EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE Drug Patent Profile

Which patents cover Efidac 24 Pseudoephedrine Hydrochloride/brompheniramine Maleate, and when can generic versions of Efidac 24 Pseudoephedrine Hydrochloride/brompheniramine Maleate launch?

Efidac 24 Pseudoephedrine Hydrochloride/brompheniramine Maleate is a drug marketed by Alza and is included in one NDA.

The generic ingredient in EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE is brompheniramine maleate; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the brompheniramine maleate; pseudoephedrine hydrochloride profile page.

Summary for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE at DailyMed

US Patents and Regulatory Information for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996		DISCN	No	No

Expired US Patents for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996

International Patents for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

See the table below for patents covering EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE around the world.

Country	Patent Number	Title	Estimated Expiration
Italy	8467204
Japan	H0729924
Spain	530268

Market Dynamics and Financial Trajectory for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

Introduction

EFIDAC 24, containing pseudoephedrine hydrochloride and brompheniramine maleate, is a medication used to treat allergy symptoms. To understand its market dynamics and financial trajectory, it is crucial to analyze the broader pharmaceutical landscape, regulatory changes, and the specific impact on this drug.

Regulatory Environment

The regulatory environment plays a significant role in shaping the market dynamics of any pharmaceutical product. In the case of EFIDAC 24, a similar product, Lodrane 24D, manufactured by Elite Pharmaceuticals, faced significant regulatory challenges.

• FDA Actions: In 2011, the FDA announced plans to remove approximately 500 cough, cold, and allergy-related products from the market, including those manufactured by Elite Pharmaceuticals. This action was due to the lack of formal FDA approval for these products. Although EFIDAC 24 is not explicitly mentioned, similar products were affected, indicating potential regulatory hurdles[3].

Market Impact of Regulatory Changes

Regulatory actions can have a profound impact on the financial trajectory of a drug.

• Manufacturing and Sales: Manufacturers must stop producing and shipping affected products within a specified timeframe. For EFIDAC 24, if it were to face similar regulatory issues, this would lead to a significant reduction in sales and revenue.
• Financial Consequences: Elite Pharmaceuticals, for example, saw a substantial portion of its revenue come from products like Lodrane 24D. The inability to manufacture these drugs resulted in a significant adverse effect on their revenues[3].

Competitive Landscape

The competitive landscape in the allergy and cold medication market is highly dynamic.

• Generic and Branded Products: The market is filled with both generic and branded products. Generic versions often gain significant market share due to their lower cost, which can impact the sales of branded products like EFIDAC 24.
• Biosimilar Strategies: Although more relevant to biologic drugs, the trend of adopting biosimilar-only strategies by pharmacy benefit managers (PBMs) indicates a broader shift towards cost-effective alternatives. This could influence the pricing and market share of other medications, including those for allergy symptoms[4].

Financial Performance

To assess the financial trajectory of EFIDAC 24, we need to consider the broader financial trends in the pharmaceutical industry.

• Revenue Streams: For drugs like EFIDAC 24, revenue is primarily generated through sales. Any disruption in manufacturing or sales due to regulatory issues would directly impact revenue.
• Cost Structure: The cost structure includes research and development expenses, manufacturing costs, and general and administrative expenses. Companies like 4D Molecular Therapeutics, which are focused on genetic medicines, highlight the importance of managing these costs to maintain a strong financial position[2].

Case Study: Elite Pharmaceuticals

Elite Pharmaceuticals' experience with Lodrane 24D provides a relevant case study.

• Revenue Impact: The removal of Lodrane 24D from the market resulted in a significant loss of revenue for Elite Pharmaceuticals. In the 9 months ended December 31, 2010, revenues from these products totaled $3.02 million, which was substantially all of Elite’s revenues for the period[3].
• Strategic Adjustments: Elite Pharmaceuticals had to adjust its strategy by developing new products and pursuing FDA approvals for other medications to mitigate the financial impact.

Market Trends and Growth Drivers

Understanding the broader market trends is essential for predicting the financial trajectory of EFIDAC 24.

• Growth in Other Therapeutic Areas: The pharmaceutical market is driven by growth in various therapeutic areas, such as diabetes and cardiovascular diseases. For example, the diabetes market, particularly type 2 diabetes, has seen significant growth driven by new molecules like Mounjaro (tirzepatide)[1].
• Generic and Biosimilar Utilization: The increasing adoption of generic and biosimilar drugs can impact the market share and pricing of branded products. This trend is expected to continue, with significant implications for the financial performance of pharmaceutical companies[4].

Key Takeaways

• Regulatory Compliance: Ensuring regulatory compliance is crucial for maintaining market presence and revenue.
• Market Competition: The competitive landscape, including the rise of generic and biosimilar alternatives, can significantly impact sales and revenue.
• Financial Management: Effective management of costs and diversification of revenue streams are essential for maintaining a strong financial position.
• Market Trends: Understanding broader market trends and growth drivers in the pharmaceutical industry can help predict the financial trajectory of specific drugs.

FAQs

1. What was the impact of FDA actions on similar allergy medications?

   • The FDA's decision to remove unapproved cough, cold, and allergy products from the market resulted in significant revenue losses for manufacturers like Elite Pharmaceuticals.

2. How does the competitive landscape affect EFIDAC 24?

   • The presence of generic and branded competitors, along with the trend towards cost-effective alternatives, can reduce the market share and pricing power of EFIDAC 24.

3. What are the key financial risks for EFIDAC 24?

   • Regulatory issues, competition from generics and biosimilars, and disruptions in manufacturing and sales are significant financial risks.

4. How can pharmaceutical companies mitigate financial risks?

   • Companies can mitigate risks by ensuring regulatory compliance, diversifying their product portfolios, and managing costs effectively.

5. What are the broader market trends affecting pharmaceuticals?

   • Growth in therapeutic areas like diabetes, increasing adoption of generics and biosimilars, and changes in PBM strategies are key trends impacting the pharmaceutical market.

Cited Sources

1. IQVIA, "Finding the growth engines of the endocrine & metabolic ...", October 2023.
2. 4D Molecular Therapeutics, "4DMT Reports First Quarter 2024 Financial Results and Operational Highlights", May 2024.
3. Elite Pharmaceuticals, "FDA to Remove Two Drugs Manufactured by Elite Pharmaceuticals ...", March 2011.
4. Milliman, "Commercial drug trends: 2024 release", July 2024.