Last Updated: June 9, 2026

PHRENILIN FORTE Drug Patent Profile


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Which patents cover Phrenilin Forte, and what generic alternatives are available?

Phrenilin Forte is a drug marketed by Valeant and is included in one NDA.

The generic ingredient in PHRENILIN FORTE is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

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Questions you can ask:
  • What is the 5 year forecast for PHRENILIN FORTE?
  • What are the global sales for PHRENILIN FORTE?
  • What is Average Wholesale Price for PHRENILIN FORTE?
Summary for PHRENILIN FORTE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 2
DailyMed Link:PHRENILIN FORTE at DailyMed

US Patents and Regulatory Information for PHRENILIN FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant PHRENILIN FORTE acetaminophen; butalbital CAPSULE;ORAL 088831-001 Jun 19, 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 Phrenilin Forte

Last updated: March 8, 2026

What is Phrenilin Forte?

Phrenilin Forte is an over-the-counter (OTC) medication widely used for headache relief. Its active ingredients include acetaminophen, chlorpheniramine maleate, and codeine phosphate, which address pain, allergy symptoms, and mild cough suppression, respectively. It is primarily marketed in several countries, including India and parts of Southeast Asia.

Market Overview

Market Size and Penetration

  • The global OTC analgesics market was valued at approximately $25 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030 [1].
  • The analgesic segment accounts for about 40% of this market, driven by increased self-medication and aging populations.
  • In India, OTC sales of combination analgesics like Phrenilin Forte comprise an estimated 20–25% of overall headache medication sales [2].

Geographical Distribution

Region Market Share (2022) Growth Rate (2022-2030)
North America 35% 3.8% CAGR
Europe 25% 4.2% CAGR
Asia-Pacific 30% 5.1% CAGR
Latin America 7% 4.5% CAGR
Middle East & Africa 3% 4.3% CAGR

Asia-Pacific demonstrates the highest growth potential, driven by the expanding OTC market and increasing healthcare awareness.

Key Drivers

  • Aging population leading to higher prevalence of headache-related conditions.
  • Increased preference for OTC medications over prescription drugs.
  • Expansion of pharmacy chains and online retail channels.
  • Growing awareness about combination OTC drugs as convenient pain management options.

Competitive Landscape

Major players in OTC analgesics include Johnson & Johnson, GlaxoSmithKline, and local pharmaceutical companies in emerging markets. Phrenilin Forte faces competition from generic formulations and alternative OTC products with similar active ingredients.

Company Market Share (Approx.) Notable Brands
Johnson & Johnson 20% Tylenol, Panadol
GlaxoSmithKline 15% Panadol Osteo
Local Indian firms 30–35% Various generics
Others 10–15% Various regional brands

Market consolidation and strategic marketing affect the competitive positioning of Phrenilin Forte.

Regulatory Environment

  • OTC classification varies by country; in India, Phrenilin Forte is regulated by the Central Drugs Standard Control Organization (CDSCO).
  • Codeine formulation regulations have tightened worldwide due to abuse potential, affecting availability.
  • Some countries have placed restrictions on combination products containing codeine, requiring prescription controls.

Financial Trajectory

Sales Revenue

  • Estimated global sales of Phrenilin Forte approximate $100–150 million annually.
  • Sales growth observed at a CAGR of approximately 5%, reflecting the overall analgesic market trend.
  • In key markets like India, growth exceeds 6% driven by increased OTC consumption and expanding distribution channels.

Cost Structure and Pricing

  • Wholesale price range varies from $0.10 to $0.25 per tablet, depending on local market conditions.
  • Retail prices typically range from $0.50 to $1 per tablet.
  • Margin profiles are high for manufacturers, especially with generic competition.

Revenue Drivers

  • Increased uptake among consumer markets seeking fast relief.
  • Expansion into online retail platforms.
  • New formulations or pack sizes tailored for targeted demographics.

Risks and Challenges

  • Regulatory changes restricting codeine usage could reduce sales.
  • Stringent pharmacy and OTC regulations in North America and Europe may limit market expansion.
  • Competition from non-opioid analgesics and newer formulations.

Emerging Trends

  • Development of non-opioid alternatives to reduce dependency concerns.
  • Introduction of combination products in novel delivery formats.
  • Adoption of direct-to-consumer advertising in select regions.

Market Forecasts

Year Projected Global Sales Growth Rate Notes
2023 ~$120 million 4.8% Continued market expansion
2025 ~$135 million 5.2% Momentum from emerging markets
2030 ~$170 million 4.8% Market saturation levels?

Global sales growth remains steady; however, future increases hinge on regulatory environments and consumer preferences.

Key Takeaways

  • The global OTC analgesic market for drugs like Phrenilin Forte grows driven by demographics, consumer behavior, and OTC sales expansion.
  • In emerging markets, especially Asia-Pacific, double-digit growth potential exists due to rising healthcare awareness.
  • Regulatory policies, especially concerning codeine, represent significant risks; future formulations may need to adapt.
  • Competitive pressures from generics and alternative therapies will influence profit margins and market share.
  • Sales rely heavily on distribution channels, including pharmacies and online portals, with digital commerce expanding rapidly.

FAQs

Q1: How will regulatory restrictions on codeine affect Phrenilin Forte?
A1: Restrictions could limit availability, reduce sales volume, and lead to formulation reformulation to contain non-opioid ingredients.

Q2: Which markets present the highest growth potential?
A2: Asia-Pacific, Latin America, and Middle East regions hold the highest growth due to expanding OTC markets and increasing healthcare awareness.

Q3: What are the main competitors?
A3: Leading competitors include Tylenol (Johnson & Johnson), Panadol (GSK), and numerous regional generics.

Q4: How does pricing affect profitability?
A4: Low wholesale prices are offset by high retail margins; competition and regulation influence pricing strategies.

Q5: What innovation trends are influencing the market?
A5: Development of non-opioid pain relief formulations and expansion of online sales channels are notable.

References

[1] MarketResearch.com. (2022). OTC Analgesics Market Report.
[2] Indian Pharmaceutical Market Data. (2022). Federation of Indian Chambers of Commerce & Industry.

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