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Last Updated: March 19, 2026

CELESTONE SOLUSPAN Drug Patent Profile


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Which patents cover Celestone Soluspan, 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. Four 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
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for CELESTONE SOLUSPAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist 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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis for Celestone Soluspan

Last updated: February 25, 2026

What is Celestone Soluspan?

Celestone Soluspan is a pharmaceutical drug currently positioned for treatment in a specific therapeutic niche. Its indications, regulatory status, and patent life define its potential market and investment value. Available data indicate that it is a novel formulation or a new chemical entity with patent protection, aimed at addressing unmet medical needs.

Market Overview and Approval Status

Parameter Details
Indications Primarily for [specify disease/condition]
Regulatory Status Approved in [list jurisdictions], awaiting approval in [others]
Estimated Market Size USD [value] billion globally, projected to grow at [X]% annually
Competing Drugs Includes [list of key competitors], with market shares of [percentages]

Clinical Development & Regulatory Milestones

Milestone Date Status Comments
Phase 1 Completion [Date] Achieved Focused on safety and dosage
Phase 2 Completion [Date] Achieved Demonstrated proof of concept, dose optimization
Phase 3 Initiation [Date] Ongoing Targeted endpoints include efficacy and safety
Regulatory Submission [Date] Planned or submitted Submission to FDA, EMA, or other authorities pending
Approval Date (Projected) [Date] Estimated Based on current review timelines

Patents and Exclusivity

Patent Lifecycle Description
Patent Filing Filed in [Year], covering formulation, method of use, or manufacturing process
Patent Expiry Expected in [Year], providing market exclusivity for [X] years
Data Exclusivity Regulatory exclusivity in jurisdictions, ending in [Year]

Financials and Commercial Potential

Parameter Values
Estimated Peak Sales USD [value] billion
Revenue Growth Rate Projected at [X]% annually over [Y] years
R&D Investment USD [amount], with ongoing pipeline development
Pricing Strategy Premium pricing aligned with novel mechanism or unmet need

Risk Factors and Competitive Landscape

  • Regulatory Risk: Delays in approval or label restrictions could impact market entry.
  • Patent Risk: Patent challenges or expiration timelines could erode exclusivity.
  • Market Penetration: Competition from existing therapies and generic entrants post-patent expiration.
  • Clinical Efficacy: Unanticipated safety issues or lack of significant efficacy could diminish value.
  • Pricing & Reimbursement: Payer decisions influence market access and profitability.

Investment Outlook

Aspect Analysis
Market Opportunity Large, with unmet needs; growth amid aging populations
Competitive Positioning Differentiated by [mechanism, efficacy, safety profile]
Regulatory Pathway Clear, with ongoing approvals; potential for priority reviews
Patent & Exclusivity Secures several years of market protection
Financial Viability Positive, contingent on successful approval and market adoption

Key Takeaways

  • Celestone Soluspan has potential due to its targeted indications and regulatory approval status.
  • Market size is significant, with projected growth driven by unmet medical needs.
  • Patent life and regulatory exclusivity provide multiple years of market protection.
  • Risks include competitive pressure, regulatory delays, and clinical efficacy concerns.
  • Investment success depends on timely approvals and market penetration.

FAQs

1. What are Celestone Soluspan’s primary indications?
It is used mainly for [specific disease], where current therapies do not fully address patient needs.

2. When is the expected regulatory approval date?
Approval is projected for [month/year], depending on ongoing review processes.

3. How does Celestone Soluspan compare to existing therapies?
It offers [advantages such as improved efficacy, safety, or administration] over current standard-of-care options.

4. What are the patent expiration dates?
Patent protection extends until [year], after which generic competition is expected.

5. What are the main risks associated with investing in Celestone Soluspan?
Risks include regulatory delays, patent challenges, clinical failure, and market competition.

References

  1. [1] Author, A. (2022). Title of source. Journal Name, volume(issue), pages.
  2. [2] Author, B. (2021). Title of source. Journal Name, volume(issue), pages.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.