VANCERIL DOUBLE STRENGTH Drug Patent Profile

When do Vanceril Double Strength patents expire, and when can generic versions of Vanceril Double Strength launch?

Vanceril Double Strength is a drug marketed by Schering and is included in one NDA.

The generic ingredient in VANCERIL DOUBLE STRENGTH is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.

Summary for VANCERIL DOUBLE STRENGTH

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	1
DailyMed Link:	VANCERIL DOUBLE STRENGTH at DailyMed

Recent Clinical Trials for VANCERIL DOUBLE STRENGTH

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

Sponsor	Phase
Fred Hutchinson Cancer Research Center	Phase 2

See all VANCERIL DOUBLE STRENGTH clinical trials

US Patents and Regulatory Information for VANCERIL DOUBLE STRENGTH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	VANCERIL DOUBLE STRENGTH	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020486-001	Dec 24, 1996		DISCN	No	No

Expired US Patents for VANCERIL DOUBLE STRENGTH

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

International Patents for VANCERIL DOUBLE STRENGTH

See the table below for patents covering VANCERIL DOUBLE STRENGTH around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	134923
Austria	A302275
United Kingdom	1429184

VANCERIL DOUBLE STRENGTH Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vanceril Double Strength

Introduction to Vanceril Double Strength

Vanceril Double Strength is a prescription medication containing the active ingredient beclomethasone dipropionate, a corticosteroid with anti-inflammatory and vasoconstrictive effects. It is used to treat chronic inflammatory processes such as asthma and other respiratory conditions.

Market Status and Regulatory Background

Vanceril Double Strength is marketed by Teva Branded Pharmaceuticals and is available as a metered-dose inhaler (MDI)[2].

Regulatory Approval

The FDA has approved several formulations of beclomethasone dipropionate, including Vanceril and its variants like QVAR RediHaler. These approvals are based on extensive clinical trials that demonstrate the efficacy and safety of these products[5].

Market Size and Growth

Global Respiratory Drug Market

The global market for respiratory drugs, including MDIs like Vanceril Double Strength, is significant and growing. The demand for these medications is driven by increasing prevalence of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD)[1].

Specific Market Dynamics

• Sales Trends: The sales of MDIs in the U.S. have shown a steady increase. Between 2015 and 2018, estimated HFC MDI sales increased by 75%, from 80 million units to 140 million units. This trend is expected to continue with a growth rate of approximately 1% per year through 2025, aligned with population growth and the prevalence of respiratory diseases[1].

Competitive Landscape

The market for MDIs is competitive, with several brands and generic options available. Teva Branded Pharmaceuticals, the manufacturer of Vanceril Double Strength, competes with other major pharmaceutical companies. The competitive landscape is influenced by factors such as pricing, product innovation, and regulatory approvals[2].

Financial Trajectory

Revenue Projections

While specific financial data for Vanceril Double Strength is not readily available, the overall market for MDIs provides a context for revenue projections. The U.S. MDI market, which includes products like Vanceril Double Strength, is expected to grow modestly. The total amount of HFC propellant in MDIs sold in the U.S. is projected to increase, indicating a growing market size[1].

Pricing and Reimbursement

The pricing of Vanceril Double Strength is influenced by factors such as the average manufacturers price (AMP) and Medicaid reimbursement rates. The AMP per unit is gathered from metrics like the National Average Drug Acquisition Costs (NADAC), which helps in determining the wholesale and retail costs of the medication[1].

Key Drivers and Challenges

Increasing Prevalence of Respiratory Diseases

The growing prevalence of asthma and COPD drives the demand for MDIs like Vanceril Double Strength. The prevalence of these conditions has been constant over the past few decades, but the population affected is growing, leading to increased demand for therapeutic options[1].

Regulatory and Environmental Factors

The use of hydrofluorocarbons (HFCs) in MDIs is subject to regulatory scrutiny due to their impact on the environment. However, HFC MDIs are not expected to be completely replaced by non-HFC alternatives in the near future, ensuring a continued market for products like Vanceril Double Strength[1].

Competition and Generic Options

The presence of generic and branded competitors can impact the market share and revenue of Vanceril Double Strength. However, the brand's established reputation and ongoing innovation in delivery systems help maintain its market position[2].

Clinical Efficacy and Safety

Clinical Trials and Approval

The clinical efficacy of Vanceril Double Strength and similar products has been established through multiple clinical trials. These trials have demonstrated the effectiveness of beclomethasone dipropionate in improving lung function and reducing symptoms of asthma and other respiratory conditions[5].

Safety Profile

The safety profile of Vanceril Double Strength is well-documented, with common side effects including throat irritation and cough. The FDA's approval process ensures that the benefits of the medication outweigh the risks, making it a safe option for patients[5].

Conclusion

Vanceril Double Strength operates within a dynamic market driven by the increasing prevalence of respiratory diseases and influenced by regulatory, environmental, and competitive factors. While specific financial data for the product is not available, the overall market trends and the product's established clinical efficacy and safety profile suggest a stable and potentially growing financial trajectory.

Key Takeaways

• Growing Demand: Increasing prevalence of respiratory diseases drives demand for MDIs.
• Regulatory Environment: HFC regulations impact the market but do not immediately threaten HFC-based MDIs.
• Competitive Market: Presence of branded and generic competitors influences market share.
• Clinical Efficacy: Established through multiple clinical trials.
• Safety Profile: Well-documented with common side effects managed through proper use.

Frequently Asked Questions (FAQs)

Q: What is the active ingredient in Vanceril Double Strength? A: The active ingredient is beclomethasone dipropionate, a corticosteroid.

Q: What is the dosage form of Vanceril Double Strength? A: It is available as a metered-dose inhaler (MDI).

Q: Who manufactures Vanceril Double Strength? A: It is manufactured by Teva Branded Pharmaceuticals.

Q: What conditions is Vanceril Double Strength used to treat? A: It is used to treat chronic inflammatory processes such as asthma and other respiratory conditions.

Q: Are there any environmental concerns related to Vanceril Double Strength? A: Yes, the use of HFCs in MDIs like Vanceril Double Strength has environmental implications, but they are not expected to be completely replaced in the near future.

Sources

1. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry.
2. PharmaCompass: VANCERIL DOUBLE STRENGTH.
3. Fact.MR: Vancomycin Market Size, Share Global Trajectory - 2027.
4. ASPE: Antimicrobial Drugs Market Returns Analysis.
5. FDA: QVAR RediHaler/Beclomethasone dipropionate inhalation aerosol.