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Last Updated: December 22, 2024

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for hydrocortisone acetate; pramoxine hydrochloride and what is the scope of freedom to operate?

Hydrocortisone acetate; pramoxine hydrochloride is the generic ingredient in four branded drugs marketed by Mylan Speciality Lp, Genus, Sebela Ireland Ltd, and Ferndale Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Pharmacology for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs

US Patents and Regulatory Information for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride CREAM;TOPICAL 083778-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride CREAM;TOPICAL 085368-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Speciality Lp EPIFOAM hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086457-001 Approved Prior to Jan 1, 1982 BX RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085980-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Speciality Lp PROCTOFOAM HC hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086195-001 Approved Prior to Jan 1, 1982 BX RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ferndale Labs PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 083213-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085979-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocortisone Acetate and Pramoxine Hydrochloride

Introduction

Hydrocortisone acetate and pramoxine hydrochloride are widely used in various medical formulations, particularly for their anti-inflammatory, anti-pruritic, and anesthetic properties. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

The market for hydrocortisone acetate and pramoxine hydrochloride is driven by the increasing prevalence of skin conditions, inflammatory diseases, and anorectal disorders. Here are some key aspects of the market:

Demand Drivers

  • Skin Conditions: The rising incidence of corticosteroid-responsive dermatoses, such as eczema, psoriasis, and allergic dermatitis, fuels the demand for hydrocortisone acetate formulations[1][3][5].
  • Anorectal Disorders: Conditions like inflamed hemorrhoids, post-irradiation proctitis, and chronic ulcerative colitis drive the demand for suppository forms of these drugs[2][3].

Market Segmentation

  • Topical Preparations: Creams, ointments, and foams containing hydrocortisone acetate and pramoxine hydrochloride are widely used for skin conditions.
  • Suppositories: Used for anorectal conditions, these are a significant segment of the market[2].

Competitive Landscape

The market for hydrocortisone acetate and pramoxine hydrochloride is competitive, with several pharmaceutical companies offering various formulations.

Key Players

  • Generic and Branded Products: Companies like Pfizer, Johnson & Johnson, and generic manufacturers offer a range of products under different brand names such as Alcortin A, Analpram HC, and Anusol HC[3].
  • Market Share: Established brands hold a significant market share, but generic versions are increasingly popular due to their cost-effectiveness.

Financial Trajectory

The financial performance of hydrocortisone acetate and pramoxine hydrochloride formulations can be analyzed through several lenses:

Revenue Growth

  • The market has seen steady revenue growth driven by the increasing demand for these medications. The global market for topical corticosteroids, which includes hydrocortisone acetate, is expected to grow at a moderate CAGR due to the rising prevalence of skin diseases and anorectal conditions[1][3].

Cost and Pricing

  • Generic Competition: The entry of generic versions has led to competitive pricing, which can impact the revenue of branded products. However, the overall market size has expanded due to increased accessibility and affordability[3].
  • Prescription vs. OTC: Prescription formulations tend to have higher prices compared to over-the-counter (OTC) versions, influencing the financial trajectory of these drugs.

Geographical Performance

  • Developed Markets: In regions like North America and Europe, the market is more mature, with a higher penetration of branded and generic products.
  • Emerging Markets: In countries like India, China, and Brazil, there is a growing demand for these medications due to increasing healthcare spending and awareness about skin and anorectal conditions.

Regulatory Environment

The regulatory landscape plays a crucial role in the market dynamics and financial performance of these drugs.

Approval and Compliance

  • Prescription Requirements: In many countries, hydrocortisone acetate and pramoxine hydrochloride combinations are available only by prescription, which can affect sales and distribution channels[1][2].
  • Safety and Efficacy: Regulatory bodies closely monitor the safety and efficacy of these drugs, and any changes in guidelines or warnings can impact market performance.

Technological Advancements

Advancements in formulation technology and analytical methods are enhancing the market for these drugs.

Formulation Innovations

  • Stability and Efficacy: New formulations and delivery systems, such as creams and suppositories with improved stability and efficacy, are being developed to enhance patient compliance and treatment outcomes[4][5].

Analytical Methods

  • Quality Control: Advanced analytical methods like UHPLC and HPLC are being used to ensure the quality and purity of these medications, which is critical for regulatory compliance and market acceptance[4].

Challenges and Opportunities

The market for hydrocortisone acetate and pramoxine hydrochloride faces several challenges and opportunities:

Side Effects and Safety Concerns

  • Systemic Absorption: The potential for systemic absorption and side effects like HPA axis suppression and Cushing's syndrome can impact market growth and necessitate careful monitoring and dosage adjustments[1][5].

Market Expansion

  • Emerging Markets: There is significant potential for growth in emerging markets where healthcare infrastructure is improving and demand for effective treatments for skin and anorectal conditions is increasing.
  • New Indications: Research into new indications for these drugs could expand their market reach and financial potential.

Key Takeaways

  • Growing Demand: The market for hydrocortisone acetate and pramoxine hydrochloride is driven by increasing demand for treatments of skin and anorectal conditions.
  • Competitive Landscape: The market is competitive with both branded and generic products available.
  • Regulatory Compliance: Adherence to regulatory guidelines is crucial for market success.
  • Technological Advancements: Innovations in formulations and analytical methods are enhancing market performance.
  • Challenges and Opportunities: Managing side effects and expanding into emerging markets are key challenges and opportunities.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of hydrocortisone acetate and pramoxine hydrochloride? A: These drugs are used to relieve redness, itching, swelling, and other discomfort caused by skin conditions and anorectal disorders.

Q: Are hydrocortisone acetate and pramoxine hydrochloride available over-the-counter? A: Some formulations are available OTC, but many require a prescription, especially for more potent or specialized uses.

Q: What are the potential side effects of long-term use of these drugs? A: Long-term use can lead to systemic absorption, causing side effects like HPA axis suppression, Cushing's syndrome, and other systemic issues.

Q: How do generic versions impact the market for these drugs? A: Generic versions increase competition, leading to lower prices and expanded market accessibility but can reduce the revenue of branded products.

Q: What role do regulatory bodies play in the market for these drugs? A: Regulatory bodies ensure the safety and efficacy of these drugs through strict guidelines and monitoring, which can impact market performance and product availability.

Cited Sources:

  1. Mayo Clinic: Hydrocortisone and pramoxine (topical application route)[1].
  2. Drugs.com: Hydrocortisone and Pramoxine Suppository[2].
  3. DrugBank: Hydrocortisone acetate[3].
  4. ScienceDirect: Novel stability indicating UHPLC method development and validation for simultaneous quantification of hydrocortisone acetate, pramoxine hydrochloride, potassium sorbate and sorbic acid in topical cream formulation[4].
  5. DailyMed: Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream[5].

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