CELESTONE Drug Patent Profile

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

Celestone is a drug marketed by Schering, Merck Sharp Dohme, and Organon. and is included in five NDAs.

The generic ingredient in CELESTONE 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Celestone

A generic version of CELESTONE was approved as betamethasone acetate; betamethasone sodium phosphate by AM REGENT on July 31^st, 2009.

Summary for CELESTONE

US Patents:	0
Applicants:	3
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	21
Patent Applications:	4,372
Drug Prices:	Drug price information for CELESTONE
DailyMed Link:	CELESTONE at DailyMed

See drug prices for CELESTONE

Recent Clinical Trials for CELESTONE

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

Sponsor	Phase
CTM Biomedical	Phase 2
Indiana Hand to Shoulder Center	Phase 2
Population Health Research Institute	Phase 4

See all CELESTONE clinical trials

US Patents and Regulatory Information for CELESTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	CELESTONE	betamethasone	CREAM;TOPICAL	014762-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Schering	CELESTONE	betamethasone	TABLET;ORAL	012657-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Schering	CELESTONE	betamethasone sodium phosphate	INJECTABLE;INJECTION	017561-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Merck Sharp Dohme	CELESTONE	betamethasone	SYRUP;ORAL	014215-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon	CELESTONE SOLUSPAN	betamethasone acetate; betamethasone sodium phosphate	INJECTABLE;INJECTION	014602-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for CELESTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	CELESTONE	betamethasone	CREAM;TOPICAL	014762-001	Approved Prior to Jan 1, 1982
Schering	CELESTONE	betamethasone	TABLET;ORAL	012657-003	Approved Prior to Jan 1, 1982
Merck Sharp Dohme	CELESTONE	betamethasone	SYRUP;ORAL	014215-002	Approved Prior to Jan 1, 1982

CELESTONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Celestone

Introduction

Celestone, a brand name for the generic drug betamethasone, is a glucocorticoid used to treat a variety of medical conditions, including allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, respiratory diseases, and rheumatic disorders. Here, we will delve into the market dynamics and financial trajectory of Celestone, considering its current status, market trends, and financial implications.

Current Status of Celestone

The Celestone brand name has been discontinued in the U.S., although generic versions of betamethasone may still be available and approved by the FDA[1].

Market Trends in Pharmaceutical Expenditures

The pharmaceutical market is experiencing significant growth, driven by several factors including increased utilization, new drug approvals, and price changes. For 2024, overall prescription drug spending is expected to rise by 10.0% to 12.0%, with clinics and hospitals anticipating an 11.0% to 13.0% increase[3].

Impact of Generic Drugs

The discontinuation of the Celestone brand and the availability of generic betamethasone can influence market dynamics. Generic drugs often reduce costs for patients and healthcare systems, which can lead to increased utilization but may also impact the revenue of pharmaceutical companies.

Financial Trajectory of Pharmaceutical Companies

Companies involved in the production and distribution of glucocorticoids like betamethasone face various financial challenges and opportunities.

Revenue and Gross Margins

Pharmaceutical companies are experiencing fluctuations in gross margins due to factors such as product mix, inflationary costs, and increased promotional expenses. For instance, Organon & Co. reported a year-over-year decline in gross margins, partly due to product mix and inflationary cost pressures[2].

Operating Expenses and R&D

Companies are investing heavily in research and development (R&D) and promotional activities for new and existing products. This investment is crucial for future growth but can also lead to higher operating expenses. Organon & Co. noted an increase in R&D spend associated with recent acquisitions of clinical-stage assets[2].

Cash Flow and Financial Guidance

Despite short-term challenges, pharmaceutical companies are optimistic about their long-term financial performance. For example, Organon & Co. expects to generate over $1 billion in free cash flow before one-time items in 2023, consistent with their annual guidance[2].

Specific Financial Considerations for Celestone

Given that Celestone is no longer a branded product in the U.S., the financial impact is more nuanced.

Generic Competition

The availability of generic betamethasone reduces the potential for high revenue from this specific product. Generic competition typically leads to lower prices and reduced profit margins for the original manufacturer.

Market Share

The discontinuation of the Celestone brand means that any market share it once held would be redistributed among generic versions of betamethasone. This redistribution can affect the financial performance of companies that once relied on the branded product.

Regulatory and Policy Impacts

Regulatory changes and policy decisions can significantly influence the financial trajectory of pharmaceutical products.

New Drug Approvals and Patent Expirations

New drug approvals and patent expirations are key factors that can drive changes in pharmaceutical spending. For instance, the approval of new drugs in 2024 is expected to influence spending patterns, particularly in the areas of specialty, endocrine, and cancer drugs[3].

Public Policy and Healthcare Reforms

Public policy changes and healthcare reforms can impact the pricing, reimbursement, and overall market dynamics of pharmaceutical products. These changes can either boost or hinder the financial performance of companies involved in the production and distribution of drugs like betamethasone.

Conclusion

The market dynamics and financial trajectory for Celestone are shaped by its discontinuation as a branded product, the rise of generic competition, and broader trends in pharmaceutical expenditures.

Key Takeaways

• Discontinuation of Branded Product: The Celestone brand has been discontinued in the U.S., leading to a shift towards generic versions of betamethasone.
• Generic Competition: Generic betamethasone reduces prices and profit margins, impacting the financial performance of original manufacturers.
• Market Trends: Overall prescription drug spending is expected to rise, driven by increased utilization, new drug approvals, and price changes.
• Financial Performance: Pharmaceutical companies face challenges such as declining gross margins and increased operating expenses but remain optimistic about long-term financial performance.

FAQs

What is Celestone?

Celestone is a brand name for the generic drug betamethasone, a glucocorticoid used to treat various medical conditions.

Why has the Celestone brand been discontinued?

The Celestone brand has been discontinued in the U.S., although generic versions of betamethasone may still be available.

How does the discontinuation of Celestone affect its market dynamics?

The discontinuation leads to a shift towards generic versions, reducing prices and profit margins for the original manufacturer.

What are the key drivers of pharmaceutical expenditure growth in 2024?

Increased utilization, new drug approvals, and price changes are expected to drive growth in pharmaceutical expenditures in 2024.

How do regulatory changes impact the financial trajectory of pharmaceutical products?

Regulatory changes, such as new drug approvals and patent expirations, can significantly influence spending patterns and the financial performance of pharmaceutical companies.

Sources

1. Drugs.com: Celestone: Package Insert / Prescribing Information.
2. Organon & Co.: Q1 2023 Earnings Call Transcript.
3. PubMed: National trends in prescription drug expenditures and projections for 2024.
4. Health Canada: Details for: CELESTONE SOLUSPAN.