Beclomethasone dipropionate - Generic Drug Details

What are the generic 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-seven patent family members in thirty-three countries.

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

Summary for beclomethasone dipropionate

International Patents:	327
US Patents:	20
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	94
Patent Applications:	7,778
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

Constraining patent/regulatory exclusivity:

10,022,510

Dosage:

AEROSOL, METERED;INHALATION

Constraining patent/regulatory exclusivity:

8,132,712

Dosage:

AEROSOL, METERED;INHALATION

Constraining patent/regulatory exclusivity:

7,780,038

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
SGS S.A.	Phase 1
Chiesi Farmaceutici S.p.A.	Phase 1
Mardan Medical Complex	Early 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	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
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	10,022,509		Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	10,695,512		Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No	10,086,156		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No	8,132,712		Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	11,395,889		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No	10,792,447		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No	11,865,247		Y

Expired US Patents for beclomethasone dipropionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	VANCERIL DOUBLE STRENGTH	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020486-001	Dec 24, 1996	4,364,923
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017	7,637,260
Schering	VANCERIL	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	017573-001	Approved Prior to Jan 1, 1982	4,225,597
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982	4,414,209
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012	5,776,432
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	5,605,674
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	5,695,743

International Patents for beclomethasone dipropionate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019145514
South Korea	20160066563
Portugal	4098301
Slovenia	2514467
Portugal	3998096
Hong Kong	1222811
South Korea	101559639

Beclomethasone dipropionate Market Analysis and Financial Projection Experimental

Beclomethasone Dipropionate Market Dynamics and Financial Trajectory

Introduction to Beclomethasone Dipropionate

Beclomethasone dipropionate is a synthetic corticosteroid widely used in the treatment of inflammatory conditions such as asthma, allergic rhinitis, and other respiratory diseases. Its efficacy in controlling symptoms like sneezing, shortness of breath, and nasal congestion has made it a staple in the pharmaceutical industry.

Market Growth Drivers

Increasing Prevalence of Asthma and Allergic Rhinitis

The global beclomethasone dipropionate market is driven primarily by the rising number of asthma and allergic rhinitis cases. People living in industrial areas are more prone to these conditions due to increased exposure to pollutants, which has significantly boosted the demand for beclomethasone dipropionate[1][5].

Population Growth and Urbanization

The growing global population and urbanization trends contribute to the market's expansion. As more people move to urban areas, they are exposed to higher levels of air pollution, increasing the incidence of respiratory diseases and, consequently, the demand for beclomethasone dipropionate[5].

Advancements in Technology and R&D

Pharmaceutical companies are investing heavily in research and development to improve the formulations and delivery systems of beclomethasone dipropionate. These advancements, such as the development of aerosol formulations, have enhanced the drug's efficacy and patient compliance, further driving market growth[3][5].

Economic Factors

The increase in disposable income among consumers and changing lifestyles have also contributed to the market's growth. As people become more health-conscious and have the financial means to seek better healthcare options, the demand for effective treatments like beclomethasone dipropionate increases[5].

Market Restraints

Side Effects and Safety Concerns

Despite its effectiveness, beclomethasone dipropionate is associated with several side effects, which can act as a significant barrier to market growth. These side effects include oral thrush, hoarseness, and potential systemic effects with long-term use, which may deter some patients from using the drug[5].

Financial Trajectory

Market Size and Forecast

The global beclomethasone dipropionate market is anticipated to grow at a significant Compound Annual Growth Rate (CAGR) during the forecast period from 2024 to 2031. The market size is expected to increase substantially, driven by the factors mentioned above. By 2028, the market is projected to reach significant revenue milestones, reflecting its robust growth trajectory[1][5].

Regional Market Analysis

The market is geographically segmented into North America, Europe, Asia Pacific, and the Rest of the world. North America holds a significant share of the market due to the high prevalence of asthma and allergic rhinitis, as well as the strong presence of pharmaceutical companies in the region[5].

Cost-Effectiveness and Economic Evaluations

Studies have shown that combination therapies involving beclomethasone dipropionate, such as the fixed combination with formoterol fumarate, are more cost-effective than using separate inhalers. This cost-effectiveness can lead to higher adoption rates and better health outcomes, further boosting the market's financial performance[2].

Competitive Dynamics

Key Players and Market Share

The beclomethasone dipropionate market is competitive, with several key players vying for market share. Companies are focusing on developing innovative formulations and delivery systems to gain a competitive edge. Market reports provide detailed analyses of these players and their strategies, helping stakeholders understand the competitive landscape[1][3].

Market Segments and Trends

Product Types and Applications

The market is segmented based on product types, including aerosol formulations, oral inhalers, intranasal sprays, and topical creams. Each segment has its own growth potential, with aerosol formulations showing particularly rapid growth due to their ease of use and high efficacy[3].

Technological Advancements

Technological advancements in drug delivery systems, such as the development of metered-dose inhalers (MDIs) and dry powder inhalers (DPIs), are driving the market forward. These advancements improve the drug's bioavailability and patient compliance, contributing to the overall growth of the market[3].

Global Outlook

Future Prospects

The outlook for the beclomethasone dipropionate market remains optimistic, with projections indicating continued significant expansion from 2023 to 2031. The market is expected to benefit from increasing awareness about respiratory health, growing healthcare expenditure, and ongoing research and development activities[3].

Challenges and Opportunities

While the market faces challenges such as side effects and safety concerns, it also presents opportunities for innovation and growth. Pharmaceutical companies can focus on developing safer, more effective formulations and expanding into emerging markets to capitalize on the growing demand for beclomethasone dipropionate[5].

Key Takeaways

• The global beclomethasone dipropionate market is driven by the increasing prevalence of asthma and allergic rhinitis.
• Technological advancements and investments in R&D are key growth drivers.
• The market faces restraints due to side effects and safety concerns.
• The financial trajectory indicates significant growth, with the market expected to reach substantial revenue milestones.
• Regional analysis shows North America holding a significant market share.
• Cost-effectiveness studies highlight the economic benefits of combination therapies.

FAQs

Q: What are the primary drivers of the beclomethasone dipropionate market?

A: The primary drivers include the increasing prevalence of asthma and allergic rhinitis, population growth, urbanization, and advancements in technology and R&D.

Q: Which region holds the largest share of the beclomethasone dipropionate market?

A: North America holds the largest share due to the high prevalence of respiratory diseases and the strong presence of pharmaceutical companies.

Q: What are the potential restraints to the market growth?

A: Side effects and safety concerns associated with beclomethasone dipropionate are significant restraints to market growth.

Q: How does the cost-effectiveness of beclomethasone dipropionate impact the market?

A: Studies have shown that combination therapies involving beclomethasone dipropionate are more cost-effective, leading to higher adoption rates and better health outcomes.

Q: What is the forecasted growth rate of the beclomethasone dipropionate market?

A: The market is anticipated to grow at a significant CAGR during the forecast period from 2024 to 2031.

Sources:

1. OpenPR: Beclomethasone Dipropionate Market 2024| By Key Players.
2. PubMed: Economic evaluation of BDP/formoterol fixed vs two single inhalers.
3. Market Research Intellect: Global Beclomethasone Dipropionate Aerosols Market Size, Trends.
4. Business Research Insights: Inhaler Corticosteroid Device Market Size, Analysis by 2032.
5. Verified Market Research: Beclomethasone Dipropionate Market Size, Share, Trends & Forecast.