ATGAM Drug Profile

Summary for Tradename: ATGAM

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for ATGAM

Mechanism of Action	Antibody-Surface Protein Interactions
Physiological Effect	Increased T Lymphocyte Destruction Lymphocyte Function Alteration
Established Pharmacologic Class	Immunoglobulin G
Chemical Structure	Immunoglobulins

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 ATGAM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for ATGAM 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
Pharmacia & Upjohn Company Llc	ATGAM	lymphocyte immune globulin, anti-thymocyte globulin (equine)	Injection	103676	10,064,938	2036-03-11	Patent claims search
Pharmacia & Upjohn Company Llc	ATGAM	lymphocyte immune globulin, anti-thymocyte globulin (equine)	Injection	103676	10,130,632	2039-02-26	Patent claims search
Pharmacia & Upjohn Company Llc	ATGAM	lymphocyte immune globulin, anti-thymocyte globulin (equine)	Injection	103676	10,570,103	2033-03-15	Patent claims search
Pharmacia & Upjohn Company Llc	ATGAM	lymphocyte immune globulin, anti-thymocyte globulin (equine)	Injection	103676	10,730,880	2034-12-05	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: ATGAM

Introduction

Anti-thymocyte globulin (ATGAM) is a biologic drug used in various medical applications, including the prevention of graft-versus-host disease (GVHD) in hematopoietic stem cell transplantation, treatment of acute kidney transplant rejection, and management of aplastic anemia. This article delves into the market dynamics and financial trajectory of ATGAM, highlighting its usage, economic implications, and future prospects.

Historical Context and Development

ATGAM, derived from horse antibodies, has been in use for several decades. It was first introduced as a treatment for acute rejection in organ transplantation and has since expanded to other immunological conditions[2].

Clinical Applications

Organ Transplantation

ATGAM is used to treat acute rejection in kidney transplant patients, particularly those who are corticosteroid-resistant. Studies have shown that ATGAM can be as effective as other antithymocyte globulins, such as Thymoglobulin, but with varying cost implications. For instance, Thymoglobulin has been found to offer significant cost savings compared to ATGAM due to fewer recurrent rejection treatments and less frequent return to dialysis[1].

Aplastic Anemia

In the treatment of aplastic anemia, ATGAM is often combined with cyclosporine A. Research indicates that lower doses of ATGAM can achieve similar response rates and survival outcomes as standard doses, suggesting flexibility in dosing protocols[2].

Graft-Versus-Host Disease

ATGAM is also used to prevent GVHD in hematopoietic stem cell transplantation. Low-dose ATGAM has been shown to reduce the incidence of chronic GVHD in recipients of matched unrelated donor grafts[2].

Market Size and Growth

The biologic therapeutic drugs market, which includes ATGAM, is projected to experience significant growth. According to recent market research, the global biologic therapeutic drugs market is expected to grow from $452.9 billion in 2023 to $823.4 billion by 2028, at a compound annual growth rate (CAGR) of 12.7% during the forecast period[3].

Economic Implications

Cost Analysis

The economic implications of using ATGAM versus other antithymocyte globulins are substantial. For example, a cost analysis comparing Thymoglobulin and ATGAM in treating acute kidney transplant rejection found that Thymoglobulin provided significant cost savings from the perspectives of society, Medicare, and transplant centers. This was primarily due to reduced costs associated with fewer recurrent rejection treatments and less frequent return to dialysis[1].

Competitive Dynamics

The market for solid organ transplant (SOT) acute therapy drugs, including ATGAM, is relatively small and has limited competition. This can lead to higher prices and reduced innovation, as seen in the case of the proposed acquisition between Genzyme and Ilex, which was deemed to cause significant competitive harm in the U.S. market for SOT acute therapy drugs[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of biologic drugs like ATGAM. Regulatory approvals and compliance are essential for maintaining market presence. Any changes in regulatory policies or the introduction of new competitors can significantly impact the market trajectory of ATGAM.

Future Prospects

Expanding Applications

Research continues to explore new applications for ATGAM, such as its potential in reducing myocardial necrosis and preserving cardiac function after acute myocardial infarction. These emerging uses could expand the market for ATGAM and contribute to its financial growth[2].

Market Competition

The biologic drugs market is highly competitive, with several key players. However, the specific niche of ATGAM in transplantation and immunological disorders provides a stable market position. The ongoing development of biologic therapies and the increasing demand for these drugs are expected to drive the market forward[3].

Key Takeaways

• Clinical Versatility: ATGAM is used in various clinical applications, including organ transplantation, aplastic anemia, and GVHD prevention.
• Economic Considerations: ATGAM's cost-effectiveness varies compared to other antithymocyte globulins, with significant cost savings observed with alternative treatments in some cases.
• Market Growth: The biologic therapeutic drugs market, including ATGAM, is projected to grow significantly, driven by increasing demand and advancements in biotechnology.
• Regulatory Impact: The regulatory environment is crucial for the market dynamics of ATGAM, influencing competition and innovation.

FAQs

What is ATGAM used for?

ATGAM is used to treat acute rejection in organ transplantation, manage aplastic anemia, and prevent graft-versus-host disease in hematopoietic stem cell transplantation.

How does ATGAM compare to Thymoglobulin in terms of cost?

Thymoglobulin has been found to offer significant cost savings compared to ATGAM, primarily due to fewer recurrent rejection treatments and less frequent return to dialysis[1].

What is the projected growth of the biologic therapeutic drugs market?

The global biologic therapeutic drugs market is expected to grow from $452.9 billion in 2023 to $823.4 billion by 2028, at a CAGR of 12.7% during the forecast period[3].

What are the potential new applications for ATGAM?

Research suggests potential new applications for ATGAM in reducing myocardial necrosis and preserving cardiac function after acute myocardial infarction[2].

How does the regulatory environment impact the market for ATGAM?

The regulatory environment can influence competition and innovation in the market for ATGAM. Changes in regulatory policies or the introduction of new competitors can significantly impact the market trajectory[4].

Sources

1. Economics of the antithymocyte globulins Thymoglobulin and Atgam ... - PubMed
2. horse anti-thymocyte globulin: Topics by Science.gov
3. Big Growth Ahead Biologic Drugs Market to Hit 823.4 Billion by 2028 - BCC Research
4. Genzyme Corp. - Federal Trade Commission - FTC.gov