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Last Updated: December 22, 2024

Triamcinolone hexacetonide - Generic Drug Details


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What are the generic drug sources for triamcinolone hexacetonide and what is the scope of patent protection?

Triamcinolone hexacetonide is the generic ingredient in one branded drug marketed by Anika Theraps Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for triamcinolone hexacetonide.

Summary for triamcinolone hexacetonide
Recent Clinical Trials for triamcinolone hexacetonide

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

SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)N/A
Oslo University HospitalPhase 4
Diakonhjemmet HospitalPhase 4

See all triamcinolone hexacetonide clinical trials

US Patents and Regulatory Information for triamcinolone hexacetonide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anika Theraps Inc ARISTOSPAN triamcinolone hexacetonide INJECTABLE;INJECTION 016466-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Anika Theraps Inc ARISTOSPAN triamcinolone hexacetonide INJECTABLE;INJECTION 016466-002 Approved Prior to Jan 1, 1982 DISCN Yes 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

Triamcinolone hexacetonide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triamcinolone Hexacetonide

Introduction

Triamcinolone hexacetonide, a synthetic corticosteroid, is widely used for its anti-inflammatory properties, particularly in treating various skin conditions, inflammatory disorders, and osteoarthritis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The triamcinolone market, which includes triamcinolone hexacetonide, was valued at USD 874.2 million in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.4% from 2024 to 2032, reaching a projected value of USD 1.2 billion by 2032[1].

Segmentation and Market Share

By Type

The market is segmented into various forms such as creams, injections, inhalers, and others. The cream segment held the majority of the market share in 2023 and is anticipated to grow at a CAGR of 3.6% over the coming years[1].

By Application

The triamcinolone market is classified into applications such as eczema, dermatitis, allergies, psoriasis, and others. The eczema segment dominated the market with a revenue of about USD 377.7 million in 2023[1].

By End-user

The market is segmented into drug stores, hospitals, and other end-users. Drug stores secured a leading share of about 66.2% in 2023 and are anticipated to grow at a CAGR of 3.7% during the forecast period[1].

Regional Analysis

North America

North America accounted for 40.5% of the global market share in 2023 and is predicted to reach USD 458.9 million by 2032. The U.S. market, specifically, was valued at USD 305.9 million in 2023 and is expected to grow at a CAGR of 3.2% over the forecast period[1].

Europe and Asia

Germany is expected to show significant growth during the forecast period, while India is anticipated to grow remarkably over the coming years, driven by increasing awareness and regulatory approvals[1].

Key Drivers and Challenges

Drivers

  • Increasing Prevalence of Skin Conditions: The growing prevalence of skin conditions such as eczema, dermatitis, and psoriasis is driving the demand for triamcinolone hexacetonide.
  • Regulatory Approvals: The growth in regulatory approvals of new and advanced triamcinolone formulations is positively impacting the market[1].
  • Modernization in Drug Application: Advances in nasal drug applications and the development of new formulations like CINGAL, which combines triamcinolone hexacetonide with hyaluronic acid, are expanding the market[2].

Challenges

  • Market Fragmentation: The triamcinolone market is highly fragmented due to the presence of numerous generic manufacturers, which can lead to pricing pressures and competition.
  • Regulatory Hurdles: The process of obtaining full FDA marketing authorization can be lengthy and challenging, as seen with Medexus's efforts to commercialize triamcinolone hexacetonide in the U.S.[4].

Financial Performance of Key Players

Medexus Pharmaceuticals

Medexus entered into an exclusive agreement with Ethypharm for the rights to register and commercialize triamcinolone hexacetonide injectable suspension in the U.S. in December 2020. Despite facing a shortage, the company received special authorization from the FDA to import and sell the product. Medexus reported a record revenue of USD 79.7 million in fiscal 2021, with a 43.5% year-over-year growth, though the company faced increased selling and administrative expenses[4].

Anika Therapeutics

Anika Therapeutics is developing CINGAL, a viscosupplement that combines triamcinolone hexacetonide with hyaluronic acid. The product has shown superior short-term pain relief and long-term efficacy in clinical trials. Anika's efforts to complete pivotal Phase III trials and secure FDA approval are critical to their financial trajectory[2].

Clinical Efficacy and Impact

Intra-Articular Administration

Studies have shown that intra-articular administration of triamcinolone hexacetonide provides significant relief from osteoarthritis-related pain, stiffness, and functional impairment. The mean duration of effect in patients with osteoarthritis is around seven months, highlighting its clinical efficacy[5].

Nasal Applications

The triamcinolone acetonide nasal market, which includes formulations of triamcinolone, is expected to grow at a CAGR of 6.2% from 2022 to 2029, driven by the growing prevalence of nasal allergies and modernization in nasal drug applications[3].

Competitive Landscape

The triamcinolone market is characterized by a high level of fragmentation, with numerous generic manufacturers operating alongside larger pharmaceutical companies. Established players like Medexus and Anika Therapeutics leverage their marketing and sales expertise to maintain a leading market share. Outsourcing manufacturing to contract manufacturers in developing countries helps reduce costs and maintain competitiveness[1].

Key Takeaways

  • Growing Market: The triamcinolone market is expected to grow at a CAGR of 3.4% from 2024 to 2032.
  • Segmentation: The market is segmented by type, application, and end-user, with creams and eczema treatment being dominant segments.
  • Regional Growth: North America, particularly the U.S., and regions like Germany and India are expected to show significant growth.
  • Clinical Efficacy: Triamcinolone hexacetonide has proven efficacy in treating various conditions, including osteoarthritis and skin disorders.
  • Regulatory and Competitive Dynamics: Regulatory approvals and competitive strategies by key players are crucial for market growth.

FAQs

What is the projected market size of triamcinolone by 2032?

The triamcinolone market is expected to reach USD 1.2 billion by 2032[1].

Which segment dominates the triamcinolone market by application?

The eczema segment dominates the market with a significant revenue share[1].

What is the CAGR of the triamcinolone acetonide nasal market from 2022 to 2029?

The triamcinolone acetonide nasal market is expected to exhibit a CAGR of 6.2% from 2022 to 2029[3].

What is the primary use of triamcinolone hexacetonide in osteoarthritis treatment?

Triamcinolone hexacetonide is used for intra-articular administration to provide relief from osteoarthritis-related pain, stiffness, and functional impairment[5].

Which company is developing CINGAL, a viscosupplement combining triamcinolone hexacetonide with hyaluronic acid?

Anika Therapeutics is developing CINGAL[2].

Sources

  1. GMI Insights: Triamcinolone Market 2024 – 2032 Industry Growth Report
  2. Anika Therapeutics: Anika Completes Enrollment in Second Pivotal Phase III Trial of CINGAL
  3. Business Research Insights: Triamcinolone Acetonide Nasal Market Size, Trends, 2024 - 2032
  4. Medexus Pharmaceuticals: Medexus Revenue Increases 43.5% to a Record US$79.7 Million for Fiscal 2021
  5. PLOS ONE: The intra-articular administration of triamcinolone hexacetonide in patients with hip osteoarthritis

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