BECONASE Drug Patent Profile

When do Beconase patents expire, and when can generic versions of Beconase launch?

Beconase is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in BECONASE is beclomethasone dipropionate monohydrate. There are twenty drug master file entries for this compound. Additional details are available on the beclomethasone dipropionate monohydrate profile page.

Summary for BECONASE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	4
Patent Applications:	3,305
Drug Prices:	Drug price information for BECONASE
What excipients (inactive ingredients) are in BECONASE?	BECONASE excipients list
DailyMed Link:	BECONASE at DailyMed

See drug prices for BECONASE

Recent Clinical Trials for BECONASE

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

Sponsor	Phase
West Penn Allegheny Health System	Phase 4
Glaucoma Research Society of Canada	N/A
University Health Network, Toronto	N/A

See all BECONASE clinical trials

US Patents and Regulatory Information for BECONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	BECONASE AQ	beclomethasone dipropionate monohydrate	SPRAY, METERED;NASAL	019389-001	Jul 27, 1987		DISCN	Yes	No

Expired US Patents for BECONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982	4,364,923
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982	4,414,209

International Patents for BECONASE

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1429184
Finland	53067
Belgium	798458

Market Dynamics and Financial Trajectory for BECONASE

Last updated: February 20, 2026

What Is BECONASE?

BECONASE is a nasal spray formulation of beclomethasone dipropionate, a corticosteroid used primarily to treat allergic rhinitis and other nasal inflammatory conditions. The drug is marketed by Teva Pharmaceuticals and has been on the market since the early 1990s.

What Is the Current Market Size and Segment?

• The global allergic rhinitis market was valued at approximately USD 16 billion in 2022.
• BECONASE holds an estimated 4-6% market share within nasal corticosteroids.
• The corticosteroid nasal spray segment represents nearly 70% of allergic rhinitis treatments.

How Is the Market Evolving?

Growth Drivers

• Rising prevalence of allergic rhinitis and nasal inflammatory disorders globally.
• Increased awareness and diagnosis, especially in emerging economies.
• Favorable reimbursement policies in developed markets.

Market Challenges

• Competition from intranasal corticosteroids like Flonase (fluticasone), Nasacort (triamcinolone), and newer biologics.
• Patent expirations leading to generic competition.
• Patient preference shifts toward oral medications in some regions.

Market Share and Competition

Product Name	Active Ingredient	Market Share (2022)	Sales (USD Millions)	Patent Status
BECONASE	Beclomethasone dipropionate	4-6%	250-300	Patent expired in most regions
Flonase	Fluticasone propionate	20%	1,200	Patent expired, generic available
Nasacort	Triamcinolone acetonide	12%	700	Patent expired, generic available
Other	Various	62-64%	Remaining	Multiple

Revenue Trends

• BECONASE's sales peaked in the early 2000s, with annual revenues exceeding USD 500 million.
• Sales declined as generics entered the market post-2010.
• Current revenues stabilized around USD 250-300 million annually, primarily from legacy formulations.

How Do Regulatory and Patent Policies Impact BECONASE?

• The original patent expired in most markets by 2010.
• Patent cliff led to generic competitors flooding the market.
• Regulatory barriers for new formulations limit product innovation.
• Some markets still enforce supplemental patents or regulatory data exclusivity, delaying generic entry.

What Are the Future Financial Trajectories?

Potential Growth Opportunities

• Repurposing BECONASE as a delivery platform for newer anti-inflammatory agents.
• Developing combination nasal sprays with antihistamines.
• Expanding geographic presence in Latin America, Southeast Asia, and Africa.

Risks and Downward Pressures

• Continued generic erosion reduces unit price and overall revenue.
• Competition from biologics and immunotherapies for allergic rhinitis.
• Regulatory changes that favor newer compounds over existing corticosteroids.

Projections

Scenario	Sales Forecast (2023-2027)	Key Assumptions
Conservative	USD 200-250 million	No major repositioning or new formulations. Generic competition intensifies.
Moderate growth	USD 250-300 million	Limited new product development; geographical expansion efforts succeed.
Optimistic	USD 350-400 million	Launch of new combination products or delivery methods.

How Do Pricing and Reimbursement Affect Revenue?

• Price weakening against generics reduces margins.
• Reimbursement policies favor generics, pressuring branded sales.
• In developed markets, formularies prefer low-cost generics, further reducing brand sales.

What Is the Competitive Landscape?

• Dominant brands: Flonase, Nasacort.
• Generic options: multiple approved in key markets like the US, EU, and Japan.
• Emerging biologics and immunotherapies may affect long-term corticosteroid demand.

Key Takeaways

• BECONASE's original patent expired over a decade ago, leading to significant revenue decline.
• The drug operates in a highly competitive, commoditized segment dominated by generics.
• Market expansion hinges on regional penetration and formulation innovation.
• Long-term sales trajectory remains constrained by generic competition, with limited scope for significant growth without product innovation.

FAQs

1. What are the main competitors to BECONASE?

Flonase, Nasacort, and other intranasal corticosteroids dominate the market. Generic versions of these products have reduced BECONASE’s revenue penetration.

2. Can BECONASE regain market share?

Significantly unlikely without reformulation, new delivery methods, or combination therapies. Market trends favor newer biologic options over traditional corticosteroids.

3. How does patent expiration affect BECONASE’s financials?

Patent expiration led to generic competition, reducing sales prices and volumes, constraining revenue growth.

4. What growth strategies could benefit BECONASE?

Expanding into emerging markets, developing new formulations, and entering combination therapies with antihistamines.

5. How do regulatory policies influence BECONASE?

Patent laws and regulatory approval processes limit drug repositioning and delay the launch of improved versions, impacting long-term financial prospects.

References

[1] Grand View Research. (2023). Allergic Rhinitis Market Size & Share Analysis. Retrieved from https://www.grandviewresearch.com

[2] IQVIA. (2022). Global Nasal Spray Market Report.

[3] U.S. Food and Drug Administration. (2022). Patent and Exclusivity Data for Nasal Corticosteroids.

[4] MarketWatch. (2023). Generic Drug Market Trends.