CYCLOCORT Drug Patent Profile

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

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. Four 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:	1
Patent Applications:	8,272
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	4,158,055
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	Approved Prior to Jan 1, 1982	4,158,055

International Patents for CYCLOCORT

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1442925
Hungary	172213	SPOSOB POLUCHENIJA 16AL'FA, 17AL'FA-CIKLOPENTILIDENDIOKSI-9AL'FA-FTOR-11BETA, 21-DIGIDROKSI-PREGNA-1,4-DIEN-3,20-DION-21-ACETATA I LECHEBNYKH PREPARATOV SODERZHAHHIKH EHTO SOEDINENIE KAK AKTIVNYJ KOMPONENT (PROCESS FOR PREPARING 16ALPHA,17ALPHA-CYCLOPENTYLIDENE-DIOXY-9ALPHA-FLUORO-11BETA,21-DIHYDROXY-PREGNA-1,4-DIENE-3,20-DIONE-21-ACETATE AND PHARMACEUTICAL PREPARATIONS CONTAINING THIS COMPOUND AS ACTIVE MATERIAL)
Philippines	12415	16A,17-CYCLOPENTYLIDENEDIOXY-9A-FLUORO-11,21-DIHYDROXY-1,4-PREGNADIENE-3,20-DIONE 21-ACETATE,ANTI-INFLAMMATORY COMPOSITION AND METHOD OF USE THEREOF
Israel	45200
Japan	S557407

Market Dynamics and Financial Trajectory for CYCLOCORT

Last updated: February 27, 2026

What is CYCLOCORT?

CYCLOCORT is a topical corticosteroid primarily used for inflammation, allergic reactions, and skin conditions such as eczema and dermatitis. It is marketed in various formulations, including creams and ointments. The drug competes in the dermatology segment against brands like Hydrocortisone, Betamethasone, and Clobetasol.

Market Size and Growth Drivers

The global dermatology market, which includes corticosteroids like CYCLOCORT, was valued at approximately USD 35 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 7% through 2030, driven by increasing prevalence of skin disorders, rising awareness, and dermatological treatment advancements.

Within this segment, topical corticosteroids account for nearly 25% of market revenue, with growth fueled by rising cases of eczema, psoriasis, and allergic skin conditions globally.

Geographic Market Distribution

Region	Market Share (2022)	CAGR (2023-2030)	Key Drivers
North America	40%	6%	High prevalence of skin conditions, advanced healthcare infrastructure
Europe	25%	7%	Aging population, increased dermatology clinics
Asia-Pacific	20%	9%	Large population base, rising awareness
Latin America & Others	15%	7%	Growing skincare industry, increasing prescription rates

Competitive Landscape

Major competitors in the corticosteroid market include:

• Hydrocortisone (over-the-counter formulations)
• Betamethasone (prescription, high potency)
• Clobetasol (ultra-high potency)

CYCLOCORT is positioned in the mid-potency corticosteroid segment, vying for prescription-driven demand.

Leading pharmaceutical companies manufacturing corticosteroids include GlaxoSmithKline, Novartis, and Teva. Regional manufacturers also operate in emerging markets, where generic corticosteroids maintain a significant share.

Regulatory and Patent Landscape

• Regulatory approvals vary by region; for example, in the US, CYCLOCORT is classified as a prescription drug regulated by the FDA.
• Patent expirations for corticosteroid formulations generally occur around 2023-2025, allowing generics to enter markets.
• Patent extensions or formulations with novel delivery methods could influence pricing and market share.

Pricing and Reimbursement Policies

Pricing varies globally:

• United States: CYCLOCORT formulary coverage is primarily through private insurers, with copays ranging from USD 10-30 per month for branded versions.
• Europe: Reimbursement policies favor cost-effective generics; branded drugs see reimbursement rates of 60-80%.
• Emerging Markets: Lower purchasing power influences lower pricing; government procurement can negotiate discounts.

Financial Trajectory and Revenue Projections

Assuming a mid-potency corticosteroid market growth and CYCLOCORT's market share:

Year	Estimated Market Size (USD billion)	CYCLOCORT Revenue (USD million)	Assumed Market Share
2022	8.75	125	1.4%
2025	11.2	190	1.7%
2030	15.6	370	2.4%

The growth factors include increased prescription volumes due to rising skin diseases and expanded geographic penetration. Price erosion from generics may suppress per-unit revenue but can be offset by volume growth.

Key Market Risks

• Patent expiry: Leads to generic competition, eroding branded revenues.
• Regulatory delays: New formulations or delivery systems face approval hurdles.
• Pricing pressures: Especially in price-sensitive markets, could impact margins.
• Market saturation: Limited growth in mature markets may restrict revenue expansion.

Strategic Opportunities

• Formulation innovation: Developing liposomal or controlled-release versions can provide differentiation.
• Regional expansion: Priority to markets with rising dermatological disease prevalence, such as India and China.
• Partnerships: Licensing deals with regional manufacturers to accelerate distribution.

Conclusion

CYCLOCORT operates within a competitive, mature segment of the dermatology market. The compound's revenue growth hinges on geographic expansion and formulation improvements. Price competition and patent expiration pose risks but can be mitigated through strategic diversification. The global dermatology sector presents sustained potential driven by demographic trends and increased skin health awareness.

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Key Takeaways

• The global corticosteroid market is expected to reach USD 15.6 billion by 2030 at a CAGR of 7%.
• CYCLOCORT's market share is projected to grow modestly from 1.4% in 2022 to 2.4% in 2030.
• Patent expirations and generics may impact revenues post-2023.
• Expansion into emerging markets offers significant growth prospects.
• Innovation in formulation and delivery can maintain competitive advantage.

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FAQs

1. What factors influence CYCLOCORT's market growth?
Market growth depends on rising skin disease prevalence, geographic expansion, formulation improvements, and regulatory approvals.

2. How does patent expiration affect CYCLOCORT?
Patent expiry opens the market to generics, increasing competition and potentially lowering prices and revenues for branded formulations.

3. Which regions offer the greatest growth opportunities for CYCLOCORT?
Emerging markets in Asia-Pacific and Latin America present the strongest growth prospects due to increasing skin disorder cases and lower market saturation.

4. What are the main risks facing CYCLOCORT's market position?
Patent expirations, regulatory delays, pricing pressures, and saturation in mature markets threaten revenue streams.

5. How can CYCLOCORT sustain long-term growth?
Through formulation innovations, geographical expansion, and strategic partnerships, CYCLOCORT can adapt to market changes and maintain relevance.

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References

1. MarketsandMarkets. (2022). Dermatology market by product, region, and application.
2. IQVIA. (2022). Pharmaceuticals and Oncology Market Reports.
3. FDA. (2022). Regulatory Status of Topical Corticosteroids.
4. European Medicines Agency. (2022). Marketing authorizations for dermatological drugs.
5. Statista. (2022). Global skin disease prevalence data.