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Last Updated: December 22, 2024

CLOBETASOL PROPIONATE (EMOLLIENT) Drug Patent Profile


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When do Clobetasol Propionate (emollient) patents expire, and what generic alternatives are available?

Clobetasol Propionate (emollient) is a drug marketed by Ani Pharms, Beach Prods, Fougera Pharms, and Taro. and is included in four NDAs.

The generic ingredient in CLOBETASOL PROPIONATE (EMOLLIENT) is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Clobetasol Propionate (emollient)

A generic version of CLOBETASOL PROPIONATE (EMOLLIENT) was approved as clobetasol propionate by COSETTE on February 16th, 1994.

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Summary for CLOBETASOL PROPIONATE (EMOLLIENT)
Drug patent expirations by year for CLOBETASOL PROPIONATE (EMOLLIENT)
Pharmacology for CLOBETASOL PROPIONATE (EMOLLIENT)

US Patents and Regulatory Information for CLOBETASOL PROPIONATE (EMOLLIENT)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075733-001 Aug 22, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075633-001 May 17, 2000 AB2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Beach Prods CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 209411-001 Aug 21, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera Pharms CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075430-001 May 26, 1999 AB2 RX No Yes ⤷  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

CLOBETASOL PROPIONATE (EMOLLIENT) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clobetasol Propionate (Emollient)

Introduction to Clobetasol Propionate

Clobetasol propionate is a potent corticosteroid widely used to treat various skin conditions, including eczema, psoriasis, and contact dermatitis, as well as post-operative inflammation and pain following ocular surgery. Its market dynamics are influenced by several key factors, including clinical efficacy, regulatory approvals, market competition, and patient needs.

Clinical Efficacy and Regulatory Approvals

Clobetasol propionate has demonstrated strong clinical efficacy, particularly in its emollient and ophthalmic formulations. The FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain following ocular surgery is a significant milestone. Clinical studies have shown that this formulation provides rapid and sustained clearance of inflammation and pain relief, with approximately 80% of patients experiencing complete relief from pain as soon as four days post-surgery, compared to 50% for the vehicle group[1].

The emollient cream formulation of clobetasol propionate 0.05% is also well tolerated and effective for up to 4 weeks in treating patients with psoriasis or atopic dermatitis. This formulation includes moisturizers such as emollients, dimethicone, and a humectant, which help restore the normal moisturizing process of the skin and improve treatment outcomes[5].

Market Size and Growth

The global clobetasol propionate market is projected to witness substantial growth, with a Compound Annual Growth Rate (CAGR) of 4.8% from 2023 to 2030. This growth is driven by increasing demand for effective treatments for skin conditions and post-operative care in ocular surgery. The market's expansion is also fueled by the emergence of new formulations and the strategic partnerships between key players[1][4].

Key Market Segments

By Application

The market is segmented into psoriasis, eczema, dermatitis, and other skin conditions. The ophthalmic segment, particularly for post-operative care, is emerging as a significant contributor to market growth. This segment benefits from the FDA-approved clobetasol propionate ophthalmic suspension, which offers a convenient dosing regimen without the need for tapering[1].

By Formulation

Clobetasol propionate is available in various forms, including creams, ointments, solutions, shampoos, and the latest addition, ophthalmic suspension. The emollient cream formulation is particularly notable for its ability to restore skin moisture and enhance treatment efficacy[1][5].

By Distribution Channel

The market is distributed through retail pharmacies, hospital pharmacies, and online pharmacies. Strategic partnerships, such as the one between Formosa Pharmaceuticals and Eyenovia for U.S. commercialization, are expected to enhance market reach and penetration[1].

Competitive Landscape

The clobetasol propionate market is highly competitive, with major players such as GlaxoSmithKline plc, Mylan N.V., Pfizer Inc, Zydus Cadila, LEO Pharma A/S, and others. New entrants like Formosa Pharmaceuticals and AimMax Therapeutics, with their proprietary APNT™ nanoparticle formulation platform, are expected to disrupt the market and capture significant market share. This platform offers enhanced delivery and efficacy, potentially setting a new standard of care in post-operative inflammation and pain management[1][4].

