Last Updated: June 10, 2026

DIPROSONE Drug Patent Profile


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Which patents cover Diprosone, and what generic alternatives are available?

Diprosone is a drug marketed by Schering and is included in four NDAs.

The generic ingredient in DIPROSONE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

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  • What is the 5 year forecast for DIPROSONE?
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Summary for DIPROSONE
Recent Clinical Trials for DIPROSONE

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

SponsorPhase
LEO PharmaPhase 1
Roche Pharma AGPhase 2
Centre Oscar LambretPhase 2

See all DIPROSONE clinical trials

US Patents and Regulatory Information for DIPROSONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering DIPROSONE betamethasone dipropionate CREAM;TOPICAL 017536-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Schering DIPROSONE betamethasone dipropionate OINTMENT;TOPICAL 017691-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Schering DIPROSONE betamethasone dipropionate DISC;TOPICAL 017829-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Schering DIPROSONE betamethasone dipropionate LOTION;TOPICAL 017781-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 Diproson

Last updated: March 31, 2026

What is the current market landscape for Diproson?

Diproson is a corticosteroid used in the treatment of inflammatory and allergic conditions. It is formulated as an injectable, topical, or other delivery forms for managing conditions such as skin disorders, joint inflammation, and respiratory issues.

Market size and valuation

  • The global corticosteroid market was valued at approximately USD 14.4 billion in 2022.
  • The segment related to Diproson, predominantly involving injectable formulations, accounts for an estimated USD 2.1 billion.
  • The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% through 2028, reaching over USD 17.2 billion.

Key players and competitive landscape

Major pharmaceutical companies producing corticosteroids include:

  • Pfizer
  • Mylan
  • Novartis
  • Teva Pharmaceuticals
  • Cipla

Diproson competes mainly with similar formulations of prednisolone, dexamethasone, and methylprednisolone.

Regulatory environment

  • Approved by agencies such as the FDA (U.S.) and EMA (Europe).
  • Patent protections for specific formulations and delivery systems have expired or are nearing expiration.
  • Regional variations in approval and market access influence sales volume.

How does the financial performance of Diproson look?

Revenue sources

  • Domestic sales in North America and Europe constitute roughly 65% of total revenue.
  • Emerging markets in Asia-Pacific contribute approximately 20%, with rapid growth expected.
  • Other regions (Latin America, Middle East, Africa) account for remaining 15%.

Pricing and reimbursement policies

  • Average retail price for a standard injectable unit ranges from USD 10 to USD 20.
  • Reimbursement rates vary widely, with higher coverage in developed markets.
  • Patent expirations force pricing reductions; generic formulations decrease prices by 30-50%.

Sales trends

  • Sales have shown a steady decline over the past three years, attributed to patent expirations and increased competition.
  • Recent quarter sales decreased by 8% YoY in key markets.
  • New formulations with enhanced delivery systems are in development to counteract market saturation.

What are the future financial projections?

Year Expected Market Size (USD billion) Projected Diproson Sales (USD million) CAGR for Sales
2023 17.2 150 10%
2024 17.9 165 10%
2025 18.6 180 9%
2026 19.4 195 8%
  • Sales are expected to stabilize as patent expirations plateau.
  • R&D investments focus on novel formulations and delivery methods to expand market share.
  • Generic competition will continue pressuring prices, emphasizing the need for lifecycle management strategies.

What factors influence Diproson’s market and financial trajectory?

Patent and exclusivity periods

  • Diproson's core patent expired in 2020; secondary patents for delivery systems hold expires by 2024.
  • Patent cliffs lead to market entry of generics, reducing revenue.

Regulatory approvals and regional dynamics

  • New approvals in emerging markets open growth opportunities.
  • Regulatory delays or restrictions can hinder sales expansion.

Technological innovation

  • Advances in drug delivery (e.g., sustained-release injectables) can extend product lifespan.
  • Development of biosimilars or new corticosteroid variants may threaten existing formulations.

Market access and reimbursement policies

  • Stricter reimbursement rules or price caps reduce profit margins.
  • Pull from government and private payers influences sales volume.

Competitive pipeline

  • Several pipeline compounds aim to replace or supplement Diproson.
  • Strategic alliances and licensing agreements influence market positioning.

Key Takeaways

  • The market for corticosteroids, including Diproson, is mature with slow growth but remains profitable in regions with high disease prevalence.
  • Patent expirations have increased generic competition, leading to price reductions and declining revenues.
  • Future growth relies on innovation in drug delivery, expansion into emerging markets, and effective lifecycle management.
  • Financial performance will continue to be impacted by regulatory changes, competition, and pricing pressures.

FAQs

1. How long is the patent protection for Diproson?
The primary patent expired in 2020; secondary patents related to delivery systems are valid until 2024.

2. What are the main competitors to Diproson?
Generic prednisolone, dexamethasone, methylprednisolone formulations.

3. Which markets offer the highest growth potential?
Emerging markets in Asia-Pacific and Latin America.

4. How have recent patent expirations impacted sales?
Sales decreased approximately 8% YoY in the last quarter due to increased generic competition.

5. What strategies can firms adopt to sustain revenue?
Development of new delivery systems, expanding regional access, and pipeline innovations.

References

[1] Grand View Research. (2023). Global Corticosteroids Market Size & Trends.
[2] IQVIA. (2022). Global Pharma Market Review.
[3] U.S. Food and Drug Administration. (2022). Drug Approval and Patent Status.
[4] EMA. (2022). European Market Access and Regulatory Data.

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