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

Recent Clinical Trials for HYLENEX RECOMBINANT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Pablo Tebas	Phase 1
Inovio Pharmaceuticals	Phase 1
United States Department of Defense	Phase 1

See all HYLENEX RECOMBINANT clinical trials

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 DrugPatentWatch Analysis and 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		2024-03-05	DrugPatentWatch analysis and company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2029-02-20	DrugPatentWatch analysis and company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2029-04-16	DrugPatentWatch analysis and company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2029-02-20	DrugPatentWatch analysis and 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		2037-02-27	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2019-11-29	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2029-03-04	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2031-03-31	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2033-10-16	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2032-10-25	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2032-10-18	Patent claims search

International Patents for HYLENEX RECOMBINANT

Country	Patent Number	Estimated Expiration
Japan	2013031446
Poland	1858926
Japan	2008531017
Australia	2006216545
Luxembourg	92780
Mexico	PA05009429
Cyprus	2016024

Supplementary Protection Certificates for HYLENEX RECOMBINANT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2016022	Lithuania		PRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321
132016000025345	Italy		PRODUCT NAME: TRASTUZUMAB PER USO SOTTOCUTANEO(HERCEPTIN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/00/145/002, 20130828
PA2015031	Lithuania		PRODUCT NAME: TRASTUZUMABAS IR REKOMBINANTINE ZMOGAUS HIALURONIDAZE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2015C/044	Belgium		PRODUCT NAME: LA COMBINAISON DE TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/00/145/002 20130828
2016C/036	Belgium		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/98/067 20140328
C20160022 00413	Estonia		PRODUCT NAME: RITUKSIMAB JS REKOMBINANTNE INIMESE HUEALURONIDAAS;REG NO/DATE: EU/1/98/067 26.03.2014
122015000061	Germany		PRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826

Market Dynamics and Financial Trajectory for the Biologic Drug: HYLENEX RECOMBINANT

Last updated: September 26, 2025

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Introduction

HYLENEX RECOMBINANT (hyaluronidase alpha, recombinant) represents a significant innovation within the biologic therapeutics landscape. Originally developed for facilitating subcutaneous drug administration, promoting tissue permeability, and aiding volume dispersal, HYLENEX has carved a niche in clinical and commercial markets. Understanding its market dynamics and financial trajectory requires an analysis of its therapeutic applications, competitive landscape, regulatory environment, and emerging market trends.

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Therapeutic and Clinical Application Scope

HYLENEX RECOMBINANT is primarily used to enhance the absorption and dispersion of co-administered drugs through subcutaneous tissue, facilitating easier and less painful injections. Its approved applications span:

• Subcutaneous drug delivery: Improving bioavailability of co-injected medications such as fluids, vaccines, and chemotherapy drugs.
• Pediatric and geriatric care: Offering minimally invasive administration options for vulnerable populations.
• Oncology: Enhancing infusion systems for chemotherapy and supportive care drugs.
• Allergy treatments: Facilitating allergy immunotherapy injections.

Despite its broad potential, its commercialization has experienced variability, influenced by clinical adoption rates, reimbursement policies, and competing technologies.

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Market Drivers

Increasing Preference for Subcutaneous Administrations

The shift from intravenous to subcutaneous methods propels demand for adjuvants like HYLENEX, which improve the efficiency and comfort of injections. The growing prevalence of chronic diseases such as cancer, rheumatoid arthritis, and diabetes further amplifies demand for streamlined biologic delivery systems.

Emergence of Biosimilars and Competition

Although HYLENEX is a recombinant enzyme, its market faces competition from other permeation enhancers and alternative bioavailability strategies, including microneedle patches and nanoparticle carriers. The lack of direct biosimilar competition for HYLENEX, however, provides a potential long-term market advantage.

Regulatory Approvals and Industry Adoption

FDA approval for specific infusion and dispersion indications underpins its commercialization. Increased physician familiarity and positive clinical data enhance its adoption in hospital and outpatient settings.

Ageing Demographics and Chronic Disease Burden

Global demographic shifts toward older populations drive the need for less invasive treatment options, boosting demand for products like HYLENEX that optimize drug delivery.

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Market Challenges

Limited Market Penetration and Awareness

Despite its clinical utility, HYLENEX remains underutilized, constrained by factors such as limited physician awareness, cost considerations, and the entrenched use of alternative techniques.

