HYLENEX RECOMBINANT Drug Profile

Summary for Tradename: HYLENEX RECOMBINANT

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for HYLENEX RECOMBINANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYLENEX RECOMBINANT

Recent Clinical Trials for HYLENEX RECOMBINANT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
AstraZeneca	Phase 1
The Wistar Institute	Phase 1
Pablo Tebas	Phase 1

See all HYLENEX RECOMBINANT clinical trials

Recent Litigation for HYLENEX RECOMBINANT

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Halozyme, Inc. v. Lee	2016-12-19
Halozyme, Inc. v. Lee	2016-12-18

See all HYLENEX RECOMBINANT litigation

Pharmacology for HYLENEX RECOMBINANT

Established Pharmacologic Class	Endoglycosidase
Chemical Structure	Glycoside 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

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 HYLENEX RECOMBINANT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	7,767,429	2039-09-22	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	8,202,517	2023-03-05	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	8,431,124	2023-03-05	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	8,431,380	2023-03-05	Company disclosures

3) Low Certainty: US Patents for HYLENEX RECOMBINANT 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
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	11,414,489		Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	6,258,791	2017-05-29	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	8,273,721	2028-03-05	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	8,460,381	2039-02-26	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	9,278,124	2032-10-16	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	9,474,688	2031-10-25	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	9,511,123	2031-10-18	Patent claims search

International Patents for HYLENEX RECOMBINANT

Country	Patent Number	Estimated Expiration
Singapore	178799
South Korea	20120094493
Japan	5366407
Hong Kong	1109162
Spain	2526536
South Korea	20080004473
France	16C0030

Supplementary Protection Certificates for HYLENEX RECOMBINANT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016C/036	Belgium		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/98/067 20140328
C201530049	Spain		PRODUCT NAME: TRASTUZUMAB Y HIALURONIDASA HUMANA RECOMBINANTE; NATIONAL AUTHORISATION NUMBER: EU/1/100/145/002; DATE OF AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/100/145/002; DATE OF FIRST AUTHORISATION IN EEA: 20130826
PA2016022	Lithuania		PRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321
132016000070123	Italy		PRODUCT NAME: RITUXIMAB IN ASSOCIAZIONE CON IALURONIDASI RICOMBINANTE UMANA - SOLUZIONE PER INIEZIONE SOTTOCUTANEA(MABTHERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/98/067/001-003, 20140326
2015C/044	Belgium		PRODUCT NAME: LA COMBINAISON DE TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/00/145/002 20130828
93138	Luxembourg		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20140326
PA2015031	Lithuania		PRODUCT NAME: TRASTUZUMABAS IR REKOMBINANTINE ZMOGAUS HIALURONIDAZE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826

HYLENEX RECOMBINANT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hylenex Recombinant

Introduction

Hylenex® recombinant, a tissue permeability modifier developed by Halozyme Therapeutics, has been a significant player in the biologic drug market. This article delves into the market dynamics and financial trajectory of Hylenex recombinant, highlighting its uses, market performance, and the company's strategic moves.

What is Hylenex Recombinant?

Hylenex® recombinant (hyaluronidase human injection) is a formulation of recombinant human hyaluronidase (rHuPH20) that has received FDA approval. It is used as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, facilitate subcutaneous fluid administration, and improve resorption of radiopaque agents in subcutaneous urography[1][5].

Market Position and Growth

The global hyaluronidase market, in which Hylenex recombinant operates, was estimated at USD 909.5 million in 2022 and is anticipated to grow at a CAGR of 8.4% from 2023 to 2030. The recombinant human hyaluronidase segment, which includes Hylenex recombinant, is expected to register the fastest CAGR of 9.4% during this period due to its high efficacy, consistency, and purity[4].

Regional Dominance

North America, particularly the United States, dominates the hyaluronidase market, with a significant revenue share. This is attributed to the presence of major players like Halozyme Therapeutics, high adoption of advanced treatment options, and a substantial number of dermatology clinics prescribing such treatments[4].

