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, 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:	4
NDAs:	8
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	53
Patent Applications:	5,984
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
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Genus	AMCINONIDE	amcinonide	LOTION;TOPICAL	076329-001	Nov 6, 2002		RX	No	Yes
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	AB	RX	No	Yes
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	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	4,158,055
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	Approved Prior to Jan 1, 1982	4,158,055

AMCINONIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amcinonide

Introduction

Amcinonide, a topical glucocorticoid marketed under the trade name Cyclocort, is widely used to treat various dermatological conditions characterized by itching, redness, and swelling. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its history, clinical significance, market trends, and future prospects.

History and Development

Amcinonide was first developed in the UK during the 1960s and 1970s and was later patented by American Cyanamid. Lederle Laboratories, known for discovering the tetracycline drug class, began manufacturing Amcinonide before being acquired by American Cyanamid. The drug was introduced to the market in 1979 and has since been distributed by various pharmaceutical companies, including Wyeth Pharmaceuticals and Pfizer, although Pfizer discontinued its production[1].

Clinical Significance

Amcinonide is classified as a multi-functional small molecule corticosteroid, approved by the FDA for treating dermatologic conditions. It acts as a transcription factor for glucocorticoid responses and modulates other transcription factors, while also regulating phospholipase A2 activity. Clinical trials have shown that Amcinonide is highly effective, with only 4.7% of patients reporting side effects. Studies comparing Amcinonide to other corticosteroids, such as Triamcinolone Acetonide, have found Amcinonide to be significantly more bio-active and potent[1][4].

Market Trends

The global topical corticosteroids market, within which Amcinonide operates, has been experiencing significant growth. In 2023, this market was valued at USD 4,270.71 million and is expected to grow to USD 6,102.07 million by 2030, with a Compounded Annual Growth Rate (CAGR) of 5.2%[3].

Drivers of Growth

• Increasing Prevalence of Dermatological Conditions: The rising incidence of eczema, psoriasis, and dermatitis is driving the demand for topical corticosteroids like Amcinonide.
• Growing Geriatric Population: The elderly are more prone to skin-related issues, further fueling the demand.
• Healthcare Awareness and Technological Advancements: Improved healthcare awareness and advancements in drug formulations have led to more effective and safer topical corticosteroids, enhancing therapeutic outcomes and patient compliance[3].

Restraints

• Side Effects: Concerns over the side effects of prolonged corticosteroid use, such as skin thinning and hormonal imbalances, are significant restraints.
• Regulatory Policies and High Treatment Costs: Strict regulatory policies and high treatment costs also pose barriers to market growth[3].

Commercialization and Production

Amcinonide is currently produced by several companies, including Taro Pharmaceuticals USA, Fougera (a subsidiary of Sandoz and Novartis), GlaxoSmithKline, and Teva Canada. These companies manufacture Amcinonide in various formulations such as ointments, creams, and lotions, all at a 0.1% strength. It is noteworthy that Amcinonide is only available as a prescription product and not as an over-the-counter medication[1].

Regulatory Approvals

Taro Pharmaceuticals obtained FDA approval for the production of Amcinonide cream in 2002, marking the first generic Amcinonide product in the United States. Fougera Pharmaceutical also gained FDA approval in 2003, introducing another competitor in the market. However, Taro faced regulatory issues in 2009 regarding non-sterile final products, which were later resolved[1].

Financial Trajectory

The financial trajectory of Amcinonide is closely tied to the overall growth of the global topical corticosteroids market. Here are some key financial insights:

Market Size and Growth

The global topical corticosteroids market, which includes Amcinonide, is expected to grow from USD 4,270.71 million in 2023 to USD 6,102.07 million by 2030. This growth is driven by increasing demand for effective treatments for dermatological conditions[3].

Pricing and Availability

The pricing of Amcinonide varies by formulation and manufacturer. For example, a 60 gm tube of Amcinonide 0.1% cream can cost around USD 84.29, while a 15 gm tube costs approximately USD 20.99. These prices indicate a competitive market with multiple manufacturers offering the drug at various price points[4].

Emerging Markets

Emerging markets, particularly in Asia and Latin America, offer significant potential for growth due to increasing disposable incomes and growing awareness about dermatological treatments. The rise of online pharmacies and advancements in telemedicine are also making these treatments more accessible, contributing to the financial growth of Amcinonide and similar drugs[3].

Key Takeaways

• Growing Demand: The demand for Amcinonide is driven by the increasing prevalence of dermatological conditions and a growing geriatric population.
• Competitive Market: Multiple manufacturers produce Amcinonide, ensuring a competitive market with various pricing options.
• Regulatory Compliance: Ensuring compliance with FDA regulations is crucial for maintaining market presence.
• Emerging Markets: Asia and Latin America offer significant growth opportunities due to increasing healthcare awareness and accessibility.

FAQs

What is Amcinonide used for?

Amcinonide is used to treat itching, redness, and swelling associated with various dermatologic conditions.

Who are the current manufacturers of Amcinonide?

Current manufacturers include Taro Pharmaceuticals USA, Fougera (a subsidiary of Sandoz and Novartis), GlaxoSmithKline, and Teva Canada.

What are the common formulations of Amcinonide?

Amcinonide is available as ointments, creams, and lotions, all at a 0.1% strength.

Is Amcinonide available over-the-counter?

No, Amcinonide is only available as a prescription product.

What are the potential side effects of Amcinonide?

Potential side effects include skin thinning and hormonal imbalances, although these are relatively rare.

Sources

1. Wikipedia: Amcinonide
2. MalaCards: Dermatitis
3. Reanin: Global Topical Corticosteroids Market
4. DrugBank: Amcinonide: Uses, Interactions, Mechanism of Action