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Last Updated: December 22, 2024

AMPHOTEC Drug Patent Profile


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When do Amphotec patents expire, and when can generic versions of Amphotec launch?

Amphotec is a drug marketed by Alkopharma Usa and is included in one NDA.

The generic ingredient in AMPHOTEC is amphotericin b. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amphotec

A generic version of AMPHOTEC was approved as amphotericin b by XGEN PHARMS on April 29th, 1992.

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Summary for AMPHOTEC
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 62
Clinical Trials: 1
DailyMed Link:AMPHOTEC at DailyMed
Drug patent expirations by year for AMPHOTEC
Recent Clinical Trials for AMPHOTEC

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1/Phase 2

See all AMPHOTEC clinical trials

US Patents and Regulatory Information for AMPHOTEC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkopharma Usa AMPHOTEC amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050729-001 Nov 22, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkopharma Usa AMPHOTEC amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050729-002 Nov 22, 1996 DISCN 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

AMPHOTEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AMPHOTEC (Amphotericin B Cholesteryl Sulfate Complex)

Introduction

AMPHOTEC, a lipid complex formulation of amphotericin B, is a critical antifungal medication used primarily for the treatment of invasive fungal infections, particularly in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B deoxycholate. Here, we delve into the market dynamics and financial trajectory of AMPHOTEC.

Market Size and Growth

The global amphotericin B market, which includes formulations like AMPHOTEC, is projected to grow significantly. As of 2022, the market size was USD 0.22 billion and is expected to reach USD 0.30 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period of 2023-2030[1].

Drivers of Market Growth

Several factors drive the growth of the amphotericin B market, including:

Increase in Fungal Infections

The rise in fungal infections, particularly among immunocompromised individuals and those with chronic diseases, increases the demand for effective antifungal drugs like AMPHOTEC[1].

Hospital-Acquired Infections

Hospital-acquired infections (HAIs) contribute to the demand for antifungal medications. HAIs can be caused by fungi and pose a significant challenge to healthcare systems, driving the need for treatments like AMPHOTEC[1].

Healthcare Expenditure and Government Initiatives

Increasing healthcare expenditure and government initiatives to spread awareness about fungal infections also boost the market for amphotericin B formulations[1].

Product Segment Dominance

The "static drops" segment dominates the product type category in the global amphotericin B market, but lipid complex formulations like AMPHOTEC are gaining traction due to their reduced toxicity and improved safety profile compared to conventional amphotericin B deoxycholate[1].

Regional Analysis

North America dominates the global amphotericin B market due to increasing healthcare initiatives, the strong presence of major players, and rising research activities in this region. Other significant markets include Europe, Asia-Pacific, and the Middle East and Africa[1].

Competitive Landscape

The market for amphotericin B, including AMPHOTEC, is competitive with several major players involved. The success of these formulations often depends on their ability to reduce toxicity while maintaining efficacy, as well as the strength of their distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies[1].

Financial Performance

The financial performance of AMPHOTEC is tied to the overall growth of the amphotericin B market. Here are some key financial aspects:

Revenue Growth

Given the projected growth of the amphotericin B market, formulations like AMPHOTEC are expected to contribute significantly to the revenue increase. The market is expected to grow from USD 0.22 billion in 2022 to USD 0.30 billion by 2030[1].

Pricing and Cost

The pricing of AMPHOTEC and other generic antifungal drugs is influenced by the number of competitors in the market. Studies have shown that generic drug prices decline with the number of competitors, approaching long-run marginal costs when there are eight or more competitors[3].

Research and Development

Rising R&D activities and clinical trials are expected to provide beneficial opportunities for the global amphotericin B market, including formulations like AMPHOTEC. These activities can lead to improved versions of the drug and expanded indications, further driving market growth[1].

Clinical and Safety Profile

AMPHOTEC is indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B deoxycholate. Clinical studies have shown that AMPHOTEC has a better safety profile, particularly in terms of renal function, compared to traditional amphotericin B formulations[4].

Pharmacokinetics

The pharmacokinetic parameters of AMPHOTEC, such as volume of distribution and total plasma clearance, have been studied extensively. These parameters indicate that AMPHOTEC has a favorable profile with less than proportional increases in plasma concentration over a dose range, reflecting tissue uptake[4].

Challenges and Opportunities

Despite the positive market dynamics, there are challenges and opportunities to consider:

Challenges

  • Side effects of amphotericin B, such as renal impairment and other toxicities, although reduced in lipid complex formulations like AMPHOTEC, still pose a challenge.
  • The rise in antifungal drug resistance is a significant concern that could impact market growth[1].

Opportunities

  • Growing unhygienic practices and emerging markets offer opportunities for increased demand.
  • Continuous R&D activities and clinical trials can lead to new indications and improved formulations, further expanding the market[1].

Key Takeaways

  • The global amphotericin B market, including AMPHOTEC, is expected to grow significantly, driven by increasing fungal infections and healthcare expenditure.
  • North America dominates the market due to strong healthcare initiatives and research activities.
  • The competitive landscape is influenced by the number of competitors and the safety profile of the drug.
  • Continuous R&D and clinical trials are crucial for market growth and addressing challenges like drug resistance.

FAQs

What is AMPHOTEC used for?

AMPHOTEC is used for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B deoxycholate[4].

How does the market size of amphotericin B project to grow?

The global amphotericin B market is expected to grow from USD 0.22 billion in 2022 to USD 0.30 billion by 2030, with a CAGR of 4.6% during the forecast period[1].

What are the main drivers of the amphotericin B market?

The main drivers include the rise in fungal infections, hospital-acquired infections, increasing healthcare expenditure, and government initiatives to spread awareness about fungal infections[1].

How does the number of competitors affect the pricing of generic antifungal drugs?

Generic drug prices decline with the number of competitors and approach long-run marginal costs when there are eight or more competitors[3].

What are the challenges facing the amphotericin B market?

Challenges include side effects of amphotericin B, such as renal impairment, and the rise in antifungal drug resistance[1].

Sources

  1. Data Bridge Market Research: Global Amphotericin B Market Size, Demand & Revenue Forecast By 2030.
  2. UCSF: 1978–1998: The Benet Chairship · History of the Department.
  3. Federal Trade Commission: Generic Drug Industry Dynamics.
  4. DailyMed: AMPHOTEC® Amphotericin B Cholesteryl Sulfate Complex for Injection.

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