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Last Updated: December 22, 2024

AMPHADASE Drug Profile


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Recent Clinical Trials for AMPHADASE

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Amphastar Pharmaceuticals, Inc.Phase 2

See all AMPHADASE clinical trials

Recent Litigation for AMPHADASE

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Northwestern University v. Moderna, Inc.2024-10-16
Promosome LLC v. Moderna, Inc.2023-06-06
Janssen Biotech, Inc. v. Amgen Inc.2022-11-29

See all AMPHADASE litigation

PTAB Litigation
PetitionerDate
2017-05-30
2017-01-31

See all AMPHADASE litigation

Pharmacology for AMPHADASE
Established Pharmacologic ClassEndoglycosidase
Chemical StructureGlycoside Hydrolases
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 AMPHADASE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

AMPHADASE Market Analysis and Financial Projection Experimental

The Biologics Market and the Financial Trajectory of Biologic Drugs: A Focus on ENHANZE® (AMPHADASE)

Introduction

The biologics market is experiencing rapid growth, driven by several key factors including the increasing prevalence of chronic diseases, advancements in drug delivery systems, and the growing adoption of biosimilars. This article will delve into the market dynamics and financial trajectory of biologic drugs, with a specific focus on ENHANZE® (also known as AMPHADASE), a technology developed by Halozyme Therapeutics.

Biologics Market Outlook

The global biologics market is projected to grow significantly over the next decade. As of 2023, the market size was valued at USD 349.6 billion and is expected to reach USD 699.5 billion by 2032, with a compound annual growth rate (CAGR) of 7.8% during the 2024-2032 period[1].

Key Drivers of the Biologics Market

Several factors are driving the growth of the biologics market:

  • Increasing Burden of Chronic Diseases: The high prevalence of chronic diseases is a major driver, leading to increased demand for biologic therapies.
  • Technological Advancements: Continuous advancements in drug delivery systems and the development of targeted therapies are enhancing the market.
  • Growing Adoption of Biosimilars: Biosimilars are becoming more accepted, reducing costs and increasing accessibility.
  • Improved Healthcare Infrastructure: Investments in healthcare infrastructure, particularly in emerging economies, are boosting market growth.
  • Regulatory Approvals: The escalating approvals of biologics by regulatory agencies further fuel market expansion[1].

ENHANZE® Technology Overview

ENHANZE® is a proprietary drug delivery technology developed by Halozyme Therapeutics. This technology converts intravenous biologics to subcutaneous delivery, enhancing patient convenience and compliance.

How ENHANZE® Works

ENHANZE® uses recombinant human hyaluronidase (rHuPH20) to temporarily break down hyaluronan, a key component of the extracellular matrix, allowing for faster absorption of biologic drugs. This technology has been integrated into several biologic products, including DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and DARZALEX® SC (daratumumab)[3].

Financial Performance of Halozyme Therapeutics

Halozyme Therapeutics has seen significant financial growth driven by the success of its ENHANZE® technology.

Revenue Growth

In 2020, Halozyme reported total revenues of $267.6 million, a 37% increase from 2019. This growth was largely driven by milestone revenues under collaborative agreements and royalties from partner products using the ENHANZE® technology. Royalty revenues totaled $88.6 million, representing a 27% growth over the prior year[3].

Profitability

Halozyme achieved its first full year of profitability in 2020 with a net income of $129.1 million, or earnings per share of $0.91. This profitability was a result of strong revenue growth and the successful launch of new products by its partners[3].

Future Outlook

Halozyme is poised for continued growth with multiple product launches anticipated in the coming years. The company expects to see waves of product launches in the 2023-2025 and 2025-2027 timeframes, which will drive sustainable growth in revenues, profitability, and cash flow[3].

Market Impact of ENHANZE®

The ENHANZE® technology has significantly impacted the biologics market by:

  • Enhancing Patient Compliance: By converting intravenous biologics to subcutaneous delivery, ENHANZE® improves patient convenience and compliance.
  • Expanding Market Reach: The technology has enabled the launch of several biologic products in various markets, including the U.S. and EU.
  • Driving Revenue Growth: The success of ENHANZE®-enabled products has driven significant revenue growth for Halozyme and its partners[3].

Regional Market Dynamics

The biologics market, including products utilizing ENHANZE® technology, is influenced by regional dynamics:

Asia-Pacific

The Asia-Pacific region is a significant contributor to the biologics market due to its large patient population and growing healthcare infrastructure. Countries like China and India are investing heavily in biotechnology and R&D, driving market growth[1].

Latin America

In Latin America, increased healthcare access and rising healthcare expenditures are driving the biologics market. Countries such as Brazil and Mexico are investing in healthcare infrastructure, enhancing the distribution and availability of biologic therapies[1].

Middle East and Africa

The Middle East and Africa region is also experiencing growth, driven by increasing healthcare investments and a focus on advanced medical treatments. International collaborations and government initiatives to improve healthcare access are further contributing to market expansion[1].

Competitive Landscape

The biologics market is highly competitive, with several key players:

  • Halozyme Therapeutics: A leader in the conversion of intravenous biologics to subcutaneous delivery.
  • Other Biopharmaceutical Companies: Companies like Amphastar Pharmaceuticals are also making significant strides in the biologics market with their own product pipelines and technological advancements[2][3].

Conclusion

The biologics market is on a trajectory of rapid growth, driven by technological advancements, increasing demand for biologic therapies, and favorable market conditions. Halozyme Therapeutics' ENHANZE® technology has been a key player in this growth, enhancing patient compliance and driving revenue for the company and its partners.

Key Takeaways

  • The global biologics market is expected to reach USD 699.5 billion by 2032.
  • ENHANZE® technology has revolutionized biologic drug delivery by converting intravenous to subcutaneous administration.
  • Halozyme Therapeutics has achieved significant financial growth and profitability through its ENHANZE® technology.
  • Regional market dynamics, including growing healthcare infrastructure and increasing demand for biologics, are driving market expansion.

FAQs

Q: What is the projected growth rate of the biologics market from 2024 to 2032?

A: The biologics market is expected to grow at a CAGR of 7.8% from 2024 to 2032[1].

Q: How does ENHANZE® technology enhance biologic drug delivery?

A: ENHANZE® uses recombinant human hyaluronidase to break down hyaluronan, allowing for faster absorption of biologic drugs and converting intravenous administration to subcutaneous delivery[3].

Q: What were the key financial highlights for Halozyme Therapeutics in 2020?

A: Halozyme reported total revenues of $267.6 million, a 37% increase from 2019, and achieved its first full year of profitability with a net income of $129.1 million[3].

Q: Which regions are driving the growth of the biologics market?

A: The Asia-Pacific, Latin America, and Middle East and Africa regions are significantly contributing to the growth of the biologics market due to their large patient populations, growing healthcare infrastructure, and increasing healthcare investments[1].

Q: What is the impact of ENHANZE® technology on patient compliance?

A: ENHANZE® technology improves patient compliance by converting intravenous biologics to subcutaneous delivery, making treatment more convenient and less invasive[3].

Sources

  1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems - Biospace
  2. Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2024 - Stocktitan
  3. HALO 2020 - Annual Reports - AnnualReports.com
  4. Biologic Therapeutic Drugs: Technologies and Global Markets - BCC Research
  5. 2023 Annual Report - Q4cdn.com

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