Last Updated: June 17, 2026

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. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

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Questions you can ask:
  • What is the 5 year forecast for BENYLIN?
  • What are the global sales for BENYLIN?
  • What is Average Wholesale Price for BENYLIN?
Summary for BENYLIN
Recent Clinical Trials for BENYLIN

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

SponsorPhase
National Eye Institute (NEI)Phase 1/Phase 2
The EMMES CorporationPhase 1/Phase 2
The Emmes Company, LLCPhase 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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Parke Davis BENYLIN diphenhydramine hydrochloride SYRUP;ORAL 006514-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 BENYLIN

Last updated: April 1, 2026

What Are the Core Market Drivers for BENYLIN?

BENYLIN, an over-the-counter medication primarily used for cough and cold relief, operates in a mature, highly competitive OTC segment. Its market growth is influenced by several key factors:

  • Consumer Demand: Persistence of respiratory illnesses, augmented during cold seasons and pandemics, sustains demand for cough syrups.
  • Brand Recognition: As a well-established OTC brand, BENYLIN benefits from consumer loyalty and brand equity.
  • Distribution Channels: Availability across pharmacies, supermarkets, and online platforms ensures broad accessibility.
  • Competitive Landscape: Major competitors include companies like Johnson & Johnson, Pfizer, and local generic manufacturers; innovation and pricing strategies impact market share.
  • Regulatory Environment: Regulatory approvals and marketing licenses affect product availability and promotional activities.

How Does the Market Size and Growth Potential Look?

The global cough and cold remedy market was valued at approximately USD 13 billion in 2022, with an expected compound annual growth rate (CAGR) of about 3.7% through 2030 ([1]). BENYLIN, predominantly marketed within China, India, and Southeast Asia, contributes significantly to regional OTC markets.

Within China, the OTC cold remedy segment has a size estimated at USD 5 billion in 2021, growing at 4% CAGR. The increasing health awareness and aging population drive persistent demand.

What Is the Competitive Position and Market Share?

While specific sales data for BENYLIN are proprietary, industry estimates suggest:

Region Estimated Market Share Key Competitors
China 15-20% Mucosolvan, Baiyunshan
India 10-15% Benadryl, Dolo-650
Southeast Asia 5-10% Local generics, brands like Decolgen

In China, BENYLIN remains a top-tier OTC cough syrup, with a market penetration exceeding 15% of the segment.

What Are the Key Regulatory and Patent Factors?

  • Regulatory Approvals: Strict compliance with China’s NMPA (National Medical Products Administration) and similar authorities in other markets is mandatory.
  • Patent Status: The core active ingredients, such as dextromethorphan and chlorpheniramine, are off-patent; however, formulation patents or delivery mechanisms can offer exclusivity.
  • Reformulation Trends: Companies innovate with new delivery forms or combination therapies to extend market life.

What Are Revenue Trends and Forecasts?

Historical data indicates:

Year Approximate Global Revenue (USD billion) Growth Rate
2018 10.8 3.5%
2019 11.2 3.7%
2020 12.0 7.1% (COVID boost)
2021 12.6 5.0%
2022 13.0 3.2%

Forecasts predict steady growth following pandemic fluctuations, reaching USD 14.5 billion by 2030 with a CAGR of 3.7% ([1]).

How Are Pricing and Margins Shaping?

Pricing strategies vary by region, with premium pricing in developed markets and competitive pricing in emerging markets. Gross margins for established OTC brands like BENYLIN typically range from 40% to 60%, influenced by manufacturing costs, distribution expenses, and competitive pressures.

What Are the Risks and Opportunities?

  • Risks: Regulatory changes, shifts in consumer preferences, competition from private labels, and supply chain disruptions.
  • Opportunities: Expansion into new markets, product line extensions, digital marketing, and developing formulations for specific demographics like pediatrics or elderly populations.

Final Summary

BENYLIN remains a significant player within the OTC cough and cold remedies sector, supported by regional market growth and brand recognition. The market exhibits stable growth driven by demographic trends and seasonal demand, reinforcing its revenue stability. Competitive positioning depends on innovation, regulatory compliance, and pricing strategies.


Key Takeaways

  • The global OTC cough and cold market is projected to grow at a CAGR of 3.7%, reaching USD 14.5 billion by 2030.
  • BENYLIN maintains a leading regional market share, especially in China and India.
  • Revenue stability depends on regional demand, competition, and regulatory landscape.
  • Margins are moderate, with potential for profit enhancement through product innovation.
  • Risks include regulatory shifts and competitive pressure, while opportunities lie in market expansion and product diversification.

FAQs

1. What active ingredients does BENYLIN contain?
BENYLIN formulations commonly include dextromethorphan, chlorpheniramine, and paracetamol, depending on regional formulations.

2. Is BENYLIN patented?
The active ingredients are off-patent; patent protection may exist for specific formulations or delivery devices.

3. How does regulatory approval impact BENYLIN's market presence?
Regulatory approvals determine product registration and marketing permissions, directly affecting availability and sales.

4. What regional markets hold the highest growth potential for BENYLIN?
Emerging markets such as India, Indonesia, and Southeast Asia offer substantial growth due to expanding middle classes and healthcare awareness.

5. How do pricing strategies influence BENYLIN's profit margins?
Premium pricing sustains margins in developed markets; aggressive pricing in emerging markets supports volume growth but compresses margins.


References

[1] MarketsandMarkets. (2022). Cough and Cold Remedy Market by Type, Distribution Channel, and Region. https://www.marketsandmarkets.com

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