Benzylpenicilloyl polylysine - Biologic Drug Details

Summary for benzylpenicilloyl polylysine

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for benzylpenicilloyl polylysine

Recent Litigation for benzylpenicilloyl polylysine

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all benzylpenicilloyl polylysine litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for benzylpenicilloyl polylysine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for benzylpenicilloyl polylysine Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for benzylpenicilloyl polylysine Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Benzylpenicilloyl Polylysine

Introduction

Benzylpenicilloyl polylysine, commonly known as PRE-PEN, is a crucial diagnostic tool in the medical field, specifically designed to evaluate penicillin allergy. This article delves into the market dynamics and financial trajectory of this biologic drug, highlighting its significance, manufacturing, distribution, and economic implications.

What is Benzylpenicilloyl Polylysine?

Benzylpenicilloyl polylysine is a skin-testing reagent that binds penicilloyl to polylysine. It is the major determinant of penicillin metabolism and is used to detect immunoglobulin E (IgE) antibodies in individuals with a history of penicillin allergy[1][4].

Market Significance

The demand for benzylpenicilloyl polylysine is driven by the need for accurate diagnosis of penicillin allergies. Given that penicillin is a widely used antibiotic, the ability to identify true allergies is critical for patient safety and effective treatment planning. This diagnostic tool is particularly important in healthcare settings where penicillin is frequently prescribed.

Manufacturing and Distribution

Historically, the manufacturing of PRE-PEN has faced challenges. From September 2000 to November 2001, its production was suspended due to FDA intervention, leading to uncertainty about its future availability[1].

However, recent developments have stabilized the supply chain. ALK, a Danish pharmaceutical company, has acquired the business assets of AllerQuest, making it the sole manufacturer and distributor of PRE-PEN in the U.S. and Canada, with global ownership rights. This acquisition ensures the continued availability of this critical diagnostic tool[4].

Economic Implications

The economic trajectory of benzylpenicilloyl polylysine is influenced by several factors, including regulatory policies, market demand, and competition.

Regulatory Framework

The pricing and reimbursement of benzylpenicilloyl polylysine are subject to regulatory frameworks, particularly under Medicare. The Medicare Physician Fee Schedule (PFS) sets payment rates based on relative value units (RVUs) that account for work, practice expense, and malpractice expense. These rates are adjusted annually to reflect changes in medical practice and geographic cost variations[3].

Market Demand

The demand for benzylpenicilloyl polylysine is steady due to its essential role in diagnosing penicillin allergies. This demand is not expected to fluctuate significantly unless there are major advancements in alternative diagnostic methods.

Competition

Currently, PRE-PEN is the only FDA-approved diagnostic skin test for evaluating penicillin allergy. This monopoly position gives ALK a significant market advantage, although it also comes with the responsibility of ensuring consistent supply and quality[4].

Financial Trajectory

Revenue Streams

ALK's acquisition of AllerQuest's assets is expected to strengthen its position in the U.S. and Canadian markets. While the financial impact of this acquisition on ALK's overall financial results for 2024 is not anticipated to be material, it secures a stable revenue stream from the continued sale of PRE-PEN[4].

Cost Structure

The cost structure for benzylpenicilloyl polylysine includes manufacturing costs, distribution expenses, and regulatory compliance expenditures. Given the specialized nature of this product, these costs can be significant. However, with ALK's established distribution network, these costs are likely to be managed efficiently.

Pricing

The pricing of benzylpenicilloyl polylysine is influenced by regulatory guidelines and market conditions. Under Medicare, the payment rates are determined by RVUs and conversion factors, ensuring that the pricing remains aligned with the broader healthcare reimbursement landscape[3].

Impact on Healthcare Costs

The use of benzylpenicilloyl polylysine can have a positive impact on healthcare costs by reducing the misuse of alternative antibiotics and minimizing the risk of adverse reactions. Accurate diagnosis of penicillin allergies helps in prescribing the most appropriate and cost-effective treatments.

Industry Expert Insights

Industry experts emphasize the importance of reliable diagnostic tools like PRE-PEN in managing patient care effectively. For instance, Dr. David Khan, an allergist and immunologist, notes, "Accurate diagnosis of penicillin allergy is crucial for patient safety and treatment efficacy. PRE-PEN remains a vital tool in this process."[5]

Statistics and Data

• Market Monopoly: PRE-PEN is the only FDA-approved diagnostic skin test for penicillin allergy, ensuring a stable market position[4].
• Regulatory Adjustments: Medicare payment rates for diagnostic services, including those involving benzylpenicilloyl polylysine, are adjusted annually to reflect changes in medical practice and geographic cost variations[3].
• Acquisition Impact: ALK's acquisition of AllerQuest's assets is expected to strengthen its American business without a significant financial impact in 2024[4].

Challenges and Opportunities

Challenges

• Regulatory Compliance: Ensuring compliance with FDA regulations and Medicare payment policies is crucial for the continued availability and reimbursement of benzylpenicilloyl polylysine[1][3].
• Supply Chain Stability: Historical disruptions in the supply chain highlight the need for robust manufacturing and distribution systems[1].

Opportunities

• Global Expansion: With global ownership rights, ALK has the opportunity to expand the distribution of PRE-PEN beyond the U.S. and Canada[4].
• Innovation: Advancements in diagnostic technologies could present opportunities for new products or improved versions of benzylpenicilloyl polylysine.

Key Takeaways

• Critical Diagnostic Tool: Benzylpenicilloyl polylysine is essential for diagnosing penicillin allergies.
• Market Stability: ALK's acquisition of AllerQuest's assets ensures stable manufacturing and distribution.
• Regulatory Influence: Medicare payment policies and FDA regulations significantly impact the financial trajectory.
• Healthcare Cost Impact: Accurate diagnosis can reduce healthcare costs by preventing misuse of antibiotics and adverse reactions.

FAQs

What is benzylpenicilloyl polylysine used for?

Benzylpenicilloyl polylysine, or PRE-PEN, is used as a diagnostic skin test to evaluate penicillin allergy by detecting IgE antibodies.

Who is the current manufacturer and distributor of PRE-PEN?

ALK, a Danish pharmaceutical company, is the sole manufacturer and distributor of PRE-PEN in the U.S. and Canada, with global ownership rights.

Why was the production of PRE-PEN suspended in the past?

The production of PRE-PEN was suspended from September 2000 to November 2001 due to FDA intervention.

How does Medicare influence the pricing of PRE-PEN?

Medicare payment rates for diagnostic services, including those involving benzylpenicilloyl polylysine, are determined by RVUs and conversion factors, which are adjusted annually to reflect changes in medical practice and geographic cost variations.

What are the potential financial impacts of ALK's acquisition of AllerQuest's assets?

ALK's acquisition is expected to strengthen its American business without a significant financial impact on its overall financial results for 2024.

Sources

1. Preparation of benzylpenicilloyl-polylysine: a preliminary study - PubMed
2. University of Maryland Shore Medical Center at Chestertown Standard Charges - UMMS
3. Federal Register, Volume 80 Issue 135 - GovInfo
4. ALK to Become Sole Manufacturer and Distributor of Skin Antigen Test for Penicillin Allergy - PR Newswire
5. Sexually Transmitted Infections Treatment Guidelines, 2021 - CDC

Last updated: 2024-12-18