APLISOL Drug Profile

Summary for Tradename: APLISOL

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for APLISOL

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Pharmacology for APLISOL

Physiological Effect	Cell-mediated Immunity
Established Pharmacologic Class	Skin Test Antigen Tuberculosis Skin Test
Chemical Structure	Antigens, Bacterial

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 APLISOL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Par Pharmaceutical Companies, Inc.	APLISOL	tuberculin, purified protein derivative	Injection	103782		2011-08-02	Patent claims search
Par Pharmaceutical Companies, Inc.	APLISOL	tuberculin, purified protein derivative	Injection	103782		2006-03-06	Patent claims search
Par Pharmaceutical Companies, Inc.	APLISOL	tuberculin, purified protein derivative	Injection	103782		2015-11-27	Patent claims search
Par Pharmaceutical Companies, Inc.	APLISOL	tuberculin, purified protein derivative	Injection	103782		2040-01-28	Patent claims search
Par Pharmaceutical Companies, Inc.	APLISOL	tuberculin, purified protein derivative	Injection	103782		2027-04-17	Patent claims search

APLISOL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Biologic Drug: APLISOL

Introduction to Biologic Drugs

Biologic drugs, including those like APLISOL, are a significant and growing segment of the pharmaceutical market. These drugs are derived from biological sources and have revolutionized the treatment of various diseases.

What is APLISOL?

APLISOL is a purified-protein derivative (PPD) tuberculin antigen used in performing tuberculin skin tests to diagnose tuberculosis. It is one of the two FDA-licensed products for this purpose, the other being Tubersol[4].

Market Position of APLISOL

Competitive Landscape

APLISOL operates in a niche market focused on tuberculosis diagnosis. The competitive landscape is relatively limited, with Tubersol being the primary competitor. However, the market dynamics are influenced by factors such as supply chain disruptions and regulatory approvals.

Supply Chain and Shortages

In recent years, APLISOL has faced significant supply chain issues. For instance, in 2019, the CDC announced a nationwide shortage of APLISOL due to manufacturing interruptions, which was expected to last between 3 to 10 months. This shortage highlighted the vulnerability of the supply chain for critical diagnostic tools like APLISOL[4].

Financial Trajectory

Revenue and Market Size

While specific financial data for APLISOL is not readily available, the broader biologic drugs market provides context. The global biological drugs market was valued at USD 296.2 billion in 2023 and is expected to grow to USD 326.12 billion by 2030, with a CAGR of 10.1%[3].

Pricing and Cost Considerations

The pricing of APLISOL can be influenced by several factors, including production costs, regulatory approvals, and market demand. For example, a change in tuberculin preparation from Tubersol to APLISOL at the San Diego Veterans Administration Medical Center was driven by pricing differences, indicating that cost is a significant factor in the market[5].

Regulatory Environment

FDA Approvals and Oversight

APLISOL, as a biologic product, is regulated by the FDA's Center for Biologics Evaluation and Research (CBER). Regulatory approvals and oversight play a crucial role in ensuring the safety and efficacy of the product. Any changes in regulatory frameworks can impact the market dynamics and financial trajectory of APLISOL[4].

Market Growth Drivers

Increasing Demand for Diagnostic Tools

The demand for diagnostic tools like APLISOL is driven by the need for accurate tuberculosis diagnosis. Global health initiatives and increasing awareness about tuberculosis contribute to the growing demand for such products.

Technological Advancements

Advancements in biotechnology and genetic engineering are driving innovation in the biologic drugs market. While APLISOL is a traditional product, advancements in diagnostic technologies could influence its market position and financial performance.

Challenges and Risks

Supply Chain Disruptions

As seen in the past, supply chain disruptions can significantly impact the availability and financial performance of APLISOL. Manufacturers must invest in robust supply chain management to mitigate such risks.

Regulatory Changes

Changes in regulatory frameworks can affect the market dynamics of biologic drugs. For instance, the Inflation Reduction Act in the US provides 13-year patent protection for new biologics, which could influence investment and innovation in the sector[3].

Regional Insights

Global Market

While APLISOL is primarily used in the US, the global biological drugs market is diverse. North America and Europe hold significant market shares, but regions like Asia-Pacific are experiencing rapid growth. This global perspective is crucial for understanding the broader market trends that could impact APLISOL's financial trajectory[3].

Key Takeaways

• Market Niche: APLISOL operates in a specialized market for tuberculosis diagnosis.
• Supply Chain Risks: Historical shortages highlight the need for robust supply chain management.
• Regulatory Oversight: FDA approvals and regulatory changes are critical for APLISOL's market position.
• Global Trends: The broader biologic drugs market is growing, driven by technological advancements and increasing demand for diagnostic tools.

FAQs

What is APLISOL used for?

APLISOL is a purified-protein derivative (PPD) tuberculin antigen used for performing tuberculin skin tests to diagnose tuberculosis.

Why did APLISOL face a shortage in 2019?

APLISOL faced a nationwide shortage in 2019 due to manufacturing interruptions, which were expected to last between 3 to 10 months.

How does the regulatory environment impact APLISOL?

The FDA's Center for Biologics Evaluation and Research (CBER) regulates APLISOL, and any changes in regulatory frameworks can impact its market dynamics and financial performance.

What are the key drivers of the biologic drugs market?

The biologic drugs market is driven by research and development activities, increasing prevalence of chronic diseases, and growing demand for personalized medicine.

How does the global market influence APLISOL's financial trajectory?

The global biological drugs market trends, including technological advancements and regional growth, can influence the financial performance and market position of APLISOL.

Sources

1. Biologics Market Dynamics: Setting the Stage for Biosimilars - FTC Workshop on a Competitive Marketplace for Biosimilars, March 9, 2020.
2. 10-K Filing - Tonix Pharmaceuticals Holding Corp. (TNXP) - Tonix Pharmaceuticals Holding Corp.
3. Biological Drugs Market: Global Industry Analysis - Maximize Market Research.
4. Nationwide Shortage of Tuberculin Skin Test Antigens - CDC - Centers for Disease Control and Prevention.
5. Tuberculin reaction size: Topics by Science.gov - Science.gov.