PREDNICARBATE - Generic Drug Details

What are the generic sources for prednicarbate and what is the scope of freedom to operate?

Prednicarbate is the generic ingredient in three branded drugs marketed by Valeant Bermuda, Fougera Pharms, and Valeant Pharms North, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for prednicarbate. One supplier is listed for this compound.

Summary for PREDNICARBATE

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	1
Patent Applications:	7,001
Drug Prices:	Drug price trends for PREDNICARBATE
What excipients (inactive ingredients) are in PREDNICARBATE?	PREDNICARBATE excipients list
DailyMed Link:	PREDNICARBATE at DailyMed

See drug prices for PREDNICARBATE

Recent Clinical Trials for PREDNICARBATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Handok Inc.	Phase 4
Handok Pharmaceuticals Co., Ltd.	Phase 4

See all PREDNICARBATE clinical trials

Pharmacology for PREDNICARBATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PREDNICARBATE

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

US Patents and Regulatory Information for PREDNICARBATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	PREDNICARBATE	prednicarbate	OINTMENT;TOPICAL	077236-001	Mar 9, 2007		RX	No	Yes
Valeant Bermuda	DERMATOP E EMOLLIENT	prednicarbate	CREAM;TOPICAL	020279-001	Oct 29, 1993		DISCN	Yes	No
Valeant Pharms North	DERMATOP	prednicarbate	OINTMENT;TOPICAL	019568-001	Sep 23, 1991		DISCN	Yes	No
Fougera Pharms	PREDNICARBATE	prednicarbate	CREAM;TOPICAL	077287-001	Sep 19, 2006		DISCN	No	No

Expired US Patents for PREDNICARBATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Bermuda	DERMATOP E EMOLLIENT	prednicarbate	CREAM;TOPICAL	020279-001	Oct 29, 1993	4,242,334
Valeant Pharms North	DERMATOP	prednicarbate	OINTMENT;TOPICAL	019568-001	Sep 23, 1991	4,242,334

PREDNICARBATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prednicarbate

Introduction

Prednicarbate, a medium potency topical corticosteroid, is widely used for managing pruritus and inflammation associated with various skin conditions, including atopic dermatitis and eczema. This article delves into the market dynamics and financial trajectory of prednicarbate, highlighting its efficacy, cost-effectiveness, and market positioning.

Efficacy and Clinical Use

Prednicarbate is recognized for its anti-inflammatory, antipruritic, and vasoconstrictive properties. It acts by inhibiting the release of arachidonic acid, thereby reducing the biosynthesis of prostaglandins and leukotrienes, which are potent mediators of inflammation[4].

Clinical Studies

Studies have shown that prednicarbate has a favorable efficacy profile compared to other topical corticosteroids. For instance, a meta-analysis comparing prednicarbate with fluocortin in the treatment of inflammatory dermatoses found that prednicarbate had an effectiveness rate of 84.9%, significantly higher than fluocortin's 69.7%[1].

Cost-Effectiveness

The cost-effectiveness of prednicarbate is a crucial factor in its market dynamics. The same meta-analysis mentioned above revealed that prednicarbate had a lower total expected cost per patient treated compared to fluocortin. The cost per patient treated with prednicarbate was approximately 4600 Spanish pesetas (about $37.10 USD in 1996), whereas fluocortin cost around 5778 Spanish pesetas (about $46.60 USD in 1996)[1].

Economic Assessment

The economic assessment included not only the cost of the medication but also the costs associated with ineffectiveness and adverse effects. Prednicarbate demonstrated a favorable cost-effectiveness ratio, making it a more economically viable option for treating dermatitis and eczema[1].

Market Positioning

Prednicarbate is positioned as a medium potency topical corticosteroid, which places it in a competitive but niche market.

Brand Names and Generic Availability

Prednicarbate is available under several brand names, including Dermatop, and is also available in generic form. This availability helps in maintaining a competitive pricing strategy[4].

Pricing

The pricing of prednicarbate varies based on the formulation (cream or ointment) and the quantity. For example, a 60 gm tube of prednicarbate 0.1% cream can cost around $75.20 USD, while a 15 gm tube can cost approximately $24.00 USD[4].