Manufacturing and Supply Chain

Halozyme has expanded its manufacturing capabilities for Hylenex recombinant by receiving FDA approval for additional contract manufacturing facilities. The Cook Pharmica facility in Bloomington, Indiana, and the Patheon facility in Greenville, North Carolina, have been approved for the production of bulk rHuPH20 and finished Hylenex products, respectively. This expansion has enabled Halozyme to substantially increase its manufacturing capacity and ensure a continuous supply of the drug[1].

Financial Performance

Halozyme Therapeutics has seen significant financial growth driven by its ENHANZE® technology, which includes Hylenex recombinant. In 2020, the company reported record revenues of $267.6 million, a 37% increase from 2019. This growth was largely driven by milestone revenues under collaborative agreements and royalties from products utilizing ENHANZE® technology. The strong uptake of subcutaneous formulations like DARZALEX FASPRO® and DARZALEX® SC contributed significantly to the royalty revenue growth[2].

Strategic Collaborations

Halozyme has leveraged its ENHANZE® technology through strategic collaborations with several pharmaceutical companies. These collaborations have resulted in significant upfront milestone payments and ongoing royalty revenues. For example, the collaboration with argenx SE and Horizon Therapeutics plc has expanded Halozyme's pipeline and revenue streams. These partnerships have been crucial in driving the company's financial growth and positioning it for long-term sustainability[2].

Product Pipeline and Future Growth

Halozyme's focus on its ENHANZE® technology has led to multiple product launches and a robust pipeline. In 2020, two products utilizing ENHANZE® technology received FDA and European Commission approvals, contributing to the company's revenue growth. The company anticipates multiple waves of product launches in the 2023-2027 timeframe, which is expected to drive sustainable growth in revenues, profitability, and cash flow[2].

Competitive Landscape

The biologics market, including hyaluronidase, is increasingly competitive due to the emergence of biosimilars. However, Halozyme's focus on proprietary products and innovative technology has helped the company maintain a competitive edge. The preference for recombinant human hyaluronidase over animal-derived products due to its consistency and purity further supports Hylenex recombinant's market position[3][4].

Key Takeaways

• Market Growth: The hyaluronidase market is expected to grow at a CAGR of 8.4% from 2023 to 2030, with the recombinant segment growing at 9.4%.
• Regional Dominance: North America, particularly the U.S., dominates the market due to high adoption and presence of major players.
• Manufacturing Expansion: FDA-approved additional manufacturing facilities have increased Halozyme's production capacity.
• Financial Performance: Record revenues in 2020 driven by milestone payments and royalty growth.
• Strategic Collaborations: Key partnerships have expanded Halozyme's pipeline and revenue streams.
• Future Growth: Anticipated product launches and a robust pipeline position the company for long-term growth.

FAQs

Q: What is Hylenex recombinant used for? A: Hylenex recombinant is used as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, facilitate subcutaneous fluid administration, and improve resorption of radiopaque agents in subcutaneous urography.

Q: How has Halozyme expanded its manufacturing capacity for Hylenex recombinant? A: Halozyme has received FDA approval for additional contract manufacturing facilities, including the Cook Pharmica facility in Bloomington, Indiana, and the Patheon facility in Greenville, North Carolina.

Q: What drove Halozyme's financial growth in 2020? A: The growth was driven by milestone revenues under collaborative agreements and royalties from products utilizing ENHANZE® technology, particularly the strong uptake of subcutaneous formulations like DARZALEX FASPRO® and DARZALEX® SC.

Q: How does the competitive landscape affect Hylenex recombinant? A: Despite increasing competition from biosimilars, Hylenex recombinant maintains a competitive edge due to its proprietary technology and the preference for recombinant human hyaluronidase over animal-derived products.

Q: What are Halozyme's future growth prospects? A: Halozyme anticipates multiple waves of product launches in the 2023-2027 timeframe, driven by its robust pipeline and ongoing collaborations, positioning the company for sustainable growth in revenues, profitability, and cash flow.

Sources

1. Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex Recombinant. PR Newswire.
2. HALO 2020 - Annual Reports. Annual Reports.
3. The Rise of Biologics: Emerging Trends and Opportunities. CAS.org.
4. Hyaluronidase Market Size & Share Analysis Report, 2030. Grand View Research.
5. Halozyme Therapeutics, Inc. - Annual Reports. Annual Reports.