Hyaluronidase - Biologic Drug Details

Summary for hyaluronidase

Tradenames:	3
Patents:	4
Applicants:	4
BLAs:	4
Suppliers: see list	5
Recent Clinical Trials:	See clinical trials for hyaluronidase
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hyaluronidase

Recent Clinical Trials for hyaluronidase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Hoffmann-La Roche	Phase 3
Janssen, LP	Phase 2
Eastern Cooperative Oncology Group	Phase 2

See all hyaluronidase clinical trials

Recent Litigation for hyaluronidase

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC	2018-12-19
KYTHERA BIOPHARMACEUTICALS, INC. v. SLAYBACK PHARMA LLC	2018-11-08
Halozyme, Inc. v. Lee	2016-12-19

See all hyaluronidase litigation

PTAB Litigation

Petitioner	Date
	2017-05-30
	2017-01-31

See all hyaluronidase litigation

Pharmacology for hyaluronidase

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 hyaluronidase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for hyaluronidase 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		2039-09-22	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2023-03-05	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2023-03-05	Company disclosures

3) Low Certainty: US Patents for hyaluronidase 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
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2030-09-29	Patent claims search
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2033-03-11	Patent claims search
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2023-03-05	Patent claims search