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Last Updated: April 12, 2025

CELESTONE SOLUSPAN Drug Patent Profile


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

Celestone Soluspan is a drug marketed by Organon and is included in one NDA.

The generic ingredient in CELESTONE SOLUSPAN is betamethasone acetate; betamethasone sodium phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betamethasone acetate; betamethasone sodium phosphate profile page.

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Summary for CELESTONE SOLUSPAN
Drug patent expirations by year for CELESTONE SOLUSPAN
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Recent Clinical Trials for CELESTONE SOLUSPAN

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SponsorPhase
ROC FoundationPhase 4
Loma Linda UniversityEarly Phase 1
University of KentuckyEarly Phase 1

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Pharmacology for CELESTONE SOLUSPAN

US Patents and Regulatory Information for CELESTONE SOLUSPAN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Organon CELESTONE SOLUSPAN betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 014602-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Expired US Patents for CELESTONE SOLUSPAN

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Organon CELESTONE SOLUSPAN betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 014602-001 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for CELESTONE SOLUSPAN

Introduction

CELESTONE SOLUSPAN, a brand of betamethasone sodium phosphate and betamethasone acetate injectable suspension, is a versatile corticosteroid used in various medical conditions. This article delves into the market dynamics and financial trajectory of CELESTONE SOLUSPAN, providing insights into its current market position, future projections, and the financial performance of its associated companies.

Market Overview

The betamethasone sodium phosphate market, which includes CELESTONE SOLUSPAN, has experienced significant growth in recent years. This market is segmented by type (injection, powder injection, drops) and application (intramuscular injection, intravenous injection), with geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Market Growth and Projections

The betamethasone sodium phosphate market is anticipated to continue its upward trend from 2023 to 2031. Recent years have seen swift and substantial growth, and forecasts indicate sustained significant expansion during the forecast period. This positive momentum is driven by increasing demand for corticosteroids in treating various allergic and inflammatory conditions[1].

Key Applications and Indications

CELESTONE SOLUSPAN is indicated for a wide range of conditions, including allergic states, respiratory diseases, rheumatic disorders, and dermatological conditions. Its use in intramuscular, intra-articular, and intralesional administrations makes it a versatile treatment option for acute and chronic conditions[4].

Market Drivers

Several factors drive the growth of the betamethasone sodium phosphate market:

  • Increasing Prevalence of Allergic and Inflammatory Conditions: The rising incidence of asthma, atopic dermatitis, and other allergic conditions contributes to the demand for corticosteroids like CELESTONE SOLUSPAN.
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to medical treatments in developing regions also boost market growth.
  • Diverse Applications: The multiple indications for CELESTONE SOLUSPAN make it a valuable asset in various medical specialties[1].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

  • Side Effects and Contraindications: Corticosteroids like CELESTONE SOLUSPAN can have significant side effects, such as elevated blood pressure, salt and water retention, and increased excretion of potassium. These factors can limit their use in certain patient populations[4].
  • Regulatory Challenges: Strict regulatory environments and the need for continuous compliance can pose challenges for manufacturers.

Financial Performance of Associated Companies

Organon, one of the companies associated with the production and distribution of corticosteroids, has reported mixed financial results in recent quarters. For the third quarter of 2024, Organon reported revenues of $1,582 million, a slight increase from $1,519 million in the third quarter of 2023. The gross profit was $923 million, with a non-GAAP adjusted gross profit of $976 million. Net income for the third quarter of 2024 was $359 million, significantly higher than the $58 million reported in the third quarter of 2023[2].

Revenue and Profit Margins

Organon's revenue growth is steady, but the company faces challenges such as unfavorable product mix and pricing, which affected the gross margin in the third quarter of 2024. The gross margin was 58.3% as-reported and 61.7% on a non-GAAP adjusted basis, slightly lower than the previous year[2].

Research and Development

Investments in research and development are crucial for maintaining market position. Organon spent $111 million on research and development in the third quarter of 2024, which is lower than the $137 million spent in the third quarter of 2023. This reduction could impact future product pipelines and market competitiveness[2].

Competitive Landscape

The market for betamethasone sodium phosphate is competitive, with several key players:

  • Ikon Remedies
  • AdvaCare Pharma
  • Zoic Pharma
  • Celestone Soluspan (Merck & Co., Inc., now part of Organon)
  • B-SOL
  • Malik Lifesciences Pvt. Ltd.
  • Chengdu Tiantai Mount Pharmaceutical
  • Suicheng Pharmaceutical

These companies compete based on product quality, pricing, and market reach[1].

Regional Market Analysis

The betamethasone sodium phosphate market is geographically diverse, with significant growth anticipated in regions such as Asia-Pacific due to increasing healthcare expenditure and improving healthcare infrastructure. North America and Europe also remain key markets due to high demand for corticosteroids in treating various medical conditions[1].

Conclusion

The market for CELESTONE SOLUSPAN and other betamethasone sodium phosphate products is poised for significant growth driven by increasing demand for corticosteroids, advancements in healthcare, and diverse applications. However, the market faces restraints such as side effects and regulatory challenges. Financially, associated companies like Organon report steady revenue growth but face challenges related to product mix and pricing.

Key Takeaways

  • Market Growth: The betamethasone sodium phosphate market is expected to grow significantly from 2023 to 2031.
  • Diverse Applications: CELESTONE SOLUSPAN is used in various medical conditions, making it a versatile treatment option.
  • Financial Performance: Associated companies report steady revenue growth but face challenges related to product mix and pricing.
  • Competitive Landscape: The market is competitive with several key players competing based on product quality, pricing, and market reach.
  • Regional Analysis: Asia-Pacific, North America, and Europe are key regions driving market growth.

FAQs

What are the primary indications for CELESTONE SOLUSPAN?

CELESTONE SOLUSPAN is indicated for allergic states, respiratory diseases, rheumatic disorders, and dermatological conditions, among others[4].

Which companies are key players in the betamethasone sodium phosphate market?

Key players include Ikon Remedies, AdvaCare Pharma, Zoic Pharma, Celestone Soluspan (Merck & Co., Inc., now part of Organon), B-SOL, Malik Lifesciences Pvt. Ltd., Chengdu Tiantai Mount Pharmaceutical, and Suicheng Pharmaceutical[1].

What are the market drivers for the betamethasone sodium phosphate market?

Market drivers include the increasing prevalence of allergic and inflammatory conditions, advancements in healthcare, and the diverse applications of betamethasone sodium phosphate[1].

What are the potential side effects of CELESTONE SOLUSPAN?

Potential side effects include elevated blood pressure, salt and water retention, increased excretion of potassium, and other systemic effects associated with corticosteroid use[4].

How has Organon's financial performance been in recent quarters?

Organon reported revenues of $1,582 million in the third quarter of 2024, with a net income of $359 million. However, the company faces challenges related to product mix and pricing[2].

Sources

  1. Market Research Intellect: Global Betamethasone Sodium Phosphate Market Size, Scope And Forecast 2023-2031.
  2. Organon: Organon Reports Results for the Third Quarter Ended September 30, 2024.
  3. UHCProvider: Omnibus Codes (for Mississippi Only) – Community Plan Medical.
  4. FDA: CELESTONE® SOLUSPAN® brand of betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP.
  5. Organon: Organon Reports Results for the First Quarter Ended March 31, 2023.

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