CYCLOCORT Drug Patent Profile

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

Cyclocort is a drug marketed by Astellas and is included in three NDAs.

The generic ingredient in CYCLOCORT is amcinonide. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amcinonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cyclocort

A generic version of CYCLOCORT was approved as amcinonide by TARO PHARM INDS on May 31^st, 2002.

Summary for CYCLOCORT

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	53
Patent Applications:	5,640
DailyMed Link:	CYCLOCORT at DailyMed

US Patents and Regulatory Information for CYCLOCORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astellas	CYCLOCORT	amcinonide	LOTION;TOPICAL	019729-001	Jun 13, 1988		DISCN	Yes	No

Expired US Patents for CYCLOCORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-002	Approved Prior to Jan 1, 1982
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	Approved Prior to Jan 1, 1982

International Patents for CYCLOCORT

See the table below for patents covering CYCLOCORT around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	45200
Cyprus	946	NOVEL TRIAMCINOLONE DERIVATIVE
Netherlands	184899
Ireland	39738	NOVEL TRIAMCINOLONE DERIVATIVE

CYCLOCORT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CYCLOCORT

Introduction

CYCLOCORT, a high-potency topical corticosteroid containing amcinonide, is widely used for the relief of inflammatory and pruritic manifestations of various dermatoses. To understand its market dynamics and financial trajectory, it is essential to delve into its usage, market positioning, competition, and economic factors.

Uses and Indications

CYCLOCORT is indicated for the treatment of a variety of skin conditions, including eczema, dermatitis, allergies, and rashes. It is available in several formulations such as ointment, cream, and lotion, each with specific uses and application durations[1][4][5].

Market Positioning

CYCLOCORT is a well-established brand in the dermatological market, particularly in the segment of topical corticosteroids. Its high potency and efficacy in treating inflammatory skin conditions have secured its position as a preferred treatment option for both healthcare providers and patients.

Brand and Generic Competition

The market for CYCLOCORT includes both brand-name and generic versions. The original brand, Cyclocort, is marketed by companies like GlaxoSmithKline, while generic versions are available from various manufacturers such as DPT Laboratories and Taro Pharmaceuticals. This competition can impact pricing and market share[4].

Pricing and Cost Considerations

The pricing of CYCLOCORT and its generic counterparts varies based on the formulation, quantity, and region. For instance, the cost of amcinonide 0.1% cream or ointment can range from approximately $20 to $84 for different tube sizes. These prices are generally competitive with other topical corticosteroids in the market[4].

Economic Factors

Cost Savings and Importation Programs

In some regions, the cost of CYCLOCORT and similar medications can be reduced through importation programs. For example, programs like I-SaveRx and MinnesotaRxConnect have shown that retail drug prices through importation can be significantly lower than those through domestic mail-order pharmacies. However, these programs also come with their own set of regulatory and logistical challenges[2].

Healthcare Coverage and Reimbursement

The financial trajectory of CYCLOCORT is also influenced by healthcare coverage and reimbursement policies. In many cases, the cost savings to individuals and states depend on the level of discount offered through insurance programs and the specific medications covered. For state employees and retirees, the co-payments for such medications can be relatively low, affecting the overall financial impact of the drug on the healthcare system[2].

Regulatory Environment

Safety and Efficacy

The regulatory environment plays a crucial role in the market dynamics of CYCLOCORT. The drug must comply with strict safety and efficacy standards set by regulatory bodies like the FDA. This includes monitoring for potential side effects such as skin atrophy, HPA axis suppression, and increased risk of infections. Compliance with these regulations ensures the drug's continued presence in the market[1][5].

Special Populations

The use of CYCLOCORT in special populations, such as geriatric patients and those with renal or hepatic impairment, requires careful consideration. The drug should be used with caution in these groups due to the increased risk of adverse effects, which can impact its market acceptance and usage[1].

Market Trends and Future Outlook

Biotechnology and Pharmaceutical Advancements

The pharmaceutical industry is continuously evolving, with advancements in biotechnology and drug delivery systems. While CYCLOCORT is a well-established product, future trends may include the development of new formulations or delivery methods that could potentially disrupt the market. However, the current metrics for success in drug development suggest that improvements in drug delivery systems are crucial for maintaining market competitiveness[3].

Generic Market Growth

The growth of the generic market is another significant trend. As patents expire, more generic versions of CYCLOCORT are likely to enter the market, which could lead to increased competition and potentially lower prices. This trend is expected to continue, influencing the financial trajectory of the drug[4].

Financial Performance

Revenue and Sales

The financial performance of CYCLOCORT is influenced by its sales and revenue. While specific financial data for CYCLOCORT is not readily available, the overall market for topical corticosteroids is substantial. The revenue generated from CYCLOCORT and its generic versions contributes significantly to the pharmaceutical companies' bottom line.

Cost of Production and Distribution

The cost of production, distribution, and marketing also plays a critical role in the financial performance of CYCLOCORT. Companies must balance these costs with the pricing strategy to ensure profitability. Factors such as raw material costs, manufacturing processes, and regulatory compliance can affect the overall cost structure[3].

Key Takeaways

• Market Positioning: CYCLOCORT is a high-potency topical corticosteroid with a strong market position due to its efficacy in treating various dermatoses.
• Pricing and Competition: The drug faces competition from both brand-name and generic versions, influencing its pricing and market share.
• Economic Factors: Cost savings through importation programs and healthcare coverage policies impact the financial trajectory of CYCLOCORT.
• Regulatory Environment: Compliance with safety and efficacy standards is crucial for the drug's continued market presence.
• Market Trends: Advancements in biotechnology and the growth of the generic market are key trends that could influence the future of CYCLOCORT.

FAQs

What is CYCLOCORT used for?

CYCLOCORT is used to treat inflammatory and pruritic manifestations of various dermatoses, including eczema, dermatitis, allergies, and rashes.

What are the potential side effects of CYCLOCORT?

Potential side effects include skin atrophy, HPA axis suppression, increased risk of infections, and systemic absorption leading to increased intraocular pressure, glaucoma, or cataracts if used near the eye[1][5].

Can CYCLOCORT be used in special populations?

CYCLOCORT should be used with caution in geriatric patients and those with renal or hepatic impairment due to the increased risk of adverse effects[1].

How does the pricing of CYCLOCORT compare to other topical corticosteroids?

The pricing of CYCLOCORT is competitive with other topical corticosteroids, with costs varying based on the formulation and quantity[4].

What impact do importation programs have on the cost of CYCLOCORT?

Importation programs can significantly reduce the cost of CYCLOCORT, offering savings of up to 50% compared to domestic prices[2].

Sources

1. RxList: Cyclocort Ointment (Amcinonide Topical): Side Effects, Uses...
2. CT.gov: Prescription Drug Reimportation in Connecticut
3. UV.mx: Pharmaceutical Manufacturing Handbook
4. DrugBank: Amcinonide: Uses, Interactions, Mechanism of Action
5. WebMD: Cyclocort Topical: Uses, Side Effects, Interactions, Pictures...