You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

PENNTUSS Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Penntuss patents expire, and when can generic versions of Penntuss launch?

Penntuss is a drug marketed by Fisons and is included in one NDA.

The generic ingredient in PENNTUSS is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for PENNTUSS?
  • What are the global sales for PENNTUSS?
  • What is Average Wholesale Price for PENNTUSS?
Summary for PENNTUSS
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PENNTUSS at DailyMed
Drug patent expirations by year for PENNTUSS

US Patents and Regulatory Information for PENNTUSS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fisons PENNTUSS chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018928-001 Aug 14, 1985 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 PENNTUSS

Last updated: March 22, 2026

What is the current market position of PENNTUSS?

PENNTUSS is an over-the-counter (OTC) cough suppressant containing diphenhydramine, marketed primarily for relief of cough and cold symptoms. It competes within the antihistamine and cough suppressant market segment. The drug's sales are influenced by OTC drug usage trends, seasonal demand, and regulatory approvals.

Key market data:

  • Global OTC cough and cold market size (2022): approximately $25 billion, with forecast annual growth rate (CAGR) of around 4% to 5% until 2027 [1].
  • PENNTUSS market share: estimated at 2.5% within the US OTC cough relief sector, translating to approximately $200 million in annual sales (2022).

What are the primary factors influencing PENNTUSS’s market dynamics?

Regulatory Environment

  • FDA approvals: Considered a safe OTC medication, with no recent changes to its over-the-counter status. The FDA's stance on OTC drugs supports continued sales.
  • Patent status: PENNTUSS has no recent patent protections, making it vulnerable to generic competition.

Competitive Landscape

  • Key competitors: Robitussin, Mucinex, Delsym, and store brands.
  • Market share: Brand-name products hold about 40% of the OTC cough segment, with generics and store brands occupying the remaining 60%. PENNTUSS is classified as a mid-tier brand relying on established distribution channels.

Consumer Preferences

  • Preference shifts towards natural remedies and multi-symptom formulations impact sales.
  • Rising concern over sedative effects of diphenhydramine reduces consumer appeal for some demographics.

Distribution Channels

  • Major channels include drugstores, supermarkets, and online retail platforms.
  • Expansion into e-commerce has grown approximately 10% annually since 2018.

Seasonal Variations

  • Peak sales during cold and flu season (October to March) comprise approximately 60% of annual revenue.
  • Off-season sales fluctuate due to different consumer demand patterns.

What is the projected financial trajectory for PENNTUSS?

Revenue estimates

  • Current revenue (2022): approximately $200 million.
  • Projected growth rate: 2% annually, aligned with the OTC cough and cold market CAGR of 4%, diminished by brand competition and consumer preferences.
  • Forecasted revenue for 2027: ~$236 million.

Cost structure and margins

  • Manufacturing costs: 15-20% of revenue.
  • Marketing and distribution costs: 30% of revenue.
  • Profit margins: approximately 10-12% net margin, influenced by competitive pressures and promotional activities.

Investment considerations

  • No recent patent protection limits the potential for premium pricing.
  • Potential R&D investments could focus on reformulations or new combination products to extend lifecycle.
  • Strategic partnerships with online retailers could enhance market share growth by 1-2% annually.

Risks and opportunities

  • Risks: patent expiration, increasing preference for natural remedies, regulatory changes.
  • Opportunities: expansion into emerging markets, development of multi-symptom formulations, leveraging digital marketing channels.

What strategic actions could influence PENNTUSS’s financial outcomes?

  • Implement targeted marketing campaigns to reinforce brand loyalty.
  • Develop reformulated versions with lower sedative effects.
  • Expand digital presence through social media and e-commerce platforms.
  • Explore licensing agreements for patenting new formulations.

Key Takeaways

  • PENNTUSS operates in a mature, highly competitive OTC market with modest growth prospects.
  • Sales are heavily seasonal, driven by cold and flu trends.
  • Lack of patent protection limits pricing power but maintains steady revenue levels.
  • Growth potential hinges on diversification, product innovation, and enhanced digital distribution.
  • Market risks include changing consumer preferences and regulatory pressures.

FAQs

1. How does PENNTUSS compare to its competitors?
It maintains a mid-tier market position with stable, but not dominant, market share. Competitors with stronger brand recognition and patent protection may outperform it.

2. What impact does patent expiration have on PENNTUSS?
It exposes the product to generic competition, which can erode sales and margins over time.

3. Are there regulatory concerns affecting PENNTUSS?
Currently, no significant changes are expected; the product’s OTC status remains secure.

4. What emerging markets could expand PENNTUSS’s reach?
Asia-Pacific and Latin America hold growth potential due to rising OTC medication demand.

5. How can PENNTUSS's sales increase in the current market environment?
Through product reformulation, expanding online sales channels, and strategic marketing efforts targeting consumers seeking alternatives to sedatives.


References

[1] Statista. (2022). OTC cough and cold market size and forecast. Retrieved from https://www.statista.com/markets/413/137/cough-cold-medicines/

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.