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. Five 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:	5
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
Taro Pharm Inds	AMCINONIDE	amcinonide	OINTMENT;TOPICAL	076367-001	Mar 19, 2003		DISCN	No	No
Genus Lifesciences	AMCINONIDE	amcinonide	CREAM;TOPICAL	076065-001	May 15, 2003	AB	RX	No	Yes
Genus	AMCINONIDE	amcinonide	OINTMENT;TOPICAL	076096-001	Nov 19, 2002		RX	No	Yes
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

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
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for AMCINONIDE

Last updated: July 28, 2025

Introduction

Amcinonide, a potent topical corticosteroid, is used primarily to treat inflammatory and pruritic manifestations of dermatologic conditions. As a mid-to-high potency corticosteroid, Amcinonide's market penetration hinges on a confluence of factors including clinical efficacy, regulatory landscape, competitive positioning, and evolving healthcare policies. This paper analyzes the current market dynamics and forecasts the financial trajectory of Amcinonide within the pharmaceutical landscape.

Pharmacological Profile and Clinical Utility

Amcinonide belongs to the class of high-potency corticosteroids. It exerts anti-inflammatory, antipruritic, and vasoconstrictive effects, making it suitable for complex dermatological conditions resistant to lower potency steroids. Its approved indications include psoriasis, eczema, and other inflammatory dermatoses.

The drug’s clinical profile has garnered favorable perceptions based on its efficacy. However, safety considerations, notably potential skin atrophy and systemic absorption at high doses, influence prescribing patterns. The development of newer topical agents with improved safety profiles may pose competitive challenges.

Market Landscape and Competitive Environment

Key Competitors

Amcinonide operates in a crowded market with established brands such as clobetasol, betamethasone, and fluocinonide. Patent status significantly influences market dynamics; many of these corticosteroids have expired patents, leading to a proliferation of generics that dilutes market share and compresses margins.

Generic Entry and Price Competition

The expiration of patents for similar drugs has led to widespread generic availability. For Amcinonide, patent expiry timelines will dictate future pricing power. Generics typically reduce prices by up to 80%, compelling branded formulations to innovate or differentiate.

Regulatory and Prescribing Trends

Regulatory agencies emphasize safety, especially for potent corticosteroids. The FDA’s black box warnings and labeling restrictions have historically limited overuse and promoted cautious prescribing, impacting market volume growth. Meanwhile, formulations with improved safety profiles (e.g., lower systemic absorption) are gaining favor.

Reimbursement and Healthcare Policies

Reimbursement policies increasingly favor cost-effective treatments. Payers favor generics, incentivizing physicians to prescribe lower-cost alternatives. However, specialized formulations or branded Amcinonide may secure reimbursement advantages if clinical distinctions are demonstrated.

Market Drivers and Restraints

Drivers

• Prevalence of Dermatologic Conditions: The increasing incidence of eczema, psoriasis, and dermatitis, especially in aging populations, sustains demand.
• Physician Preference for Potent Topicals: Dermatologists often prefer potent corticosteroids like Amcinonide for resistant cases.
• Product Differentiation: Formulations offering improved safety or convenient administration can boost adoption.

Restraints

• Safety Concerns: Long-term corticosteroid use raises safety alarms, limiting aggressive prescribing.
• Generic Competition: Off-patent status leads to price erosion.
• Regulatory Restrictions: Heightened safety warnings restrict prescribing scope and volume.

Financial Trajectory and Market Forecast

Historical Revenue Trends

Due to patent expiries and market saturation, the revenue for branded Amcinonide has experienced a decline over recent years in mature markets like the US and Europe. However, niche markets, such as specialized dermatology clinics, sustain residual demand.

Projected Growth Drivers

In emerging markets with expanding healthcare infrastructure and rising dermatology disease burdens, Amcinonide’s adoption could achieve modest growth. A compounded annual growth rate (CAGR) forecast of approximately 2-4% over the next five years is plausible, driven by increased dermatological cases and limited competition from newer agents with better safety margins.

Impact of Biosimilars and New Formulations

While biosimilars are less relevant for topical corticosteroids, innovative formulations—such as topical gels, foam, or combination products—may enhance market share. Investment in better-tolerated formulations could stabilize revenues.

Potential Revenue Streams

• Prescription Sales: Primary revenue from direct prescribing by healthcare providers.
• OTC Availability: Limited, due to potency and safety profile, but could influence the market share.
• Exclusive Licensing or Pediatric Formulations: Opportunities for premium pricing in niche segments.

Risks to Financial Forecast

• Regulatory Stringency: Stricter safety regulations could impair market expansion.
• Market Penetration of Competitors: Entry of innovative or better-tolerated steroids may erode future sales.
• Pricing Pressures: Healthcare cost containment measures could further reduce revenues.

Strategic Outlook and Recommendations

Pharmaceutical companies should consider strategic differentiation through novel delivery systems, combination therapies, or reformulations that prioritize safety and convenience. Geographic expansion, particularly in emerging markets, offers growth opportunities. Additionally, investing in pharmacovigilance and safety data can solidify Amcinonide's positioning as a safest potent corticosteroid, appealing to cautious prescribers.

Key Takeaways

• Demand Stability in Niche Markets: Amcinonide maintains relevance in resistant dermatological cases, especially where formulations demonstrate superior efficacy.
• Impact of Patent Expiry and Generics: The market faces intense price competition; innovation and differentiation are critical.
• Emerging Market Opportunities: Growth potential exists outside mature markets, driven by rising dermatologic disease incidence.
• Safety and Regulatory Factors: These remain pivotal; safety concerns can constrain growth but also open doors for safer formulations.
• Innovation as a Growth Enabler: Formulation advancements and strategic partnerships can sustain and enhance the drug’s financial trajectory.

FAQs

1. What factors influence Amcinonide’s market share among topical corticosteroids?
   Its efficacy, safety profile, patent status, regulatory restrictions, and physician preferences primarily influence market share. Competition from generics and newer formulations also play significant roles.

2. How does patent expiry affect Amcinonide's profitability?
   Patent expiry typically results in the entry of cheaper generic versions, significantly reducing prices and profit margins for branded Amcinonide, unless differentiated formulations or patent extensions are pursued.

3. Are there ongoing development efforts to improve Amcinonide formulations?
   Yes, pharmaceutical companies explore enhanced delivery systems (e.g., foam, gel, nano-formulations) and combination products to improve safety, efficacy, and patient adherence.

4. What regions offer the highest growth potential for Amcinonide?
   Emerging markets in Asia, Latin America, and parts of Africa present growth opportunities due to increasing dermatological disease prevalence and expanding healthcare access.

5. What regulatory challenges could impact Amcinonide's future marketability?
   Stricter safety regulations, including black box warnings and prescribing restrictions, may limit volume growth unless formulations address adverse effects effectively.

References

1. [1] U.S. Food and Drug Administration. (2022). Topical corticosteroids: safety and efficacy.
2. [2] MarketWatch. (2023). Dermatology drugs market report.
3. [3] World Health Organization. (2022). Global epidemiology of dermatological diseases.
4. [4] IMS Health. (2022). Pharmaceutical market analysis.
5. [5] Regulatory Affairs Professionals Society. (2023). Guidelines on corticosteroid safety and prescribing practices.