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Last Updated: December 22, 2024

BENYLIN Drug Patent Profile


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Which patents cover Benylin, and when can generic versions of Benylin launch?

Benylin is a drug marketed by Parke Davis and is included in two NDAs.

The generic ingredient in BENYLIN is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

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Summary for BENYLIN
Drug patent expirations by year for BENYLIN
Recent Clinical Trials for BENYLIN

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

SponsorPhase
The EMMES CorporationPhase 1/Phase 2
The Emmes Company, LLCPhase 1/Phase 2
National Eye Institute (NEI)Phase 1/Phase 2

See all BENYLIN clinical trials

US Patents and Regulatory Information for BENYLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis BENYLIN diphenhydramine hydrochloride; pseudoephedrine hydrochloride SOLUTION;ORAL 019014-001 Jun 11, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis BENYLIN diphenhydramine hydrochloride SYRUP;ORAL 006514-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BENYLIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benylin

Introduction to Benylin

Benylin is a well-known brand in the cough and cold preparations market, particularly recognized for its range of over-the-counter (OTC) medications. To understand the market dynamics and financial trajectory of Benylin, it is crucial to delve into various factors influencing its performance.

Historical Context and Market Impact

After April 1985, when branded cough medicines were no longer available on prescription, Benylin faced a significant challenge. The delisting led to a drastic fall in sales, necessitating a strategic campaign to regain market share and credibility[1].

Advertising and Marketing Strategies

To counter the decline, Benylin implemented targeted advertising campaigns. These campaigns were initially tested in London and Yorkshire for six weeks, resulting in notable sales increases in both areas. The success of these regional campaigns led to a national rollout, which further boosted brand share and sales even as the rest of the market declined[1].

Market Size and Growth

The global cough and cold preparations market, within which Benylin operates, has been growing steadily. In 2023, the market size was approximately $80.96 billion, and it is projected to grow to $85.36 billion in 2024 at a compound annual growth rate (CAGR) of 5.4%. By 2028, the market is expected to reach $104.31 billion, driven by factors such as increased prevalence of respiratory diseases, global warming, and strong economic growth in emerging markets[4].

Segmentation and Competition

The cough and cold preparations market is segmented by type, drug type, dosage type, and distribution channel. Benylin competes in various segments, including bronchodilators, antihistamines, expectorants, and decongestants. The market is also characterized by the presence of other major players, which can impact Benylin's market share and financial performance[4].

Regional Performance

North America was the largest region in the cold and cough preparation market in 2023. However, the Middle East is expected to be the fastest-growing region during the forecast period. Understanding regional dynamics is crucial for Benylin to tailor its marketing and distribution strategies effectively[4].

Regulatory Environment

The market is regulated by authorities such as the Food and Drug Administration (FDA) in the US. For instance, the FDA has restricted the use of codeine in children due to serious health risks. Such regulatory changes can impact the formulation and marketing of Benylin products, necessitating compliance and potential reformulation[4].

Financial Performance and Projections

While specific financial data for Benylin is not readily available, its performance can be inferred from the broader market trends. Successful advertising and marketing campaigns, as seen in the past, can significantly boost sales. However, the financial trajectory also depends on external factors such as competition, regulatory changes, and overall market growth.

Case Study: Advertising Impact

The Benylin case study highlights the effective use of advertising to increase sales and market share. After the delisting from prescription status, targeted campaigns helped Benylin regain its market position. This example underscores the importance of strategic marketing in driving financial performance[1].

Challenges and Opportunities

  • Challenges: The market faces challenges such as high inflation, the impact of global events like the Ukraine-Russia war, and the ongoing effects of COVID-19. These factors can affect consumer spending and market stability.
  • Opportunities: The growing demand for personalized medicines, the rise of generic respiratory drugs, and the increasing popularity of e-cigarettes/vaping present opportunities for innovation and market expansion[4].

Key Takeaways

  • Effective Marketing: Targeted advertising campaigns can significantly impact sales and market share.
  • Regulatory Compliance: Adherence to regulatory changes is crucial for product formulation and marketing.
  • Market Growth: The cough and cold preparations market is expected to grow, driven by various global health and economic factors.
  • Regional Dynamics: Understanding regional market trends is essential for tailored marketing strategies.

FAQs

  1. What was the impact of delisting from prescription status on Benylin sales? The delisting led to a drastic fall in sales, necessitating strategic campaigns to regain market share and credibility[1].

  2. How did Benylin regain its market position after the delisting? Benylin implemented targeted advertising campaigns, which were initially tested in regional areas before a national rollout, resulting in increased sales and market share[1].

  3. What are the key drivers of the cough and cold preparations market? The market is driven by factors such as increased prevalence of respiratory diseases, global warming, and strong economic growth in emerging markets[4].

  4. How does regulatory environment impact Benylin? Regulatory changes, such as those by the FDA, can impact product formulation and marketing, requiring compliance and potential reformulation[4].

  5. What are the projected growth rates for the cough and cold preparations market? The market is expected to grow from $80.96 billion in 2023 to $85.36 billion in 2024 and reach $104.31 billion by 2028 at a CAGR of 5.1%[4].

Cited Sources:

  1. IPA - Benylin: Effective use of advertising to increase sales and market share.
  2. AbbVie - AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
  3. Baron Capital Group - A Multi-Billion-Dollar Drug Market.
  4. The Business Research Company - Cough And Cold Preparations Global Market Report 2024.

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