray available over-the-counter in the U.S.

5. What are the growth prospects for the Astepro Allergy market in the Asia Pacific region? The Asia Pacific region is expected to drive significant growth due to increasing awareness of allergy illnesses, urbanization, and improved healthcare access.

Sources

1. Mordor Intelligence - Antihistamine Market Size & Share Analysis - Growth Trends
2. Bayer - FDA Approves Astepro® Allergy Nasal Spray for Over-the-Counter Use in the United States
3. GlobeNewswire - Cat Allergy in Humans Market Size to Grow by USD 5.46 Billion
4. Verified Market Research - In-Depth Industry Outlook: Azelastine Market Size & Forecast
5. FDA - ASTEPRO® Nasal Spray Label[1][2][3][4][5]