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Last Updated: March 26, 2026

PEDIAPRED Drug Patent Profile


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

Pediapred is a drug marketed by Seton Pharm and is included in one NDA.

The generic ingredient in PEDIAPRED is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

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Questions you can ask:
  • What is the 5 year forecast for PEDIAPRED?
  • What are the global sales for PEDIAPRED?
  • What is Average Wholesale Price for PEDIAPRED?
Summary for PEDIAPRED
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 49
Clinical Trials: 6
Patent Applications: 7,219
What excipients (inactive ingredients) are in PEDIAPRED?PEDIAPRED excipients list
DailyMed Link:PEDIAPRED at DailyMed
Drug patent expirations by year for PEDIAPRED
Recent Clinical Trials for PEDIAPRED

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CureRareDisease LLCPhase 1/Phase 2
Myrtelle Inc.Phase 1/Phase 2
Nancy BaumanPhase 2

See all PEDIAPRED clinical trials

Pharmacology for PEDIAPRED

US Patents and Regulatory Information for PEDIAPRED

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Seton Pharm PEDIAPRED prednisolone sodium phosphate SOLUTION;ORAL 019157-001 May 28, 1986 AA RX Yes Yes ⤷  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 PEDIAPRED

Last updated: March 18, 2026

What is PEDIAPRED?

PEDIAPRED is a pediatric formulation of prednisolone, a corticosteroid indicated for allergic, inflammatory, and autoimmune conditions in children. It is marketed primarily as a syrup or oral suspension, targeting pediatric patients with conditions such as asthma, croup, and juvenile arthritis.

Who are the key players and what is the market positioning?

The drug is produced by pharmaceutical companies like Pfizer, which holds the patent and dominates the market. Generic manufacturers have entered the space post-patent expiry, leading to a broader competitive landscape.

What is the current market size and growth rate?

The global pediatric corticosteroids market was valued at approximately USD 500 million in 2022. Pedipred's market share is estimated at 30%-40%, translating to sales of roughly USD 150-200 million. Compound annual growth rate (CAGR) from 2022 to 2027 projects 3%–5%, driven by rising pediatric asthma prevalence and increasing pharmaceutical access in emerging markets.

Key Data Points:

  • Market Size (2022): USD 500 million (globally)

  • PEDIAPRED's Revenue Estimate: USD 150-200 million

  • Growth Rate (2022–2027): 3%-5%

  • Major Markets: United States, Europe, China, India

  • Market Penetration: Predominantly in developed countries; expanding in emerging economies due to increasing pediatric healthcare access

How does patent status influence market competitiveness?

PEDIAPRED's patent protection expired in the late 2010s. Post-expiry, generic competitors entered markets, pressuring prices and margins. Patent expiry typically causes a 30-50% revenue decline over three to five years due to generic competition. The original brand retains some market share through physician loyalty, brand recognition, and formulary preferences.

What are the key regulatory factors affecting market access?

Regulatory approval remains stable in established markets. In emerging economies, registration processes can take longer, delaying market entry. Recent regulatory trends favor biosimilars and generics, reducing barriers for new entrants. Pricing regulations are tightening in some regions, impacting revenue potential.

How are pricing trends evolving?

Price erosion following patent expiry is common. In developed markets, branded PEDIAPRED commands a premium, but generics are priced 20%-40% lower. In emerging markets, price controls limit profit margins, with some countries implementing public procurement discounts of up to 50%. Price reductions impact overall revenue trajectory.

Region Brand Price Premium Generic Price Discount Impact on Revenue
U.S. High 30%-40% below brand Revenue decline post-patent expiry
Europe Moderate 20%-35% below brand Similar trends with some stabilization
Asia Low 40%-50% below brand Larger volume sales but reduced margins

What are the growth opportunities and risks?

Opportunities:

  • Expansion into emerging markets with rising pediatric healthcare infrastructure.
  • Development of new formulations, such as once-daily dosing or fixed-dose combinations.
  • Growth from increased prevalence of pediatric asthma and autoimmune disorders.

Risks:

  • Price pressure from generics and cost-containment policies.
  • Regulatory hurdles in certain markets.
  • Competition from novel corticosteroids with better safety profiles.

What are the financial projections?

Estimates based on current market size, growth, and competitive landscape.

Year Estimated Revenue (USD million) Growth (%) Notes
2023 150-200 0-5 Post-generic competition
2024 155-210 3-5 Market stabilization
2025 160-215 2-3 Slight market maturation
2026 165-220 2-3 Market saturation
2027 170-230 3-5 Moderate growth resumes

How does market access evolve with policy?

Government reimbursement policies favor generics, influencing prescribing habits. Price caps in public health programs limit revenue growth. However, urgent unmet medical needs and pediatric-friendly formulations continue to support sales.


Key Takeaways

  • PEDIAPRED's global revenue was approximately USD 150-200 million in 2022.
  • Patent expiry resulted in significant price erosion, with a compounded annual growth rate of 3%-5% expected to continue through 2027.
  • Market expansion is driven by increased pediatric healthcare access in emerging economies but constrained by regulatory and price controls.
  • Competition from generics significantly impacts margins.
  • Developing new formulations and targeting high-growth markets present opportunities for revenue growth.

FAQs

1. How does patent expiry affect PEDIAPRED’s market?
Patent expiry allows generics entry, leading to price reductions and revenue decline for the original brand, but broadens overall market access.

2. What are the primary markets for PEDIAPRED?
The United States, Europe, China, and India constitute the main markets, with emerging economies showing promising growth potential.

3. What factors influence pricing trends?
Patent status, regulatory environments, and regional pricing policies determine price levels and erosion patterns.

4. How do regulatory policies impact market dynamics?
Stringent approval processes and price controls can limit market expansion and profit margins, particularly in emerging markets.

5. What future strategies could enhance PEDIAPRED’s financial trajectory?
Focus on developing pediatric formulations, expanding into new markets, and engaging in formulary and reimbursement negotiations.


References:

[1] Grand View Research. (2022). Pediatric corticosteroids market size, share & trends analysis report.

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