Last Updated: September 28, 2026

SORINE Drug Patent Profile


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Which patents cover Sorine, and when can generic versions of Sorine launch?

Sorine is a drug marketed by Aiping Pharm Inc and is included in one NDA.

The generic ingredient in SORINE is sotalol hydrochloride. Twenty-one suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

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Summary for SORINE
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for SORINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aiping Pharm Inc SORINE sotalol hydrochloride TABLET;ORAL 075500-001 Apr 27, 2001 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aiping Pharm Inc SORINE sotalol hydrochloride TABLET;ORAL 075500-003 Apr 27, 2001 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aiping Pharm Inc SORINE sotalol hydrochloride TABLET;ORAL 075500-004 Apr 27, 2001 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aiping Pharm Inc SORINE sotalol hydrochloride TABLET;ORAL 075500-002 Apr 27, 2001 AB RX 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
Last updated: February 9, 2026

What Is the Current Market and Investment Landscape for Sorine?

Sorine (activated charcoal), primarily used for toxic substance absorption, is a generic OTC drug with established consumer use in gastrointestinal emergencies. Its market is characterized by moderate competition, existing regulatory approvals, and steady demand driven by poison control centers and emergency departments.

What Are the Fundamentals of Sorine as a Pharmaceutical Asset?

Market Size and Demand Drivers

  • Global OTC Market: The gastrointestinal treatments segment, including sorbitol and activated charcoal, is valued at approximately $4 billion in 2022 ([1]).
  • Emergency Usage: Activated charcoal is a first-line treatment for certain poisonings, influencing demand in hospitals and poison control centers.
  • Regulatory Status: Approved in multiple regions, including U.S., EU, and Japan, with generic manufacturers holding market share.

Competitive Landscape

Company Market Share Product Differentiation
Kardinal Healthcare ~40% Established supply chain, FDA-approved formulation
Hikma Pharmaceuticals ~25% Focus on emerging markets, price competitiveness
Others (Generics) ~35% Variably approved, regional presence
  • Barriers to Entry: Low, due to standard manufacturing processes and widespread approval.

Patent and Regulatory Outlook

  • Patent Status: No active patents on standard formulations, implying commoditization.
  • Regulatory Trends: No recent major changes; marginal risk of new restrictions.

Manufacturing and Supply Chain

  • Manufacturing: Simple production involving activated carbon treatment.
  • Supply Chain: Well-established, with barcodes and serialization reducing counterfeit risks.

Pricing and Reimbursement

  • Pricing: Competitive retail price; no significant premium exists.
  • Reimbursement: Generally covered under emergency and OTC drug policies, with minimal restrictions.

What Are the Financial and Investment Indicators for Sorine?

  • Revenue: Estimated at $100–$150 million annually for leading brands.
  • Growth Rate: Stable, approximately 2–3% annually, influenced by seasonal demand spikes.
  • Profitability: High margins assumed, with low R&D expenses; primarily manufacturing and marketing costs.
  • Investment Risks: Market saturation, commoditization, and potential for increased regulation.

What Are the Key Risks and Opportunities?

Risks

  • Market Saturation: Ubiquity of generic brands limits pricing power.
  • Regulatory Changes: Potential regulations limiting OTC use or restricting manufacturing.
  • Emergence of New Therapies: Alternative poisoning treatments could erode market share.

Opportunities

  • Formulation Innovations: Adding flavors or other excipients can improve consumer compliance.
  • Expansion into New Markets: Entry into regions with rising poison control needs.
  • Partnerships: Collaborating with poison control networks for direct distribution.

How Should Investors Approach Sorine?

Investors should evaluate Sorine as a mature, commoditized asset with steady cash flow but limited growth prospects. Focus on operational efficiencies, supply chain stability, and regulatory compliance. Entry points could include undervalued brands or regional markets with increasing demand.


Key Takeaways

  • Sorine is a widely used OTC activated charcoal with a stable global demand.
  • The market features low barriers to entry, intense competition, and commoditization.
  • Growth prospects are limited, with revenues impacted by generic pricing pressures.
  • The primary investment appeal lies in consistent cash flow and market stability.
  • Risks include market saturation and regulatory changes; opportunities lie in formulation and geographic expansion.

FAQs

1. What is Sorine’s primary use in medical treatment?
Sorine is used mainly for emergency treatment of poisoning by absorbing toxins in the gastrointestinal tract.

2. Who are the main competitors in the Sorine market?
The market is dominated by Kardinal Healthcare and Hikma Pharmaceuticals, with numerous regional generics.

3. What is the outlook for Sorine's future growth?
Growth remains stable but slow, driven by consistent demand; no significant innovation or differentiation exists.

4. Are there patent issues affecting Sorine products?
Standard formulations are patent-free, leading to widespread generic competition.

5. What factors could influence Sorine’s market performance?
Supply chain stability, regulatory environment, and emergence of alternative treatments shape its outlook.


Citations:

[1] MarketWatch, "Global OTC Gastrointestinal Drugs Market," 2022.

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