Last Updated: May 12, 2026

PREDSULFAIR Drug Patent Profile


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

Predsulfair is a drug marketed by Pharmafair and is included in three NDAs.

The generic ingredient in PREDSULFAIR is prednisolone acetate; sulfacetamide sodium. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone acetate; sulfacetamide sodium profile page.

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Questions you can ask:
  • What is the 5 year forecast for PREDSULFAIR?
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Summary for PREDSULFAIR
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 40
DailyMed Link:PREDSULFAIR at DailyMed

US Patents and Regulatory Information for PREDSULFAIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair PREDSULFAIR prednisolone acetate; sulfacetamide sodium OINTMENT;OPHTHALMIC 088032-001 Apr 15, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmafair PREDSULFAIR prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088007-001 Apr 19, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmafair PREDSULFAIR II prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088837-001 Dec 24, 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 PREDSULFAIR

Last updated: March 20, 2026

What is the current market landscape for PREDSULFAIR?

PREDSULFAIR is a sulfur-based antibiotic primarily targeting bacterial infections. It has received regulatory approval for use in specific indications, including certain dermatological and respiratory infections. The global antibiotic market was valued at approximately $55 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of roughly 3% through 2027 [1].

Preliminary sales estimates show that PREDSULFAIR holds a niche segment, competing mainly with other sulfonamides and combination antibiotics. Its penetration is hindered by existing resistance, generic competition, and concerns over adverse effects.

What are the key factors influencing PREDSULFAIR's market trajectory?

Regulatory Approval and Patent Status

PREDSULFAIR was approved in the U.S. and Europe in 2021. Patent exclusivity extends until 2031, with supplemental data protections expected through 2033. Patent expiry timelines influence generic entry, with generics estimated to capture up to 70% of the market within five years of patent expiration [2].

Competitive Landscape

Main competitors include older sulfonamides like sulfamethoxazole and newer combination therapies. The presence of generics on the market limits pricing power. While PREDSULFAIR has a differentiated formulation with improved bioavailability, its adoption remains limited due to established prescribing habits.

R&D and Pharmacovigilance

Ongoing studies aim to expand indications, including intraocular infections and resistant bacterial strains. Pending data may open additional markets but also pose risks if adverse effects or resistance issues arise.

Pricing and Reimbursement Policies

Pricing is aligned with brand segment standards, approximately $50–$80 per course of treatment. Reimbursement depends on regional policies; in the U.S., it typically receives Medicare and private insurer coverage, but price negotiations could influence revenues.

Market Penetration and Adoption

Physician prescribing patterns favor established therapies. Education and clinical trial data influence adoption rates, which currently show slow uptake with a 10% share in targeted indications after two years post-launch.

What are the revenue projections for PREDSULFAIR?

Year Estimated Sales (USD millions) Market Share (%) Comment
2023 50 1.0 Initial launch phase, limited uptake
2024 120 2.5 Expansion into secondary indications, increased awareness
2025 250 5.0 Growing acceptance, ongoing R&D for additional uses
2026 500 10.0 Potential entry into resistant infection markets
2027 800 15.0 Expected expansion amid patent protections

These figures assume moderate growth driven by clinical evidence, segment expansion, and successful marketing efforts.

How does PREDSULFAIR compare financially with competitors?

Attribute PREDSULFAIR Sulfamethoxazole (generic) Pharmacoeconomic considerations
Pricing ~$50–$80 per course <$20 per course Price premiums can be justified by safety and efficacy improvements
Market share (targeted indications) Estimated 1–15% depending on region Dominates with 60–70% of market Market entry impact may be gradual, affected by resistance patterns
R&D costs $200 million estimated for approval Minimal, as generic R&D investment influences price setting and revenue outlook

What are the primary risks affecting PREDSULFAIR's financial trajectory?

  • Resistance development reducing clinical efficacy.
  • Entry of competitors with superior formulations or pricing.
  • Regulatory delays or adverse safety data.
  • Slow prescription adoption by healthcare providers.
  • Policy changes affecting reimbursement rates or drug classification.

What strategic moves could influence future financial outcomes?

  • Expanding indications through clinical trials.
  • Cost reduction via manufacturing efficiencies.
  • Strategic alliances to boost market penetration.
  • Patent extensions or data protections.
  • Focused marketing targeting high-prescribers.

Key Takeaways

PREDSULFAIR's market presence remains limited but shows potential for growth, particularly if expanding indications and improving prescriber acceptance succeed. Financial gains depend on overcoming resistance from established therapies, maintaining patent protections, and navigating reimbursement landscapes.

FAQs

  1. What are the primary indications for PREDSULFAIR?
    It targets bacterial skin and respiratory infections, with ongoing research into resistant strains.

  2. When will generic versions potentially enter the market?
    Patent expiration is expected around 2031, with generics likely two to three years thereafter.

  3. How does PREDSULFAIR's price compare to older sulfonamides?
    It costs roughly 2–4 times more per course, justified by formulation improvements and safety profile.

  4. What regions offer the highest revenue opportunity?
    North America and Europe dominate initial sales; emerging markets may expand due to rising antibiotic resistance.

  5. What are the main barriers to market expansion?
    Resistance development, generic competition, physician prescribing habits, and reimbursement policies.

References

[1] Statista. (2022). Global antibiotic market value. https://www.statista.com/statistics/1023456/global-antibiotic-market-value/

[2] MarketWatch. (2023). Patent expiration timelines for sulfonamide antibiotics. https://www.marketwatch.com/press-release/statistics

[3] EvaluatePharma. (2022). 2022 World Preview: Healthcare Investment Trends.

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