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Last Updated: December 18, 2025

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. Eighteen 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

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

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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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parke Davis BENYLIN diphenhydramine hydrochloride SYRUP;ORAL 006514-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BENYLIN

Last updated: August 22, 2025


Introduction

Benylin, a widely recognized pharmaceutical formulation primarily used for cough and cold relief, has established itself as a significant player within the over-the-counter (OTC) medication market. Its unique formulation, market positioning, and regulatory approval status have contributed to a distinctive market dynamic that influences its financial trajectory. This analysis explores the current market landscape, competitive forces, regulatory factors, and financial outlook for Benylin, offering insights relevant to investors, manufacturers, and industry analysts.


Product Overview and Composition

Benylin’s primary active ingredient is usually a combination of centrally acting antitussives (e.g., diphenhydramine or noscapine), decongestants like pseudoephedrine, and sometimes analgesics such as acetaminophen. This formulation targets multiple symptoms — cough suppression, nasal congestion, and body aches — making it a comprehensive OTC remedy for cold and flu symptoms. Its widespread acceptance reflects consumer preference for multi-symptom relief with a single medication.


Market Landscape and Consumer Demand

Global and Regional Market Size

The OTC cough and cold market demonstrates consistent growth, driven by global health awareness, demographic shifts, and increased consumer self-medication. According to recent industry reports, the global OTC drug market is expected to grow at a CAGR of around 4.5% through 2028, with the cough and cold segment representing a significant share (market size estimated at over USD 25 billion in 2022). North America and Asia-Pacific are primary markets due to high consumer demand and expanding healthcare access.

Consumer Preferences and Trends

Increased consumer awareness regarding symptomatic relief options and preference for trusted brands boost sales of established products like Benylin. Moreover, trends toward natural and herbal remedies coexist but do not significantly cannibalize conventional OTC medicines. The pandemic heightened focus on respiratory health, further fueling demand for OTC cold remedies.


Market Dynamics Influencing BENYLIN

Regulatory Environment

Regulatory oversight significantly impacts Benylin’s market stability and expansion potential:

  • Regulatory Approvals: In key markets such as the United States, Benylin’s formulary requires compliance with Food and Drug Administration (FDA) standards, including safety and efficacy verification.
  • Labeling and Restrictions: Some regions impose restrictions on certain ingredients (e.g., pseudoephedrine’s sale regulations due to abuse concerns). These restrictions can affect formulation strategies and sales channels.
  • Generic Competition: Generic formulations approved after patent expiry can pressure pricing, although brand loyalty sustains premium pricing in certain markets.

Competitive Landscape

Benylin faces competition from both multinational pharmaceutical companies and regional players offering similar multi-symptom cold remedies. Notable competitors include:

  • Claritin-D
  • Mucinex
  • Tylenol Cold
  • Local generic brands

Differentiation hinges on formulation, brand perception, distribution reach, and regulatory compliance.

Pricing and Market Penetration

Pricing strategies vary regionally, balancing affordability with brand premium. In mature markets, aggressive discounting and promotional campaigns are used to maintain market share. In emerging markets, regulatory hurdles and income levels influence pricing and access, impacting revenue potential.


Distribution Channels

Benylin’s distribution spans pharmacies, supermarkets, convenience stores, and online platforms. Each channel's influence varies regionally; for example, online OTC sales are rapidly growing in China and Europe, driven by e-commerce expansion. Distribution strategies focusing on multi-channel penetration optimize revenue streams.


Financial Trajectory and Revenue Outlook

Historical Performance

Although comprehensive quantitative data specific to Benylin can be scarce due to proprietary confidentiality, industry benchmarks suggest:

  • Stable Revenue Streams: Due to entrenched brand loyalty and broad consumer acceptance.
  • Profit Margins: Typically high for OTC products owing to low manufacturing costs and minimal regulatory barriers compared to prescription drugs.
  • Growth Factors: Expanding markets, demographic aging, seasonal demand spikes (winter flu season), and product innovation contribute to steady growth.

Forecasted Revenue Growth

Based on industry and regional market analyses:

  • Developed Markets: Moderate CAGR of 3-4%, stabilized by mature consumer base and regulatory constraints.
  • Emerging Markets: Higher growth potential, with CAGR reaching 6-8% as access expands and branding efforts succeed.
  • Impact of Patent and Formulation Changes: Without patent protections, revenue growth relies heavily on brand strength, marketing, and distribution expansion.

Future Investment and R&D

Investment in formulation innovation, such as combining Benylin with natural or additional therapeutic agents, could unlock new markets and extend product lifecycle. Collaborations with online retail platforms are also pivotal in capturing digital-native consumers.


Regulatory and Economic Risks

  • Regulatory Changes: Stricter regulations on sales of pseudoephedrine and other active ingredients could limit product availability or increase compliance costs.
  • Market Competition: Entry of novel formulations or combination products may erode market share.
  • Supply Chain Disruptions: Crises like COVID-19 or geopolitical conflicts could impede raw material supply or distribution networks, affecting sales.

Key Takeaways for Stakeholders

  • Strong Consumer Demand: The sustained demand for multi-symptom OTC cold remedies positions Benylin favorably in both mature and emerging markets.
  • Market Expansion Opportunities: Digital sales and geopolitical shifts offer pathways for revenue growth, with tailored regulatory and marketing strategies.
  • Regulatory Vigilance: Navigating evolving regulatory landscapes is critical to maintaining market access and avoiding compliance costs.
  • Innovation and Brand Loyalty: Continual formulation improvements and brand reinforcement are vital for long-term market dominance and profitability.
  • Competitive Dynamics: Staying ahead of generic entrants and formulation competitors requires strategic patent management and marketing.

Conclusion

Benylin’s market dynamics are characterized by stable demand, regulatory complexities, and intense competitive pressures. Its financial trajectory remains promising, especially with expansion into emerging markets and ongoing product innovation. Stakeholders should emphasize regulatory agility, technological innovation, and strategic marketing to capitalize on growth opportunities. As global healthcare landscapes evolve, Benylin’s ability to adapt will determine its sustained market leadership and profitability.


FAQs

1. What are the primary factors driving Benylin’s market growth?
Growing global awareness of respiratory illnesses, demographic shifts toward aging populations, and increased consumer preference for OTC cold remedies drive demand. Additionally, expansion into emerging markets and the rise of online sales channels bolster growth prospects.

2. How do regulatory challenges impact Benylin’s sales?
Regulations on ingredients like pseudoephedrine can restrict sales channels and formulation options. Stricter labeling, safety standards, and procurement controls can also increase compliance costs and influence product availability.

3. What are the main competitive threats facing Benylin?
Generic formulations, new combination products, and natural remedies pose competition. Technological innovation and brand loyalty remain critical in maintaining market share.

4. How does the emergence of e-commerce affect Benylin’s distribution?
Online platforms facilitate wider and more convenient access, especially in regions like China and Europe. Strategic online marketing and distribution are essential to capture digital-savvy consumers and expand market reach.

5. What strategic actions should manufacturers consider for Benylin’s future?
Investing in formulation innovation, strengthening brand positioning, expanding distribution channels, and navigating regulatory changes proactively will support sustainable growth and financial performance.


Sources:

[1] Market Research Future, "OTC Cold and Cough Market Trends," 2022.
[2] GlobalData, "Pharmaceutical Industry Analysis," 2023.
[3] U.S. Food and Drug Administration, "Regulation of OTC Drugs," 2022.
[4] Statista, "Global OTC Market Size," 2022.

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