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Last Updated: December 22, 2024

FLUOROPLEX Drug Patent Profile


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

Fluoroplex is a drug marketed by Chartwell Rx and Elorac and is included in two NDAs.

The generic ingredient in FLUOROPLEX is fluorouracil. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluoroplex

A generic version of FLUOROPLEX was approved as fluorouracil by FRESENIUS KABI USA on September 30th, 1998.

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Summary for FLUOROPLEX
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 216
Clinical Trials: 21
Patent Applications: 3,121
Drug Prices: Drug price information for FLUOROPLEX
What excipients (inactive ingredients) are in FLUOROPLEX?FLUOROPLEX excipients list
DailyMed Link:FLUOROPLEX at DailyMed
Drug patent expirations by year for FLUOROPLEX
Drug Prices for FLUOROPLEX

See drug prices for FLUOROPLEX

Recent Clinical Trials for FLUOROPLEX

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

SponsorPhase
University of ChicagoPhase 1
UNC Lineberger Comprehensive Cancer CenterN/A
National Cancer Institute (NCI)N/A

See all FLUOROPLEX clinical trials

US Patents and Regulatory Information for FLUOROPLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx FLUOROPLEX fluorouracil CREAM;TOPICAL 016988-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Elorac FLUOROPLEX fluorouracil SOLUTION;TOPICAL 016765-001 Approved Prior to Jan 1, 1982 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

FLUOROPLEX Market Analysis and Financial Projection Experimental

Fluoroplex: Market Dynamics and Financial Trajectory

Introduction to Fluoroplex

Fluoroplex, a topical cream containing fluorouracil, is a prescription medicine used primarily to treat multiple actinic (solar) keratosis, a condition characterized by the appearance of small, rough, scaly patches on the skin due to prolonged sun exposure. Here, we delve into the market dynamics and financial trajectory of Fluoroplex.

Market Size and Growth

The market for fluorouracil, including products like Fluoroplex, is experiencing significant growth driven by several factors.

  • Global Fluorouracil Market: The global fluorouracil market was valued at USD 2.45 billion in 2023 and is projected to reach USD 4.34 billion by 2030, growing at a CAGR of 7.7% from 2024 to 2030[1].

  • U.S. Actinic Keratosis Treatment Market: In the U.S., the actinic keratosis treatment market, where Fluoroplex is a key player, was valued at USD 2.39 billion in 2023 and is forecasted to reach USD 2.94 billion by 2030, growing at a CAGR of 3.03% from 2023 to 2030[4].

Market Drivers

Several factors are driving the growth of the Fluoroplex market:

Increasing Incidence of Actinic Keratosis

The rising incidence of actinic keratosis, particularly in regions with high sun exposure, is a significant driver. As the population ages and sun protection awareness increases, the demand for effective treatments like Fluoroplex is on the rise.

Strong Commercial Performance

Topical formulations like Fluoroplex, Carac, and Efudex have shown strong commercial performance due to their effectiveness in treating the initial stages of actinic keratosis. This has contributed to the dominance of nucleoside metabolic inhibitors in the market[4].

Research and Development

Pharmaceutical companies are investing heavily in research and development, which is expected to further boost the market. For instance, approvals like the European Commission's approval of ONIVYDE for metastatic pancreatic adenocarcinoma in combination with 5-fluorouracil and leucovorin highlight the ongoing innovation in fluorouracil-based treatments[1].

Market Segmentation

The market for Fluoroplex can be segmented in several ways:

By Geography

  • North America: This region dominates the fluorouracil market due to the high burden of cancer and non-communicable diseases. The U.S. is a significant contributor, with a high incidence of actinic keratosis and other skin conditions[1].

  • Europe, Asia Pacific, and Rest of the World: These regions also show promising growth, driven by increasing awareness and healthcare spending.

By Route of Administration

  • Topical: Fluoroplex is administered topically, which is a preferred route for treating actinic keratosis due to its localized action and minimal systemic side effects[2].

Competitive Landscape

The competitive landscape for Fluoroplex is dynamic, with several key players:

  • Aqua Pharmaceuticals: As the manufacturer of Fluoroplex, Aqua Pharmaceuticals plays a significant role in the market. The company's focus on dermatological treatments positions Fluoroplex as a leading brand in actinic keratosis treatment[2].

  • Other Market Players: Companies like Accord Healthcare, which launched a fluorouracil injectable in Australia, also contribute to the competitive landscape[1].

Financial Performance

The financial performance of the Fluoroplex market is robust and growing:

  • Revenue Growth: The U.S. actinic keratosis treatment market, where Fluoroplex is a major player, is expected to grow from USD 2.39 billion in 2023 to USD 2.94 billion by 2030[4].

  • Market Share: Fluorouracil-based treatments, including Fluoroplex, held a significant market share in 2022, with 31.28% of the AK drugs market in the U.S.[4].

Challenges and Restraints

Despite the growth, there are challenges and restraints to consider:

  • Side Effects: Fluoroplex can cause skin reactions, including redness, dryness, tenderness, and crusting of the skin. These side effects can be severe and may deter some patients[2].

  • Regulatory Approvals: The need for continuous regulatory approvals and compliance can be a restraint. For example, any changes in FDA regulations or labeling requirements can impact the market[2].

Key Takeaways

  • Growing Market: The global fluorouracil market and the U.S. actinic keratosis treatment market are experiencing significant growth.
  • Strong Commercial Performance: Topical formulations like Fluoroplex are driving market growth due to their effectiveness.
  • Geographical Dominance: North America, particularly the U.S., dominates the market due to high incidence rates of actinic keratosis.
  • Competitive Landscape: Aqua Pharmaceuticals and other players are key in the competitive landscape.
  • Financial Performance: The market is expected to grow substantially, with increasing revenue and market share.

FAQs

What is Fluoroplex used for?

Fluoroplex is a prescription medicine used to treat multiple actinic (solar) keratosis, a condition characterized by small, rough, scaly patches on the skin due to prolonged sun exposure[2].

What are the common side effects of Fluoroplex?

Common side effects include skin reactions such as redness, dryness, tenderness, and crusting of the skin. Other possible side effects include pain, irritation, darkening of the skin, itching, and scarring[2].

How is Fluoroplex administered?

Fluoroplex is administered topically, usually applied 2 times a day for 2 to 6 weeks, as instructed by a healthcare provider[2].

What is the market size of the global fluorouracil market?

The global fluorouracil market was valued at USD 2.45 billion in 2023 and is projected to reach USD 4.34 billion by 2030[1].

Who are the key players in the Fluoroplex market?

Aqua Pharmaceuticals, the manufacturer of Fluoroplex, is a key player. Other companies like Accord Healthcare also contribute to the market[1][2].

Sources

  1. Verified Market Research: Fluorouracil (5FU) Market Size & Forecast.
  2. FDA: FLUOROPLEX Cream Label.
  3. Annual Reports: Allergan Annual Report 2006.
  4. Grand View Research: U.S. Actinic Keratosis Treatment Market Size Report, 2030.

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