Regional Analysis

The market is geographically segmented into North America, South America, Asia-Pacific, Europe, and the Rest of the World. The ophthalmic steroid market in the United States alone serves a substantial patient population, with an estimated seven million ocular surgeries performed annually, providing a lucrative market opportunity. Other regions, such as Asia-Pacific and Europe, also present significant growth opportunities due to increasing healthcare spending and a rising prevalence of skin conditions[1][4].

Technological Advancements

The proprietary APNT™ nanoparticle formulation platform used in the new ophthalmic suspension represents a technological advantage. This platform enhances delivery and efficacy, offering rapid and sustained clearance of inflammation and pain relief. Such advancements are expected to influence market dynamics and prescribing habits, driving the adoption of newer formulations[1].

Financial Trajectory

Market Size

The global clobetasol propionate market is expected to grow significantly, with a projected CAGR of 4.8% from 2023 to 2030. This growth is driven by strong clinical outcomes and favorable market conditions[1][4].

Revenue Growth

The ophthalmic steroid market, valued at $1.3 billion, is expected to see rapid adoption and market penetration of the new clobetasol propionate ophthalmic suspension, contributing to revenue growth. The availability of the product at a low fixed price, regardless of insurance status, is seen as a positive factor by ophthalmic surgeons, potentially reducing managed care hurdles and increasing patient access[1].

Cost and Pricing

The cost of clobetasol propionate can vary based on factors such as treatment plan, insurance coverage, and the pharmacy used. However, the product's pricing strategy, including the option for a 90-day supply, is designed to reduce costs and improve patient compliance. This approach can help lower the number of trips to the pharmacy and reduce overall healthcare expenditures[3].

Key Takeaways

  • Strong Clinical Efficacy: Clobetasol propionate ophthalmic suspension 0.05% has demonstrated superior clinical outcomes, including rapid pain relief and inflammation clearance.
  • Market Growth: The global market is projected to grow at a CAGR of 4.8% from 2023 to 2030.
  • Technological Advancements: The proprietary APNT™ nanoparticle formulation platform offers enhanced delivery and efficacy.
  • Competitive Landscape: New entrants like Formosa Pharmaceuticals and AimMax Therapeutics are expected to disrupt the market.
  • Financial Trajectory: The market is valued at $1.3 billion, with significant revenue growth anticipated due to rapid adoption of the new ophthalmic suspension.

FAQs

Q: What is the FDA-approved product for post-operative inflammation and pain following ocular surgery? A: The FDA-approved product is clobetasol propionate ophthalmic suspension 0.05%[1].

Q: What are the common side effects of clobetasol propionate emollient cream? A: Common side effects include burning/stinging, pruritus, irritation, erythema, folliculitis, and skin atrophy. The incidence of local adverse reactions is generally less than 2%, except for burning/stinging, which occurs in about 5% of treated patients[2].

Q: How does the emollient formulation of clobetasol propionate enhance treatment outcomes? A: The emollient formulation includes moisturizers that help restore the normal moisturizing process of the skin, improving moisture content and enhancing the penetration of the steroid into the skin[5].

Q: What is the projected market growth rate for clobetasol propionate from 2023 to 2030? A: The global clobetasol propionate market is projected to grow at a CAGR of 4.8% from 2023 to 2030[1][4].

Q: Which regions are expected to contribute significantly to the growth of the clobetasol propionate market? A: North America, particularly the United States, and regions such as Asia-Pacific and Europe are expected to contribute significantly to market growth due to increasing healthcare spending and a rising prevalence of skin conditions[1][4].

Sources

  1. DrugPatentWatch: Clobetasol propionate - Generic Drug Details.
  2. DailyMed: Clobetasol Propionate Cream-Emollient, 0.05%.
  3. MedicalNewsToday: Clobetasol propionate and price.
  4. OpenPR: Clobetasol Propionate Market to Witness Stunning Growth with 4.8% CAGR.
  5. PubMed: The role of clobetasol propionate emollient 0.05% in the treatment of ...

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