Regulatory and Approval Aspects

Prednicarbate has been approved for use in various countries for the treatment of inflammatory skin diseases.

Approval Criteria

Regulatory bodies often update approval criteria based on new evidence and market dynamics. For instance, updates in approval criteria for topical corticosteroids can impact the market positioning of prednicarbate[3].

Patient and Physician Preferences

Patient and physician preferences play a significant role in the market dynamics of any medication.

Safety Profile

Prednicarbate is known for its favorable safety profile, with a low potential to cause skin atrophy compared to other topical corticosteroids. This makes it a preferred choice among both patients and physicians[4].

Patient Education

Effective patient education on the use and benefits of prednicarbate can enhance its market acceptance. Educating patients about the signs and symptoms of skin conditions and the importance of early treatment can increase the demand for prednicarbate[2].

Market Trends and Future Outlook

The market for topical corticosteroids is influenced by several trends and factors.

Biosimilars and Generics

The increasing availability of generic and biosimilar versions of topical corticosteroids can impact the pricing and market share of branded products like prednicarbate. However, prednicarbate's established efficacy and safety profile help it maintain a strong market position[5].

Pharmacoeconomic Studies

Additional pharmacoeconomic studies are necessary to further establish the cost-effectiveness of prednicarbate, especially in the context of long-term treatment and quality of life improvements. These studies can provide valuable insights for healthcare providers and payers[1].

Financial Impact

The financial impact of prednicarbate on healthcare systems is significant, given its widespread use.

Aggregate Costs

The aggregate costs associated with the use of prednicarbate, including the cost of the medication and the management of adverse effects, are generally lower compared to other topical corticosteroids. This makes it a financially attractive option for both patients and healthcare systems[1].

Reimbursement and Insurance

Reimbursement policies and insurance coverage also influence the financial trajectory of prednicarbate. In regions where prednicarbate is covered by insurance, its market demand tends to be higher[3].

Key Takeaways

• Efficacy: Prednicarbate has a high effectiveness rate in treating inflammatory skin conditions.
• Cost-Effectiveness: It offers a favorable cost-effectiveness ratio compared to other topical corticosteroids.
• Market Positioning: Positioned as a medium potency topical corticosteroid with a strong safety profile.
• Pricing: Competitive pricing due to generic availability.
• Regulatory Aspects: Approved for use in various countries with ongoing updates in approval criteria.
• Patient and Physician Preferences: Preferred due to its safety profile and efficacy.
• Market Trends: Influenced by the availability of generics and biosimilars, and the need for further pharmacoeconomic studies.

FAQs

What is prednicarbate used for?

Prednicarbate is used to manage pruritus and inflammation associated with responsive skin conditions such as atopic dermatitis and eczema.

How does prednicarbate compare to other topical corticosteroids in terms of cost-effectiveness?

Prednicarbate has been shown to have a favorable cost-effectiveness ratio compared to other topical corticosteroids, such as fluocortin, due to its higher efficacy and lower costs associated with adverse effects.

What are the common side effects of prednicarbate?

Prednicarbate has a low potential for side effects, with the most common being skin atrophy, although this is less frequent compared to other topical corticosteroids.

Is prednicarbate available in generic form?

Yes, prednicarbate is available in both branded and generic forms, which helps in maintaining competitive pricing.

How does the pricing of prednicarbate vary?

The pricing of prednicarbate varies based on the formulation (cream or ointment) and the quantity, with larger quantities generally being more cost-effective.

Sources

1. Prednicarbate versus fluocortin for inflammatory dermatoses. A cost-effectiveness analysis. PubMed.
2. Safety Profile and Select Treatment‐Related Adverse Events From the CheckMate 040 Study of Nivolumab in Patients With Advanced Hepatocellular Carcinoma. Oxford Academic.
3. Drug Utilization Review Board - Oklahoma.gov.
4. Prednicarbate: Uses, Interactions, Mechanism of Action - DrugBank.
5. Thematic poster session (TPS) - 2024 - Allergy - Wiley Online Library.