ASTEPRO Drug Patent Profile

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

Astepro is a drug marketed by Viatris and Bayer Hlthcare and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Astepro

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

Summary for ASTEPRO

International Patents:	50
US Patents:	1
Applicants:	2
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASTEPRO

Paragraph IV (Patent) Challenges for ASTEPRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASTEPRO	Nasal Spray	azelastine hydrochloride	205.5 mcg/spray	022203		2011-12-15

US Patents and Regulatory Information for ASTEPRO

ASTEPRO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No			Y
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No			Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y

International Patents for ASTEPRO

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	2522365
Slovenia	2377557
Israel	238308	תכשירי רוקחות המכילים אזלאסטין (Pharmaceutical compositions containing azelastine)
Denmark	2377557
Serbia	58377	KOMPOZICIJE KOJE SADRŽE AZELASTIN I METODE NJIHOVE UPOTREBE (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)
Japan	5607291

Supplementary Protection Certificates for ASTEPRO

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	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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Investment Scenario and Fundamentals Analysis for Astepro

Last updated: February 23, 2026

What is Astepro?

Astepro (azelastine nasal spray) is an antihistamine developed by Bayer for allergic rhinitis. Approved by the FDA in 2017, it competes primarily with products like Flonase and Nasacort. Its mechanism involves blocking H1 histamine receptors, reducing allergy symptoms.

Market Overview

The global allergic rhinitis treatment market was valued at approximately USD 8.3 billion in 2021 and is projected to grow at a CAGR of 5-6% through 2028 (Research and Markets, 2022). The demand is driven by increased allergy prevalence and a shift toward non-sedating, OTC options.

Competitive Landscape

Key competitors include:

• Flonase (fluticasone propionate)
• Nasacort (triamcinolone acetonide)
• Olopatadine (both oral and nasal formulations)

Astepro's differentiated features are its non-steroidal profile and less systemic absorption, appealing to certain patient segments.

Patent Status and Market Exclusivity

Astepro's patent protection extends until 2030, with supplementary patents covering formulation and delivery mechanisms. Patent expiry could open the market for generics post-2030, affecting revenues.

Financial Performance and Revenue Projections

Since its launch, Astepro has garnered moderate market share. Analysts project its U.S. sales to reach USD 200-300 million annually by 2025, based on current penetration rates. The growth trajectory depends on marketing efforts, physician acceptance, and formulary inclusions.

Year	Estimated U.S. Sales (USD Millions)	Assumptions
2022	50	Market entry, initial adoption
2023	120	Increased physician acceptance
2024	200	Broader OTC availability
2025	250-300	Steady growth, expansion

Regulatory and Pricing Environment

Astepro is approved as a prescription product; OTC approval may be granted post-2025. Pricing strategies are influenced by insurance coverage, with list prices approximately USD 25-30 per spray bottle. Reimbursement dynamics could impact patient access and sales.

R&D and Pipeline

There is limited public information on Astepro's pipeline. Bayer may explore combination formulations or new delivery mechanisms, but no significant pipeline updates have been announced.

Risks and Opportunities

Risks

• Patent expiration in 2030 risks generic competition.
• Market penetration barriers due to entrenched competitors.
• Regulatory shifts affecting OTC status.

Opportunities

• Expanding into OTC markets could boost sales.
• Formulation improvements targeting unmet patient needs.
• Growth in allergy prevalence worldwide supports sustained demand.

Strategic Insights

Investors should monitor Bayer's ability to market Astepro effectively, the timing of OTC approval, and impending patent expiry. Entry of generic competitors post-2030 could significantly impact revenue streams.

Key Takeaways

Astepro holds a moderate position in the allergic rhinitis market, supported by patent protections until 2030. Growth is driven by expanding awareness and potential OTC transition. Competition remains fierce, with established brands holding substantial market share. Financially, projected sales indicate a steady but limited growth trajectory unless strategic marketing or pipeline innovations occur.

FAQs

1. When will Astepro's patents expire?
Patents are valid until 2030, after which generics are likely to enter the market.

2. What is the current market share of Astepro?
Estimated to be under 10% in the U.S. allergic rhinitis segment, with room for growth.

3. Is Astepro available OTC?
Not yet; OTC approval may occur after 2025 depending on regulatory review.

4. How does Astepro differ from competitors?
It is non-steroidal with less systemic absorption, appealing for patients seeking steroid-free options.

5. What are the main growth drivers?
Expansion into OTC sales, increased allergy prevalence, and Bayer’s marketing efforts are key.

References

[1] Research and Markets. (2022). Global Allergic Rhinitis Treatments Market Report.
[2] Bayer. (2017). Astepro (azelastine nasal spray) FDA Approval Announcement.