Pricing and Reimbursement Pressures

Pricing strategies for biologic adjuvants are under scrutiny from health insurers and government payers, impacting overall revenue potential. Reimbursement hurdles can restrict access in certain healthcare systems.

Technological Competition and Innovation

Competing modalities, including novel drug delivery systems like injectable nanoparticle carriers and wearable devices, threaten to diminish its market attractiveness.

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Regulatory Landscape

The regulation of biologic adjuvants centers on demonstrating safety, efficacy, and manufacturing quality. The U.S. FDA categorizes HYLENEX as a biologic under the Public Health Service Act, requiring rigorous biosafety and efficacy data for new indications. The evolving regulatory environment, especially regarding biosimilars and biologic licensing pathways, impacts future market expansion opportunities.

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Financial Trajectory Analysis

Historical Financial Performance

Since its initial approval, HYLENEX's revenue streams fluctuate, influenced by market penetration pace, addition of indications, and competitive shifts. The drug’s sales peaked during periods of high clinical adoption, with revenue affected by market saturation, reimbursement hurdles, and emergence of alternative technologies ([1]).

Revenue Projections and Growth Potential

Forecasts suggest moderate growth driven by expanding clinical applications, especially in oncology and outpatient infusion markets. The growth trajectory hinges on:

• Indication expansion: Securing approvals for additional therapeutic uses.
• Geographical penetration: Growth in emerging markets with increasing healthcare infrastructure.
• Partnership strategic alliances: Collaborations with healthcare companies to broaden distribution channels.

Analyst estimates project a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, contingent on regulatory success and market acceptance ([2]).

Profitability and Cost Considerations

Manufacturing costs for recombinant biologics, quality control, and distribution logistics contribute to profit margins. Streamlining production and leveraging economies of scale can enhance profitability. However, price pressures and reimbursement constraints may compress margins over time.

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Future Market Outlook

Technological Innovations

Emerging drug delivery technologies could supplement or replace the need for enzymes like HYLENEX, possibly constraining its growth. Conversely, product innovation—such as enhanced formulations with improved stability and efficacy—could revitalize market interest.

Regulatory and Policy Trends

Policy shifts favoring minimally invasive biologics and telehealth solutions could open new avenues. The evolution of reimbursement frameworks in key markets like the U.S. and EU remains pivotal.

Market Expansion Strategies

Expanding clinical indications, intensifying educational outreach, and pursuing strategic mergers or partnerships will be key growth tactics. Additionally, entering emerging markets with favorable healthcare investment climates could bolster revenues.

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Key Takeaways

• HYLENEX RECOMBINANT serves an essential niche in biologic drug delivery, with potential for growth through indication expansion and technological integration.
• Its market trajectory is moderated by competitive challenges, reimbursement complexities, and evolving technological landscapes.
• Global demographic trends favor minimally invasive therapies, bolstering demand in the coming decade.
• Strategic partnerships, regulatory approvals, and innovations in formulation are critical pillars for realizing its financial potential.
• Continued monitoring of reimbursement policies and technological advancements will shape its long-term market position.

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FAQs

1. What are the primary clinical applications of HYLENEX RECOMBINANT?
   It primarily facilitates subcutaneous drug absorption, enhances dispersion of co-administered medications, and is used in oncology, allergy immunotherapy, and pediatric care.

2. How does market competition impact HYLENEX’s growth prospects?
   While direct biosimilar competition is limited, alternative delivery technologies and permeation enhancers pose a threat, potentially restricting market expansion.

3. What regulatory hurdles exist for expanding HYLENEX’s indications?
   Regulatory agencies require robust clinical data demonstrating safety and efficacy for each new indication, which can delay commercialization and impact revenues.

4. What strategies could improve HYLENEX’s market penetration?
   Educational initiatives targeting clinicians, expanding indications, strategic partnerships, and pricing adjustments aligned with reimbursement policies can enhance market reach.

5. What is the forecasted financial trajectory for HYLENEX over the next five years?
   Expected modest growth with a CAGR of approximately 4-6%, driven by indications expansion, geographic diversification, and technological advancements.

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References

[1] Company annual reports and sales data, 2021-2022.
[2] Industry analyst forecasts and market reports, 2023.