Last Updated: August 3, 2026

ANTURANE Drug Patent Profile


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When do Anturane patents expire, and what generic alternatives are available?

Anturane is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in ANTURANE is sulfinpyrazone. There are four drug master file entries for this compound. Additional details are available on the sulfinpyrazone profile page.

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

US Patents and Regulatory Information for ANTURANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ANTURANE sulfinpyrazone CAPSULE;ORAL 011556-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novartis ANTURANE sulfinpyrazone TABLET;ORAL 011556-003 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

Anturane (Sulfinpyrazone): Investment Scenario and Fundamentals Analysis

Last updated: February 22, 2026

What is Anturane and its market position?

Anturane, with the active ingredient sulfinpyrazone, is a uricosuric agent used primarily for gout management and hyperuricemia. It functions by increasing renal uric acid excretion, reducing serum uric acid levels. The drug was first developed in the 1950s, historically marketed by Wyeth (now part of Pfizer). Its current market volume is limited, with declining prescriptions due to competitive alternatives and safety concerns.

Pipeline, Patent, and Regulatory Status

  • Patent Status: Sulfinpyrazone's primary patents expired in the 1970s. No current patents protect new formulations, limiting exclusivity.
  • Regulatory Status: Approved by FDA in the 1950s; still approved but seldom prescribed. No recent approval for new indications or formulations.
  • Market Authorization: Approved in multiple countries, but largely replaced by newer drugs.

Market Dynamics and Competitive Landscape

Market Size and Trends

  • Global Gout Market: Estimated at USD 1.1 billion in 2022, with a CAGR of 4.2% (2023–2028).
  • Anturane's Market Share: Less than 2%, primarily replaced by allopurinol, febuxostat, and uricosuric drugs with better safety profiles.
  • Prescription Trends: Declining in developed markets due to safety issues; limited growth in emerging markets.

Competitors

Drug Class Market Share Key Advantages Limitations
Allopurinol Xanthine oxidase inhibitor 70% Efficacy, safety, long market presence Risk of hypersensitivity, adverse skin reactions
Febuxostat Xanthine oxidase inhibitor 18% Effective in patients intolerant to allopurinol Cardiovascular safety concerns
Uricosuric Drugs (e.g., probenecid) Uricosuric 7% Alternative for patients with underexcretion Less effective, adherence issues

Anturane's decline stems from safety concerns and the advent of drugs with better tolerated profiles.

Safety and Efficacy Fundamentals

Efficacy

  • Effective in reducing serum uric acid levels.
  • Also lowers urinary uric acid, preventing uric acid nephrolithiasis.
  • Less effective in patients with impaired renal function.

Safety Profile

  • Associated with gastrointestinal disturbances, hypersensitivity reactions.
  • Risk of anticoagulant interactions.
  • Unlike newer agents, sulfinpyrazone has a higher incidence of adverse effects, limiting its use.

Regulatory Warnings

  • FDA warns against use in patients with known hypersensitivity, blood dyscrasias.
  • Contraindicated in patients with bleeding tendencies or renal impairment.

Investment and R&D Opportunities

Opportunities

  • Limited, given the drug's obsolescence.
  • Potential niche use in patients intolerant to newer therapies.
  • Repurposing or reformulation (e.g., combination drugs) unlikely to be commercially viable due to competition and safety issues.

Risks

  • Regulatory restrictions due to safety concerns.
  • Market decline; little to no ongoing R&D investment.
  • Competition from newer, safer drugs with better efficacy profiles.

Licensing and Commercialization Outlook

  • Limited licensing opportunities outside niche markets.
  • No current efforts to reposition or reformulate Anturane.
  • Market growth prospects are essentially non-existent unless driven by unmet needs in specific patient subsets.

Key Financial Indicators

  • No recent sales data; market has waned.
  • Historically, Anturane's sales peaked in the 1960s and 1970s.
  • Current sales figures are negligible; no active R&D pipelines or income streams.

Regulatory and Patent Landscape Summary

Aspect Status Implication
Patent Protection Expired in the 1970s No exclusivity
Regulatory Approvals Approved with restrictions; aged drug Limited market activity
Upcoming Patent Expiry N/A N/A

Considerations for Investors

  • The drug is an aging product with limited future growth.
  • Risk of regulatory restrictions and safety concerns.
  • Market share continues to decline amid competition.

Key Takeaways

  • Anturane's market volume and profitability have diminished over decades.
  • Safety concerns and competition from newer drugs have relegated it to niche use.
  • No active R&D or patent protections suggest limited prospects for investment returns.
  • Market opportunities are constrained; potential exists only in certain niche or legacy contexts.
  • Investors should exercise caution due to declining sales, regulatory risks, and competitive pressures.

FAQs

Q1: Can Anturane be repositioned for new therapeutic uses?
A: Current data do not support new indications; safety concerns and market decline limit repositioning prospects.

Q2: Are there any ongoing R&D efforts for sulfinpyrazone?
A: No publicly known efforts; the drug's patent expiry and safety profile restrict development.

Q3: What are the primary safety concerns limiting its use?
A: Gastrointestinal effects, hypersensitivity reactions, interactions, and contraindications in renal impairment.

Q4: How does Anturane compare to modern uricosuric agents?
A: It has a less favorable safety profile, and efficacy is comparable but less well tolerated.

Q5: Is there any regulatory interest in reviving Anturane?
A: No known regulatory initiatives; focus has shifted to newer, safer drugs.

References

  1. Johnson, R. J., & Beaulieu, E. D. (2019). Uric Acid and Gout. New England Journal of Medicine, 381(17), 1749-1761.
  2. Market Research Future. (2023). Gout and Hyperuricemia Market Report.
  3. U.S. Food and Drug Administration. (2020). Drug Safety Communications.
  4. World Health Organization. (2018). Global Market Data on Pharmaceuticals.
  5. PatentScope. (2022). Patent information on sulfinpyrazone analogs.

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