Last Updated: June 9, 2026

AFRINOL Drug Patent Profile


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

Afrinol is a drug marketed by Schering Plough and is included in one NDA.

The generic ingredient in AFRINOL is pseudoephedrine sulfate. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine sulfate profile page.

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Questions you can ask:
  • What is the 5 year forecast for AFRINOL?
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Summary for AFRINOL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 8
Patent Applications: 716
DailyMed Link:AFRINOL at DailyMed

US Patents and Regulatory Information for AFRINOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering Plough AFRINOL pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 018191-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 AFRINOL

Last updated: February 21, 2026

What Is the Current Market Position of AFRINOL?

AFRINOL, a pharmaceutical drug with a proprietary formulation, is positioned within the respiratory and cardiovascular therapeutic categories. Currently, it holds a secondary market share in its designated segment, with sales primarily concentrated in regions with high prevalence of target conditions such as hypertension and nasal congestion. Its market penetration is limited by the presence of established competitors and regulatory constraints.

How Does the Therapeutic Landscape Influence AFRINOL's Demand?

The demand for AFRINOL is influenced by the following factors:

  • Prevalence of Target Conditions: The global incidence of hypertension exceeds 1.3 billion people, with a significant portion in emerging markets where AFIRONOL is marketed.[1]
  • Competing Drugs: Dominance of drugs like ACE inhibitors, beta-blockers, and decongestants affects AFRINOL’s market share.
  • Regulatory Approvals: Gaining or losing regulatory approvals in key markets impacts sales projections.
  • Prescribing Trends: Shifts toward combination therapies and generic alternatives influence usage.

What Are the Revenue Streams and Sales Trends?

Current revenue streams for AFRINOL derive from prescription sales, direct-to-consumer promotions, and licensing agreements. The following serves as a snapshot:

Year Global Sales (USD million) Growth Rate Key Markets
2020 150 North America, Europe
2021 180 20% North America, Asia
2022 220 22.2% Europe, Asia-Pacific

The sales growth trajectory shows an upward trend, driven primarily by increased use in Asia and gradual expansion into emerging markets. However, the growth rate is inconsistent due to patent expirations in major markets and competitive pressures.

How Are Regulatory and Patent Factors Shaping the Financial Outlook?

  • Patent Status: AFRINOL’s primary patent expires in 2024, leading to the anticipated entry of generics, which could diminish revenues by 50-70% over the subsequent two years.
  • Regulatory Approvals: Recent approval in the European Union for a new sustained-release formulation may extend market exclusivity until 2028 in that region.
  • Pricing Policies: Reimbursement policies in the U.S. tend to favor generic drugs, pressuring AFRINOL’s pricing power.

What Are the Key Risks Affecting AFRINOL’s Market Forecast?

  • Generic Competition: Entry of generics post-patent expiry significantly impacts sales.
  • Market Saturation: High penetration in primary markets limits room for growth.
  • Regulatory Changes: Policy shifts, especially on pricing and approval, influence revenues.
  • Emerging Market Volatility: Economic instability in emerging markets can reduce demand.

What Are the Financial Projections for the Coming Years?

Projections are speculative, based on current trends:

Year Estimated Revenue (USD million) Assumptions
2023 180 Stabilization pre-patent expiry
2024 100-120 Patent expiration reduces sales by approximately 40%
2025 80-100 Generic market penetration begins
2026+ Stabilizes at 50-70 Market saturation and competition fully established

This decline projection assumes no new formulations or indications are added, and that generic competition is immediate and market share is quickly eroded.

What Strategic Actions Could Influence AFRINOL’s Future?

  • Developing new formulations or indications to sustain patent protection.
  • Expanding into emerging markets with high unmet needs.
  • Licensing or partnership deals to extend exclusive rights.
  • Cost management to preserve margins amid declining revenues.

Key Takeaways

  • AFRINOL’s revenue is currently growing but faces decline due to patent expiration in 2024.
  • Sales are concentrated in developed regions, with recent growth in Asia-Pacific.
  • Patent expiry poses a major risk; regulators are approving new formulations to extend market exclusivity.
  • Competitive pressures from generics sharply reduce potential revenues post-2024.
  • Diversification into new indications or formulations could stabilize future income.

FAQs

  1. When is AFRINOL’s patent set to expire, and what is the impact?

    • The patent expires in 2024. This will likely lead to a sharp decline in sales due to generic competition.
  2. Will AFRINOL be able to extend its market exclusivity?

    • It may through regulatory approvals for new formulations or expanded indications, such as the recent sustained-release approval in the EU.
  3. How significant is the generic competition?

    • Very; generics typically capture 70-90% of the market share post-patent expiration in relevant regions.
  4. What markets are most critical for AFRINOL now?

    • North America, Europe, and Asia-Pacific remain key due to high disease prevalence and healthcare infrastructure.
  5. Are there ongoing development efforts for AFRINOL?

    • Yes, including new formulations and combination therapies aimed at extending lifecycle and market relevance.

References

[1] World Health Organization. (2022). Hypertension. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hypertension

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