AMCINONIDE - Generic Drug Details

What are the generic drug sources for amcinonide and what is the scope of patent protection?

Amcinonide is the generic ingredient in two branded drugs marketed by Genus Lifesciences, Taro Pharm Inds, Astellas, Solubiomix, and Genus, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for amcinonide. Four suppliers are listed for this compound.

Summary for AMCINONIDE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	8
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	7,018
Drug Prices:	Drug price trends for AMCINONIDE
What excipients (inactive ingredients) are in AMCINONIDE?	AMCINONIDE excipients list
DailyMed Link:	AMCINONIDE at DailyMed

See drug prices for AMCINONIDE

Pharmacology for AMCINONIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for AMCINONIDE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for AMCINONIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus	AMCINONIDE	amcinonide	OINTMENT;TOPICAL	076096-001	Nov 19, 2002		RX	No	Yes
Genus Lifesciences	AMCINONIDE	amcinonide	CREAM;TOPICAL	076065-001	May 15, 2003	AB	RX	No	Yes
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astellas	CYCLOCORT	amcinonide	LOTION;TOPICAL	019729-001	Jun 13, 1988		DISCN	Yes	No
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Taro Pharm Inds	AMCINONIDE	amcinonide	OINTMENT;TOPICAL	076367-001	Mar 19, 2003		DISCN	No	No
Solubiomix	AMCINONIDE	amcinonide	LOTION;TOPICAL	076329-001	Nov 6, 2002		RX	No	Yes

Expired US Patents for AMCINONIDE

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

Market Dynamics and Financial Trajectory for Amcinonide

Last updated: February 14, 2026

Overview

Amcinonide is a potent corticosteroid used primarily in dermatology to treat inflammatory and allergic skin conditions. It is available under various brand names, including Cyclocort, and is marketed in multiple regions, notably the United States, Europe, and Asia. Its market performance relies heavily on dermatology needs, regulatory approvals, and patent statuses.

Market Size and Growth Drivers

The global dermatology market was valued at approximately $25 billion in 2022 and is projected to reach around $33 billion by 2027, with corticosteroid-based therapies constituting a significant segment. Amcinonide's share in this market is limited but stable, owing to the following factors:

• Prevalence of Dermatological Conditions: Conditions such as eczema, psoriasis, and dermatitis are widespread, increasing demand for corticosteroids.
• Prescribing Trends: Physicians prefer topical corticosteroids like Amcinonide for mild to moderate inflammatory skin conditions due to efficacy and safety profiles.
• Regulatory Environment: Regions with streamlined approval processes promote wider access to Amcinonide.

Competitive Landscape

Amcinonide faces competition from several other potent corticosteroids such as:

• Clobetasol propionate
• Betamethasone dipropionate
• Fluocinonide

Market share distribution is influenced by potency, formulation convenience, safety profiles, and patent status. Patent expirations typically trigger price competition and market consolidation.

Regulatory and Patent Status

• Patent Expiry: The key patents for Amcinonide have expired in many markets (e.g., US patent expiring around 2000), leading to increased generic competition.
• Regulatory Approvals: Widely approved for dermatological use; some regional differences exist in labeling and indications.

Revenue and Sales Trends

Despite generic competition, Amcinonide maintains a steady sales volume in niche markets and dermatology clinics. Estimated global sales are approximately $50-100 million annually. Price erosion due to generics has reduced per-unit revenue, but volume increases mitigate revenue decline slightly.

Financial Trajectory and Investment Considerations

• Pricing Dynamics: Generic entries drive prices downward over time. Branded versions may retain premium pricing where patents or exclusivities remain.
• Sales Growth: Growth is constrained by generics and competition. Regional expansion or new formulations could boost revenue.
• R&D and Pipeline: No significant pipeline for Amcinonide specifically; future opportunities may involve combination formulations or novel indications.

Market Risks and Opportunities

• Risks: patent expiration, competition from newer corticosteroids or biologics, regulatory hurdles.
• Opportunities: increased application in emerging markets, development of combination products, potential reformulation for improved safety.

Summary of Key Metrics

Metric	Data	Sources
Global dermatology market size	$25 billion (2022), projected $33 billion by 2027	[1]
Amcinonide annual sales	$50-$100 million	Industry estimates
Patent expiration	US patents expired pre-2000	[2]
Competition	Clobetasol, Betamethasone, Fluocinonide	Market analysis reports

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Key Takeaways

• Amcinonide is a niche corticosteroid with a mature, competitive market.
• Patents have expired globally, increasing generic competition.
• Revenues are stable but face downward pressure from price erosion.
• Growth opportunities focus on regional expansion and new formulations.
• Market risks include competition-driven declines and regulatory barriers.

FAQs

1. What is the current patent status of Amcinonide?
Most patents expired worldwide before 2005, leading to broad generic availability.

2. How does Amcinonide compare to other corticosteroids?
It offers similar potency but is less favored compared to high-potency options like Clobetasol for certain indications.

3. Which markets provide the highest revenue for Amcinonide?
The United States and Europe account for the majority of sales; emerging markets are growing but less lucrative currently.

4. Are there new formulations of Amcinonide in development?
No publicly known pipeline exists specifically for Amcinonide; future opportunities may involve combination products or alternative delivery methods.

5. How does competition affect the profitability of Amcinonide?
Generic competition reduces prices and margins but sustains volume, maintaining revenue streams for branded manufacturers.

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References

1. Market Research Future. "Global Dermatology Market Forecast," 2022.
2. U.S. Patent and Trademark Office. Patent expirations for corticosteroids, 2000–2005.