Hyaluronidase human - Biologic Drug Details

Summary for hyaluronidase human

Tradenames:	1
High Confidence Patents:	4
Applicants:	1
BLAs:	1
Suppliers: see list	3

Pharmacology for hyaluronidase human

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 human Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

3) Low Certainty: US Patents for hyaluronidase human 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		2017-05-29	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2028-03-05	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2039-02-26	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2032-10-16	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2031-10-25	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2031-10-18	Patent claims search

International Patents for hyaluronidase human

Country	Patent Number	Estimated Expiration
China	1942588
China	101163717
South Korea	101179029
Poland	1603541
Singapore	164386
Poland	2405015

Supplementary Protection Certificates for hyaluronidase human

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
93138	Luxembourg		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20140326
PA2016022	Lithuania		PRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321
122016000049	Germany		PRODUCT NAME: RITUXIMAB UND REKOMBINANTE HUMANE HYALURONIDASE; NAT. REGISTRATION NO/DATE: EU/1/98/067/003 20140321; FIRST REGISTRATION: EU EU/1/98/067/003 20140621
300753	Netherlands		PRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
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