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Last Updated: January 7, 2025

AKBETA Drug Patent Profile


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When do Akbeta patents expire, and when can generic versions of Akbeta launch?

Akbeta is a drug marketed by Epic Pharma Llc and is included in two NDAs.

The generic ingredient in AKBETA is levobunolol hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Akbeta

A generic version of AKBETA was approved as levobunolol hydrochloride by BAUSCH AND LOMB on March 4th, 1994.

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Summary for AKBETA
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 35
Patent Applications: 590
DailyMed Link:AKBETA at DailyMed
Drug patent expirations by year for AKBETA

US Patents and Regulatory Information for AKBETA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc AKBETA levobunolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 074779-001 Oct 29, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc AKBETA levobunolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 074780-001 Oct 29, 1996 DISCN 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

AKBETA Market Analysis and Financial Projection

Antibody Drug Conjugates (ADCs): Market Dynamics and Financial Trajectory

Introduction

Antibody Drug Conjugates (ADCs) are a revolutionary class of drugs that combine the targeting ability of monoclonal antibodies with the cytotoxic power of small molecules. This article delves into the market dynamics and financial trajectory of ADCs, focusing on key drivers, regional markets, and the performance of major players.

Market Size and Growth

The global ADC market was estimated at USD 11.29 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.2% from 2024 to 2030. This growth is driven by a robust research and development pipeline, increasing incidence of cancer, and a rising demand for low-toxicity and effective drugs[1].

Key Drivers of Market Growth

Robust R&D Pipeline

The presence of a robust R&D pipeline is a significant driver of the ADC market. Companies like Seagen, Inc., AstraZeneca, and Daiichi Sankyo are actively involved in developing and commercializing new ADC products. For instance, Seagen initiated phase 1 clinical trials of two novel drugs, SGN-B7H4V and SGN-PDL1V, in patients with advanced solid tumors in January 2022[1].

Increasing Incidence of Cancer

The growing incidence of cancer globally is another key factor driving the market. Cancer types such as breast cancer, which accounted for 47.76% of the market revenue in 2023, are seeing increased adoption of ADCs like Kadcyla, Trodelvy, and Enhertu[1].

Demand for Low-Toxicity Drugs

There is a rising demand for drugs that are less toxic and more effective. ADCs offer a targeted approach, reducing the side effects associated with traditional chemotherapy, which is a major draw for both patients and healthcare providers[1].

Regional Market Dynamics

North America

North America accounted for the largest revenue share of 52.54% in 2023. Factors such as high awareness among healthcare professionals, favorable reimbursement policies, significant R&D expenditure, and improved patient affordability are driving market growth in this region. The U.S. market, in particular, is growing due to FDA approvals for new indications, such as Gilead's Trodelvy for the treatment of adult patients with locally advanced or metastatic urothelial cancer[1].

Europe

The European market is also significant, driven by new product launches, increasing R&D initiatives, and potential products in the pipeline. The UK market, for example, is expected to grow due to rising awareness of cancer, increasing treatment adoption, and favorable reimbursement schemes by the National Institute for Health and Care Excellence (NICE)[1].

Japan

Japan is focusing on the geographic expansion of key players and the introduction of novel ADC medicines. Enhertu, for instance, was approved for the treatment of HER2-positive metastatic gastric cancer patients in Japan in September 2020. Japanese companies like Daiichi Sankyo are heavily investing in ADC development, with multiple products in the clinical pipeline[1].

Latin America

Latin America is identified as a lucrative regional market due to the high prevalence of cancer in countries like Mexico, driven by lifestyle changes and growing physical inactivity. However, the market growth here is slower compared to other regions due to unmet demand for insulin and other healthcare challenges[1].

Key Players and Collaborations

Major players in the ADC market include Seagen, Inc., Takeda Pharmaceutical Company Ltd., AstraZeneca PLC, F. Hoffmann-La Roche Ltd., Pfizer, Inc., and Daiichi Sankyo Company Ltd. These companies are engaging in significant collaborations and mergers and acquisitions to develop and commercialize ADC products. For example, AstraZeneca collaborated with Daiichi Sankyo in July 2020 to develop and commercialize new ADC products[1].

Financial Performance and Outlook

The financial performance of companies involved in the ADC market is promising. The market size is expected to reach USD 14.14 billion in 2024, up from USD 11.29 billion in 2023. Successful completion of clinical trials and subsequent approvals of new products are anticipated to drive market growth and revenue for these companies.

Revenue Projections

The global ADC market is projected to grow significantly over the next few years, driven by the factors mentioned above. The revenue growth is expected to be steady, with a CAGR of 9.2% from 2024 to 2030[1].

Investment and R&D Expenditure

Significant investments in R&D are a hallmark of the ADC market. Companies are spending heavily on developing new ADCs and expanding their product portfolios. This investment is expected to yield returns as new products gain approval and enter the market[1].

Clinical Trials and Regulatory Approvals

Clinical trials are a critical component of the ADC market. Successful trials and subsequent regulatory approvals are key to market growth. For instance, the FDA approval of Trodelvy for the treatment of adult patients with locally advanced or metastatic urothelial cancer in April 2021 boosted the market for this and other ADC drugs[1].

Market Challenges and Opportunities

Challenges

Despite the growth potential, the ADC market faces several challenges, including the high cost of development and the complexity of the manufacturing process. Additionally, regulatory hurdles and competition from other cancer therapies can impact market growth.

Opportunities

The ADC market presents several opportunities, particularly in emerging markets where there is a high prevalence of cancer and limited access to advanced treatments. The increasing awareness among healthcare professionals and favorable reimbursement policies in regions like North America and Europe also offer significant growth opportunities.

Key Takeaways

  • The global ADC market is projected to grow at a CAGR of 9.2% from 2024 to 2030.
  • The market is driven by a robust R&D pipeline, increasing incidence of cancer, and demand for low-toxicity drugs.
  • North America, Europe, and Japan are key regional markets.
  • Major players are engaging in collaborations and investments to develop and commercialize ADC products.
  • Successful clinical trials and regulatory approvals are crucial for market growth.

FAQs

What is the current market size of the global ADC market?

The global ADC market was estimated at USD 11.29 billion in 2023[1].

What is the projected CAGR for the global ADC market from 2024 to 2030?

The global ADC market is projected to grow at a CAGR of 9.2% from 2024 to 2030[1].

Which region holds the largest revenue share in the ADC market?

North America accounted for the largest revenue share of 52.54% in 2023[1].

What are some of the key drivers of the ADC market?

Key drivers include a robust R&D pipeline, increasing incidence of cancer, and demand for low-toxicity and effective drugs[1].

Which companies are major players in the ADC market?

Major players include Seagen, Inc., Takeda Pharmaceutical Company Ltd., AstraZeneca PLC, F. Hoffmann-La Roche Ltd., Pfizer, Inc., and Daiichi Sankyo Company Ltd.[1].

Sources

  1. Grand View Research: "Antibody Drug Conjugates Market Size | Industry Report 2030"
  2. PR Newswire: "Akebia Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights"
  3. BCC Research: "Antibody Drugs: Technologies and Global Markets - BCC Research"
  4. Fortune Business Insights: "Diabetes Drugs Market Share, Growth | Global Report [2032]"

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