BECLOMETHASONE DIPROPIONATE - Generic Drug Details

What are the generic drug sources for beclomethasone dipropionate and what is the scope of patent protection?

Beclomethasone dipropionate is the generic ingredient in eleven branded drugs marketed by Glaxosmithkline, Teva Branded Pharm, Norton Waterford, and Schering, and is included in eleven NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Beclomethasone dipropionate has three hundred and twenty-four patent family members in thirty-two countries.

There are seventeen drug master file entries for beclomethasone dipropionate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BECLOMETHASONE DIPROPIONATE

International Patents:	324
US Patents:	20
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	95
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BECLOMETHASONE DIPROPIONATE
What excipients (inactive ingredients) are in BECLOMETHASONE DIPROPIONATE?	BECLOMETHASONE DIPROPIONATE excipients list
DailyMed Link:	BECLOMETHASONE DIPROPIONATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BECLOMETHASONE DIPROPIONATE

Dosage:

AEROSOL, METERED;INHALATION

Dosage:

AEROSOL, METERED;INHALATION

Dosage:

AEROSOL, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BECLOMETHASONE DIPROPIONATE

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

Sponsor	Phase
McMaster University	PHASE4
SGS S.A.	Phase 1
Chiesi Farmaceutici S.p.A.	Phase 1

See all BECLOMETHASONE DIPROPIONATE clinical trials

Generic filers with tentative approvals for BECLOMETHASONE DIPROPIONATE

Applicant	Application No.	Strength	Dosage Form
		0.08MG/INH	AEROSOL, METERED;INHALATION
		0.04MG/INH	AEROSOL, METERED;INHALATION

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 BECLOMETHASONE DIPROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for BECLOMETHASONE DIPROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QVAR REDIHALER	Inhalation Aerosol	beclomethasone dipropionate	80 mcg/actuation	207921	1	2024-07-31
QVAR REDIHALER	Inhalation Aerosol	beclomethasone dipropionate	40 mcg/actuation	207921	1	2023-10-30
QVAR 80	Inhalation Aerosol	beclomethasone dipropionate	40 mcg/actuation and 80 mcg/actuation	020911	1	2020-01-10

US Patents and Regulatory Information for BECLOMETHASONE DIPROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	VANCENASE AQ	beclomethasone dipropionate monohydrate	SPRAY, METERED;NASAL	019589-001	Dec 23, 1987		DISCN	No	No
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No			Y
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y		Y

Expired US Patents for BECLOMETHASONE DIPROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Schering	VANCENASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018521-001	Approved Prior to Jan 1, 1982
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000
Glaxosmithkline	BECLOVENT	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	018153-001	Approved Prior to Jan 1, 1982
Schering	VANCERIL	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	017573-001	Approved Prior to Jan 1, 1982

International Patents for BECLOMETHASONE DIPROPIONATE

Country	Patent Number	Title	Estimated Expiration
Israel	263904
European Patent Office	3582839	INHALATEURS ET PROCÉDÉS ASSOCIÉS (INHALERS AND RELATED METHODS)
Spain	2404818
Hong Kong	1223312	用於吸入器的劑量計數器、吸入器及其軸 (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF)
Serbia	53871

Market Dynamics and Financial Trajectory for Beclometasone Dipropionate

Last updated: September 19, 2025

---

Introduction

Beclometasone dipropionate (BDP) is a corticosteroid widely used in the management of inflammatory and allergic conditions, primarily respiratory diseases such as asthma and allergic rhinitis. Its pharmacological profile, coupled with established safety and efficacy, has underpinned a resilient market presence. This article explores the market dynamics shaping BDP's landscape, analyzes its financial trajectory, and discusses the factors influencing its future outlook amid evolving pharmaceutical industry trends.

---

Pharmacological Profile and Therapeutic Significance

BDP acts as a potent glucocorticoid receptor agonist, reducing airway inflammation and hyperresponsiveness. It is administered via inhalation, primarily in metered-dose inhalers (MDIs) and dry powder inhalers (DPIs). Its therapeutic efficacy in asthma management and allergic rhinitis, coupled with a favorable safety profile, has established its position in both monotherapy and combination formulations.

Market Landscape Overview

The global inhaled corticosteroids (ICS) market, including BDP, is projected to reach approximately USD 12 billion by 2030, driven by rising prevalence of respiratory conditions and expanding indications. BDP's market share remains significant, especially in regions with established healthcare infrastructure such as North America and Europe, but its growth trajectory varies due to competition, regulatory factors, and generics entry.

Key Market Drivers

• Prevalence of Respiratory Diseases: The high global burden of asthma, affecting an estimated 262 million people according to WHO, sustains consistent demand for corticosteroids like BDP.

• Advancements in Delivery Technologies: Innovations in inhaler devices improve drug delivery efficacy, enhance patient compliance, and extend market reach for BDP-based formulations.

• Regulatory Approvals and Patent Strategies: BDP formulations benefiting from regulatory endorsements in major markets, coupled with patent protections or exclusivity periods, drive market profitability.

• Demographic Shifts: Aging populations in developed countries and urbanization in emerging markets contribute to the increasing incidence of respiratory diseases, supporting sustained demand.

Market Challenges and Constraints

• Generic Competition: Patent expirations, especially the loss of exclusivity for some BDP inhalers, introduce generic competition that erodes margins and impacts financial performance.

