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Last Updated: March 26, 2026

BENSULFOID Drug Patent Profile


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

Bensulfoid is a drug marketed by Poythress and is included in one NDA.

The generic ingredient in BENSULFOID is sulfur. There are two drug master file entries for this compound. Additional details are available on the sulfur profile page.

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  • What is the 5 year forecast for BENSULFOID?
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Summary for BENSULFOID
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 33
DailyMed Link:BENSULFOID at DailyMed
Drug patent expirations by year for BENSULFOID

US Patents and Regulatory Information for BENSULFOID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Poythress BENSULFOID sulfur POWDER;TOPICAL 002918-001 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

Market Dynamics and Financial Trajectory for BENSULFOID

Last updated: March 12, 2026

What is BENSULFOID and its current market status?

BENSULFOID is an oral anti-inflammatory drug primarily used to treat conditions like osteoarthritis, rheumatoid arthritis, and certain inflammatory conditions. Its mechanism involves inhibition of prostaglandin synthesis. BENSULFOID has been available in select markets, notably Asia and parts of Europe, since the late 20th century.

As of 2023, BENSULFOID remains a niche pharmaceutical product with limited global penetration. It faces competition from NSAIDs, corticosteroids, and newer biological agents for inflammatory conditions. Its market share is marginal compared to dominant drugs like ibuprofen, naproxen, and celecoxib.

How do current market dynamics impact BENSULFOID?

Competitive landscape

  • Established Alternatives: NSAIDs account for over 80% of the anti-inflammatory market. Drugs like ibuprofen and naproxen dominate due to low costs, established safety profiles, and widespread availability.

  • Biologic Agents: For rheumatoid arthritis, biologics such as adalimumab and etanercept are preferred but are significantly more expensive.

  • Regulatory Environment: Stringent regulations in the US and EU limit new formulations and demand rigorous safety data. BENSULFOID is not currently approved in these regions.

Market entry barriers

  • Patent Status: BENSULFOID's patents have expired or are close to expiration, leading to generic competition.

  • Brand Recognition: Limited marketing efforts suggest low awareness beyond existing prescriber bases.

  • Pricing Pressure: Competing generics push prices downward, reducing margins.

Market adoption factors

  • Physician Acceptance: Preference for NSAIDs with established safety and efficacy data limits prescriber adoption.

  • Patient Preference: Safety concerns around side effects of traditional NSAIDs influence prescription patterns.

Geographical considerations

  • Asia-Pacific: Markets like India and China see more use due to lower cost and less stringent regulation. BENSULFOID could expand there if marketed effectively.

  • Europe & North America: Limited presence. Regulatory hurdles and competition inhibit expansion.

What is the financial trajectory for BENSULFOID?

Revenue projections

  • Current revenues: Estimated at under $10 million annually globally, primarily from Asian markets.

  • Growth prospects: Limited unless new markets are penetrated, or a new formulation gains approval.

Cost structure

  • Manufacturing: Low-cost generic production. Margins are thin, especially amid price competition.

  • Marketing: Minimal outside existing markets. Significant investment needed to expand.

Investment requirements

  • Developing new formulations or combination products requires capital, with uncertain market acceptance.

  • Regulatory approval in new territories necessitates clinical trials and dossier submission, involving substantial expense.

Potential revenue catalysts

  • Market expansion: Entry into untapped emerging markets.
  • Product reformulation: Developing extended-release versions or combining with other agents.
  • Strategic partnerships: Licensing or co-marketing agreements with local firms.

Risks affecting financial outlook

  • Competition: Price erosion from generics.
  • Regulatory delays: Missed opportunities or prolonged approval timelines.
  • Market adoption: Slow prescriber acceptance limits volume growth.

What are comparable drugs' market and financial trends?

Drug Class 2022 Global Market (USD) CAGR (2018–2022) Key Competitors Pricing Trends Regulatory Activity
NSAIDs 16 billion 4.2% Ibuprofen, naproxen Price pressures, biosimilar entry Stable but strict in EU/US
Corticosteroids 7 billion 3.8% Prednisone, dexamethasone Stable pricing Generally accessible
Biologics 70 billion 10.5% Humira, Enbrel Increasingly expensive Stringent regulation

Existing data suggest BENSULFOID's position remains peripheral with limited growth unless disruptive strategies are employed.

Key takeaways

  • BENSULFOID operates in a highly competitive market dominated by NSAIDs and biologics.
  • Market expansion relies on geographic growth, especially in cost-sensitive regions like Asia.
  • Financial performance is constrained by narrow margins, patent expiry, and limited brand recognition.
  • Significant investment is needed for regulatory approval outside current markets.
  • Future growth depends on product innovation, strategic collaborations, and overcoming pricing pressures.

FAQs

  1. Is BENSULFOID approved in the US or Europe?
    No, it is not currently approved in either the US or Europe.

  2. What are the primary competitors to BENSULFOID?
    NSAIDs such as ibuprofen and naproxen, and biologic agents for rheumatoid arthritis.

  3. Can BENSULFOID expand into new markets?
    Yes, especially in Asia-Pacific regions where cost sensitivity favors generic anti-inflammatories.

  4. What are the main barriers to BENSULFOID’s growth?
    Market dominance by existing drugs, patent expiration leading to generic competition, and regulatory hurdles.

  5. What strategies could improve BENSULFOID’s financial trajectory?
    Market expansion, formulation innovation, strategic licensing, and targeted marketing in emerging regions.


References

[1] Global Market Insights. (2022). Pain management drugs market size and forecast.
[2] IQVIA. (2022). Global pharmaceutical market data.
[3] World Health Organization. (2021). Regulations for anti-inflammatory drugs.
[4] Statista. (2022). Market share of NSAIDs in global markets.
[5] Evaluating Licensing Strategies. (2023). Industry reports on generic drug markets.

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