Market Dynamics and Financial Trajectory for AK-FLUOR 25%
Introduction to AK-FLUOR
AK-FLUOR, a fluorescein sodium injection, is a critical diagnostic tool in ophthalmology, used for fluorescein angiography (FA) and angioscopy of the retina and iris vasculature. Originally approved by the FDA in 1976, it has been a staple in the ophthalmic diagnostic arsenal for decades[1][4].
Recent Market Disruptions
The market for AK-FLUOR has faced significant disruptions in recent times. In February 2023, Akorn Pharmaceuticals, the previous manufacturer of AK-FLUOR, announced its intention to file for bankruptcy. This led to the cessation of AK-FLUOR production and the recall of over 70 drugs from the U.S. market in May 2023. As a result, a shortage of AK-FLUOR in the United States began in April 2023[1][4].
Acquisition and Distribution
In June 2023, Long Grove Pharmaceuticals acquired the new drug application (NDA) for AK-FLUOR from Akorn Pharmaceuticals. To mitigate the shortage, Long Grove coordinated with the FDA to distribute the remaining inventory of AK-FLUOR that Akorn had manufactured prior to its closure. This move was crucial in ensuring some level of availability of the drug during the transition period[1][4].
Partnership with Keeler USA
Long Grove Pharmaceuticals has partnered with Keeler USA to distribute AK-FLUOR. This partnership aims to ease the procurement burdens of this essential ophthalmic drug. Through this agreement, Long Grove will relaunch AK-FLUOR under its own brand, marking a significant step in stabilizing the supply chain[1].
Competitive Landscape
The market for fluorescein sodium injection is not monopolized by Long Grove Pharmaceuticals. Other companies, such as Nexus Pharmaceuticals and Alcon, are also offering similar products. Nexus Pharmaceuticals launched a 10% fluorescein sodium injection in late October 2023 and plans to launch the 25% concentration in March 2024. Alcon has an adequate inventory of Fluorescite 10% injection and is scaling up production to meet higher demand[1][4].
Financial Implications
The financial trajectory of AK-FLUOR 25% is influenced by several factors, including production costs, distribution agreements, and market demand.
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Production Costs: The acquisition of the NDA and the coordination with the FDA to distribute existing inventory have likely incurred significant costs for Long Grove Pharmaceuticals. However, these costs are part of the company's strategy to ensure a consistent supply of the medication[1][4].
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Distribution Agreements: The partnership with Keeler USA involves listing the injection solution on both companies' websites and through specific distributors. The pricing, currently set at $876 for both dose concentrations, reflects the market dynamics and the costs associated with ensuring the drug's availability[1].
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Market Demand: The demand for AK-FLUOR remains high due to its essential role in ophthalmic diagnostics. The shortage created by Akorn's bankruptcy has highlighted the critical need for a stable supply chain. Long Grove's efforts to relaunch the product and other companies' entries into the market are expected to stabilize prices and ensure consistent availability[1][4].
Pricing and Availability
As of the current market situation, AK-FLUOR is available in two concentrations: 10% (100mg/mL in a 5mL single-dose vial) and 25% (250mg/mL in a 2mL single-dose vial). The pricing is uniform across these concentrations, with each pack costing $876. The distribution is managed through direct orders with Long Grove and its designated distributors, including AmerisourceBergen, Keeler USA, and Medigi[1].
Future Outlook
The future outlook for AK-FLUOR 25% is promising, given the proactive steps taken by Long Grove Pharmaceuticals and its partners.
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Relaunch and Supply Stability: The relaunch of AK-FLUOR under Long Grove's brand is expected to provide a consistent supply of the medication, alleviating the procurement burdens faced by healthcare providers[1].
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Market Competition: The entry of other manufacturers, such as Nexus Pharmaceuticals and Alcon, will likely keep prices competitive and ensure that the market remains dynamic and responsive to demand[1][4].
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Regulatory Compliance: Long Grove's coordination with the FDA ensures that the drug meets all regulatory standards, providing a high level of quality and safety for patients[1][4].
Key Takeaways
- Market Disruptions: The recent shortage of AK-FLUOR was caused by Akorn Pharmaceuticals' bankruptcy and cessation of production.
- Acquisition and Distribution: Long Grove Pharmaceuticals acquired the NDA for AK-FLUOR and is distributing the existing inventory in partnership with Keeler USA.
- Competitive Landscape: Other companies like Nexus Pharmaceuticals and Alcon are also offering fluorescein sodium injections.
- Financial Implications: The costs associated with the acquisition, distribution, and relaunch are significant but necessary to ensure a stable supply chain.
- Future Outlook: The relaunch under Long Grove's brand and market competition are expected to stabilize the supply and pricing of AK-FLUOR.
FAQs
Q: What is AK-FLUOR used for?
A: AK-FLUOR is used for diagnostic fluorescein angiography (FA) and angioscopy of the retina and iris vasculature.
Q: Why was there a shortage of AK-FLUOR?
A: The shortage was caused by Akorn Pharmaceuticals' bankruptcy and subsequent cessation of production.
Q: Who acquired the NDA for AK-FLUOR?
A: Long Grove Pharmaceuticals acquired the NDA for AK-FLUOR from Akorn Pharmaceuticals.
Q: How is AK-FLUOR being distributed currently?
A: AK-FLUOR is being distributed through a partnership between Long Grove Pharmaceuticals and Keeler USA, with orders managed through designated distributors.
Q: Are there other companies offering similar products?
A: Yes, companies like Nexus Pharmaceuticals and Alcon are also offering fluorescein sodium injections.
References
- Keeler USA, Long Grove Pharmaceuticals to distribute AK-FLUOR amidst US shortage. Glance.eyesoneyecare.com.
- Fluor Corporation's 2023 Integrated Report. Fluor.com.
- Fluorine and Fluorinated Motifs in the Design and Application of Bioisosteres for Drug Design. ACS Publications.
- Drug Shortage Detail: Fluorescein Sodium Injection. ASHP.org.
- The Effect of Imports of Steel on the National Security. Commerce.gov.