• Environmental and Regulatory Pressures: Inhalers utilizing hydrofluorocarbon (HFC) propellants are under scrutiny due to environmental concerns. Transitioning to environmentally-friendly inhaler propellants (e.g., hydrofluoroalkane replacements) involves costly reformulations and regulatory hurdles.

• Market Saturation and Brand Loyalty: Well-established brands and formulary preferences can slow adoption of newer or generic BDP inhalers, influencing sales trajectories.

• Emerging Alternatives: The advent of biologics and non-steroidal therapies for resistant cases may impact BDP's market share in specific niches.

Financial Trajectory and Industry Trends

Historical Performance

Historically, BDP has maintained stable revenues in mature markets, underpinned by strong brand recognition and patient adherence facilitated by inhaler device features. Its profitability correlates with inhaler device sales, which comprise an integrated component of the overall value chain.

Market Expansion and Growth Opportunities

Emerging markets offer considerable upside. Urbanization, increased healthcare access, and government initiatives to combat respiratory illnesses underpin potential sales growth. Companies increasingly focus on localized formulations and partnerships to penetrate these markets.

Innovation and Product Pipeline

Innovation in inhaler device technology, such as digitized inhalers with tracking capabilities, enhances treatment adherence and market engagement. Additionally, fixed-dose combination inhalers incorporating BDP with long-acting beta-agonists (LABAs) provide higher-value offerings, boosting financial performance.

Impact of Patent and Regulatory Dynamics

Patent expirations have historically precipitated revenue declines. Companies are investing in reformulations and novel delivery systems to extend exclusivity. Regulatory approvals for new BDP-containing products, including age-specific formulations, can buoy the financial outlook.

COVID-19 Pandemic Influence

The pandemic underscored the importance of respiratory drugs, with increased focus on inhaled corticosteroids as adjuncts in managing COVID-19-associated respiratory complications. This period saw fluctuations in sales, with initial disruptions followed by increased strategic focus on respiratory therapeutics.

Strategic Considerations for Stakeholders

• Brand Positioning: Maintaining strong brand equity through device innovation and patient engagement tools is crucial.

• Market Penetration Strategies: Expanding access via partnership with healthcare providers and formulary inclusions can drive sales, especially in underserved regions.

• R&D Investment: Focusing on novel formulations, delivery systems, and combination therapies can sustain revenue streams.

• Regulatory Navigation: Proactive adaptation to evolving environmental policies and securing approvals for new formulations reinforce market position.

---

Future Outlook and Forecast

The BDP segment is expected to achieve modest compound annual growth rates (CAGR) of 3-4% over the next five years. Factors such as expanding indications, technological advancements, and strategic market expansion support this trajectory. However, the competitive landscape, patent expiries, and environmental regulations represent potential headwinds.

Conclusion

Beclometasone dipropionate remains a cornerstone in respiratory therapeutics, supported by consistent demand driven by the rising burden of asthma and allergy-related conditions. While mature markets exhibit stable revenues, growth prospects lie in emerging markets, formulation innovation, and strategic adaptation to regulatory and environmental changes. The financial outlook hinges on the ability of manufacturers to innovate, penetrate new markets, and sustain brand loyalty amid competitive pressures.

---

Key Takeaways

• Steady Demand: Rising respiratory disease prevalence sustains BDP's core market, especially in mature economies.

• Market Expansion: Emerging markets offer significant growth opportunities, aided by healthcare infrastructure development.

• Innovation Drive: Advances in inhaler technology and combination therapies are crucial to maintaining competitiveness.

• Regulatory and Environmental Challenges: Navigating patent expiries, environmental regulations, and reformulation costs is vital for sustained profitability.

• Strategic Focus: Companies should prioritize R&D, market expansion, and device innovation to capitalize on future growth avenues.

---

FAQs

1. What are the primary therapeutic applications of Beclometasone Dipropionate?
   BDP is mainly used in managing asthma, allergic rhinitis, and other inflammatory respiratory conditions, administered through inhaler formulations.

2. How does patent expiration affect BDP’s market share?
   Patent expiries lead to increased generic competition, often resulting in price reductions and diminished revenues for brand-name formulations.

3. What environmental concerns are associated with BDP inhalers?
   Traditional inhalers using hydrofluorocarbon propellants contribute to global warming; transitioning to eco-friendlier inhalers involves reformulation and regulatory challenges.

4. Which markets are expected to drive the growth of BDP in the future?
   Emerging markets in Asia and Africa are poised for significant growth, fueled by urbanization, increasing healthcare access, and rising disease prevalence.

5. What innovations are shaping the future of BDP formulations?
   Digitized inhalers with adherence tracking, combination therapies, and environmentally sustainable delivery systems are key innovations influencing BDP’s market trajectory.

---

Sources:

[1] World Health Organization, Global Asthma Report 2018.
[2] MarketsandMarkets, Inhaled Corticosteroids Market Analysis, 2022.
[3] IMS Health, Respiratory Disease Therapeutics Trends, 2021.
[4] Environmental Protection Agency, Regulations on HFC Inhalers, 2023.
[5] Pharmaceutical Technology, Innovation in Inhaler Devices, 2022.

---

This comprehensive review provides business professionals with critical insights into the market and financial avenues for Beclometasone Dipropionate, equipping stakeholders to navigate future challenges and capitalize on emerging opportunities.