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Last Updated: December 29, 2024

PROBALAN Drug Patent Profile


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Which patents cover Probalan, and what generic alternatives are available?

Probalan is a drug marketed by Lannett and is included in one NDA.

The generic ingredient in PROBALAN is probenecid. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the probenecid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Probalan

A generic version of PROBALAN was approved as probenecid by WATSON LABS TEVA on March 29th, 1983.

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Drug patent expirations by year for PROBALAN
Recent Clinical Trials for PROBALAN

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SponsorPhase
National Institutes of Health (NIH)Early Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Early Phase 1
Washington State UniversityEarly Phase 1

See all PROBALAN clinical trials

US Patents and Regulatory Information for PROBALAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett PROBALAN probenecid TABLET;ORAL 080966-001 Approved Prior to Jan 1, 1982 AB RX 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

PROBALAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Probalan

Introduction

Probalan, known generically as probenecid, is a medication used primarily in the treatment of chronic gout and gouty arthritis. This article delves into the market dynamics and financial trajectory of Probalan, examining its usage, pricing, and the broader pharmaceutical market trends that influence its position.

Uses and Mechanism of Probalan

Probalan is an antigout agent that works by increasing the excretion of uric acid from the body, thereby reducing uric acid levels in the blood. It is often prescribed to prevent gout attacks rather than to treat them once they have started[2].

Market Context: Gout Treatment Landscape

The gout treatment market is complex, with various medications and treatment strategies. Probalan is one of the older drugs in this space, but it remains relevant due to its effectiveness in managing chronic gout. The market for gout treatments is growing, driven by increasing prevalence and the need for effective management strategies[4].

Pricing and Cost Dynamics

The pricing of Probalan is relatively stable compared to some other gout medications. For instance, while colchicine prices skyrocketed after the FDA approval of Colcrys in 2009, Probalan has maintained a more affordable price point. In 2017, the price of probenecid-colchicine combination was around $0.66 per pill, significantly lower than the prices of single-ingredient colchicine formulations like Colcrys[1].

Impact of FDA Regulations and Market Exclusivity

The FDA's Unapproved Drug Initiative has significantly impacted the pricing and availability of certain gout medications. For example, the approval of Colcrys led to a virtual monopoly on colchicine, resulting in drastic price increases. However, Probalan, being an older drug with established generic versions, has not faced similar price hikes. This makes it a more accessible option for patients[1].

Pharmaceutical Spending Trends

Overall pharmaceutical spending is expected to rise in the coming years. For 2024, prescription drug spending is projected to increase by 10.0% to 12.0%, with significant growth anticipated in clinics and hospitals. This trend is driven by factors such as increased utilization, new drug approvals, and price increases[3].

Utilization and Prescribing Patterns

Probalan's utilization remains stable, particularly in the context of gout treatment. It is often prescribed in combination with other medications to enhance their effectiveness. For example, it is used with certain antibiotics to improve their efficacy and with colchicine to manage gout more effectively[2].

Side Effects and Safety Profile

While Probalan is generally well-tolerated, it can cause side effects such as stomach upset, skin rash, and in rare cases, more severe reactions. These side effects are managed through proper dosing and patient monitoring, ensuring that the benefits of the medication outweigh the risks[2].

Competitive Landscape

The gout treatment market is competitive, with various drugs available, including newer therapies and biosimilars. However, Probalan's long history and established efficacy make it a reliable choice for many healthcare providers. The market assessment for chronic refractory gout highlights the need for effective and affordable treatments, where Probalan fits well due to its cost-effectiveness and proven track record[4].

Unmet Needs and Emerging Therapies

Despite the availability of Probalan and other treatments, there are still unmet needs in gout management. Emerging therapies and new drug approvals are expected to address these gaps, but Probalan remains a cornerstone in the treatment regimen for many patients. The pipeline analysis for gout treatments indicates a focus on efficacy, safety, and delivery metrics, areas where Probalan has already established its value[4].

Financial Projections and Spending

Given the stable pricing and consistent utilization of Probalan, its financial trajectory is relatively predictable. While overall pharmaceutical spending is increasing, Probalan's affordability helps it maintain a stable market position. The significant increase in spending on other gout medications, such as colchicine, highlights the financial burden that high-priced drugs can impose on healthcare systems, making Probalan a more attractive option from a cost perspective[1][3].

Value and Access

The value of Probalan lies in its ability to provide effective gout management at a lower cost compared to newer or branded medications. This makes it accessible to a wider patient population, particularly those who may not be able to afford more expensive treatments. The evidence supporting its value is crucial for communicating its benefits to healthcare providers, payers, and regulators[4].

Key Takeaways

  • Stable Pricing: Probalan's price remains relatively stable, making it an affordable option for gout management.
  • Established Efficacy: It has a proven track record in reducing uric acid levels and preventing gout attacks.
  • Market Context: The gout treatment market is growing, with Probalan maintaining a significant position due to its cost-effectiveness.
  • Pharmaceutical Spending Trends: Overall spending on pharmaceuticals is increasing, but Probalan's stable pricing helps it remain a viable option.
  • Unmet Needs: Despite its effectiveness, there are still unmet needs in gout management, which emerging therapies aim to address.

FAQs

What is Probalan used for?

Probalan, or probenecid, is used in the treatment of chronic gout or gouty arthritis by removing excess uric acid from the body.

How does Probalan work?

Probalan works by increasing the excretion of uric acid from the body, thereby reducing uric acid levels in the blood.

What are the common side effects of Probalan?

Common side effects include stomach upset, skin rash, and in rare cases, more severe reactions such as fast or irregular breathing and shortness of breath.

How does the pricing of Probalan compare to other gout medications?

Probalan is significantly cheaper than some other gout medications like colchicine, particularly after the FDA approval of Colcrys led to a drastic price increase for colchicine.

What are the financial projections for Probalan in the pharmaceutical market?

Given its stable pricing and consistent utilization, Probalan's financial trajectory is relatively predictable and stable, despite overall increases in pharmaceutical spending.

Sources

  1. McCormick, N., et al. "Prolonged Increases in Public-Payer Spending and Prices After Approval of Colcrys (Colchicine)." JAMA Internal Medicine, 30 Nov. 2020, doi:10.1001/jamainternmed.2020.5017.
  2. "Probalan Advanced Patient Information - Drugs.com." Drugs.com, 19 May 2024.
  3. "National trends in prescription drug expenditures and projections for 2024." PubMed, 8 Jul. 2024.
  4. "Gout (Chronic Refractory) Market Assessment 2024 Featuring 15 Companies and 20 Key Drugs." GlobeNewswire, 30 Sep. 2024.
  5. Freis, E. D., & Sappington, R. F. "Long-Term Effect of Probenecid on Diuretic-Induced Hyperuricemia." JAMA, 1966, doi:10.1001/jama.1966.03110150075021.

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