AMPHADASE Drug Profile

Summary for Tradename: AMPHADASE

High Confidence Patents:	40
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for AMPHADASE
Recent Clinical Trials:	See clinical trials for AMPHADASE

See drug prices for AMPHADASE

Recent Clinical Trials for AMPHADASE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Amphastar Pharmaceuticals, Inc.	Phase 2

See all AMPHADASE clinical trials

Pharmacology for AMPHADASE

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 AMPHADASE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for AMPHADASE 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
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,065,005	2037-09-08	DrugPatentWatch analysis and company disclosures
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,252,002	2035-07-30	DrugPatentWatch analysis and company disclosures
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,328,157	2037-02-03	DrugPatentWatch analysis and company disclosures
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,413,627	2036-12-30	DrugPatentWatch analysis and company disclosures
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,413,628	2038-08-31	DrugPatentWatch analysis and company disclosures
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,485,890	2037-10-23	DrugPatentWatch analysis and company disclosures
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,688,176	2037-04-10	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for AMPHADASE 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
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,011,857	2036-03-31	Patent claims search
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,016,338	2036-12-20	Patent claims search
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,016,491	2035-11-09	Patent claims search
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,023,854	2032-09-14	Patent claims search
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,031,080	2036-06-03	Patent claims search
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,034,916	2033-06-12	Patent claims search
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10,052,389	2034-02-13	Patent claims search

International Patents for AMPHADASE

Country	Patent Number	Estimated Expiration
Singapore	177008
United Kingdom	0801088
Japan	2020521820
Israel	174489
Spain	2904256
Australia	2004278517
Singapore	164386

Supplementary Protection Certificates for AMPHADASE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132016000025345	Italy		PRODUCT NAME: TRASTUZUMAB PER USO SOTTOCUTANEO(HERCEPTIN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/00/145/002, 20130828
C20160022 00413	Estonia		PRODUCT NAME: RITUKSIMAB JS REKOMBINANTNE INIMESE HUEALURONIDAAS;REG NO/DATE: EU/1/98/067 26.03.2014
2016C/036	Belgium		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/98/067 20140328
2015C/044	Belgium		PRODUCT NAME: LA COMBINAISON DE TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/00/145/002 20130828
C02405015/01	Switzerland		PRODUCT NAME: RITUXIMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65813 28.06.2016
93138	Luxembourg		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20140326
C20150034 00412	Estonia		PRODUCT NAME: TRASTUZUMAB JA REKOMBINANTNE INIMESE HUEALURONIDAAS;REG NO/DATE: EU/1/00/145 28.08.2013

Market Dynamics and Financial Trajectory for Amphadase

Last updated: April 12, 2026

What is Amphadase?

Amphadase is a recombinant human hyaluronidase developed to enhance the tissue absorption of co-administered drugs and fluids. Its primary application is in facilitating the subcutaneous delivery of medications, including biologics, by degrading hyaluronic acid in the extracellular matrix.

Current Patent and Regulatory Status

• Patent protection extends to 2030, with key patents filed in the U.S. and Europe.
• It has secured approval in select markets for local anesthesia enhancement.
• Clinical development for indications such as drug absorption enhancement in biologics is ongoing or planned.

Market Scope

Amphadase's primary markets are:

• Hospital and outpatient infusion centers: used to improve subcutaneous drug administration.
• Biologic drug delivery: potential to increase bioavailability of monoclonal antibodies and other biologics via subcutaneous routes.

Competitive Landscape

• Hylase: a recombinant hyaluronidase similar to Amphadase, approved for certain applications.
• Vitrase: used in ophthalmology, with some off-label uses in drug absorption.
• Off-label uses of existing enzymes: such as Hylenex, a human recombinant hyaluronidase with broader indications.

Amphadase competes mainly on safety, efficacy, and regulatory approvals specific to its target indications. Its differentiation stems from formulation, purification techniques, and clinical data.

Market Drivers

• Growth in biologics: the global biologics market reached $480 billion in 2021, with an annual growth rate of approximately 12%. The shift from intravenous to subcutaneous delivery increases demand for absorption enhancers like Amphadase.
• Patient convenience: subcutaneous administration reduces treatment complexity compared to intravenous infusion.
• Regulatory trends: increasing approval of subcutaneous biologics encourages the development of adjunctive agents such as Amphadase.

Market Challenges

• Limited current indications: Amphadase’s existing approvals restrict its direct revenue potential.
• Pricing pressures: biosimilars and cost-effective alternatives place downward pressure on prices for absorption enhancers.
• Regulatory hurdles: additional clinical data required to expand indications, especially to demonstrate safety in biologic delivery.

Financial Trajectory Estimates

Revenue Projections

Year	Estimated Revenue (USD millions)	Assumptions
2023	10	Launch in select markets, initial adoption
2024	25	Expansion to additional centers, early clinical success
2025	50	Broader use in biologic delivery indications
2026+	100+	Potential approval for biologic indications nationwide

Cost and Investment Outlook

• Marketing expenses will increase to educate clinicians on Amphadase's benefits.
• Development costs for new indications estimated at USD 50 million over two years.
• Manufacturing investments enhance scale to meet rising demand.

Key Risks to Financial Growth

• Slow regulatory approval process for new indications.
• Competition from existing hyaluronidases with broader indications.
• Potential negative safety signals affecting adoption.

Market Entry and Expansion Strategies

• Clinical trials: emphasizing safety and efficacy in biologic drug absorption.
• Partnerships: with pharmaceutical companies to integrate Amphadase into biologic delivery platforms.
• Differentiation: through formulation improvements that extend shelf-life and reduce adverse effects.

Regulatory Trends Impacting Commercialization

• Increasing acceptance of subcutaneous biologic formulations.
• Patent extensions granted for biologic delivery technologies.
• Potential for regulatory incentives for facilitating biologic access in underserved populations.

Conclusion

Amphadase sits at the intersection of biologics growth and drug delivery innovation. Its financial success depends on expanding indications, securing regulatory approvals, establishing clinical value, and navigating competitive pressures.

Key Takeaways

• Amphadase’s revenue hinges on expanding approval for biologic drug delivery, with potential to reach USD 100+ million annually by 2026.
• Market growth is driven by increased biologic use and patient preference for subcutaneous administration.
• Regulatory and competitive challenges require targeted clinical development and strategic partnerships.

FAQs

Q1: What are the main differentiators of Amphadase compared to other hyaluronidases?
Amphadase’s unique formulation, manufacturing process, and safety profile distinguish it. Its approval status and clinical data also influence adoption.

Q2: When might Amphadase be approved for biologic drug delivery?
Clinical trials for this indication are ongoing, with potential approval expected within the next 2–3 years if data are supportive.

Q3: What are the key markets for Amphadase?
Hospitals, outpatient infusion centers, and pharmaceutical companies developing subcutaneous biologics.

Q4: How does the current competitive landscape affect Amphadase’s market potential?
Presence of similar enzymes like Hylase and Hylenex can impact pricing and market share; differentiation through clinical data and exclusive agreements will be critical.

Q5: What is the primary revenue risk for Amphadase?
Regulatory delays and failure to demonstrate safety and efficacy in new indications limit commercialization prospects.

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References

1. Grand View Research. (2022). Biologics Market Size, Share & Trends Analysis.
2. U.S. Food and Drug Administration. (2022). Approved drugs database: Hyaluronidase products.
3. MarketsandMarkets. (2021). Subcutaneous Drug Delivery Market.
4. European Medicines Agency. (2022). Regulatory updates on biologics and drug delivery agents.
5. PwC. (2022). Biologics industry outlook and pipeline analysis.