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Hyaluronidase - Biologic Drug Details

Tradenames:	3
Patents:	493
Applicants:	3
BLAs:	3
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for hyaluronidase
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hyaluronidase

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Sponsor	Phase
Takeda	Phase 1/Phase 2
Brigham and Women's Hospital	Early Phase 1
Academic and Community Cancer Research United	Phase 2

Identify key patents and potential future biosimilar entrants

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

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

These patents were extracted from company disclosures

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Number	Approval Date	Patent No.	Assignee	Estimated Patent Expiration	Status	Orphan	Source
Halozyme Therap	HYLENEX RECOMBINANT	hyaluronidase recombinant human	INJECTABLE;INJECTION	021859	001	2005-12-02	Start Trial	Halozyme, Inc. (San Diego, CA)	2039-09-22	RX		company
Halozyme Therap	HYLENEX RECOMBINANT	hyaluronidase recombinant human	INJECTABLE;INJECTION	021859	001	2005-12-02	Start Trial	Halozyme, Inc. (San Diego, CA)	2023-03-05	RX		company
Halozyme Therap	HYLENEX RECOMBINANT	hyaluronidase recombinant human	INJECTABLE;INJECTION	021859	001	2005-12-02	Start Trial	Halozyme, Inc. (San Diego, CA)	2023-03-05	RX		company
Halozyme Therap	HYLENEX RECOMBINANT	hyaluronidase recombinant human	INJECTABLE;INJECTION	021859	001	2005-12-02	Start Trial	Halozyme, Inc. (San Diego, CA)	2023-03-05	RX		company
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Number	>Approval Date	>Patent No.	>Assignee	>Estimated Patent Expiration	>Status	>Orphan	>Source

These patents were identified by searching patent claims

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Number	Approval Date	Patent No.	Assignee	Estimated Patent Expiration	Status	Orphan	Source
Amphastar Pharm	AMPHADASE	hyaluronidase	INJECTABLE;INJECTION	021665	001	2005-11-03	Start Trial	Oxyrane UK Limited (Manchester, GB)	2030-09-29	RX		search
Amphastar Pharm	AMPHADASE	hyaluronidase	INJECTABLE;INJECTION	021665	001	2005-11-03	Start Trial	SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL)	2033-03-11	RX		search
Amphastar Pharm	AMPHADASE	hyaluronidase	INJECTABLE;INJECTION	021665	001	2005-11-03	Start Trial	Halozyme, Inc. (San Diego, CA)	2023-03-05	RX		search
Amphastar Pharm	AMPHADASE	hyaluronidase	INJECTABLE;INJECTION	021665	001	2005-11-03	Start Trial	Oxyrane UK Limited (Manchester, GB) VIB vzw (Ghent, BE) Universiteit Gent (Ghent, BE)	2027-04-03	RX		search
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Number	>Approval Date	>Patent No.	>Assignee	>Estimated Patent Expiration	>Status	>Orphan	>Source

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Country	Patent Number	Estimated Expiration
European Patent Office	1641916	Start Trial
World Intellectual Property Organization (WIPO)	2015123477	Start Trial
Mexico	2008015166	Start Trial
European Patent Office	1790665	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90041-0	Sweden	Start Trial	MARKNADSGODKAENNANDE NR.: EU/1/13/819/001, 2013-03-15, MIKROPLASMIN
2017000066197	Italy	Start Trial	PRODUCT NAME: SALE SODICO DI ACIDO DESOSSICOLICO(BELKYRA); AUTHORISATION NUMBER(S) AND DATE(S): 044896013, 20161219;IS/1/16/071/01, 20160729
2017006	Lithuania	Start Trial	PRODUCT NAME: DEZOKSICHOLIO RUGSTIES NATRIO DRUSKA; REGISTRATION NO/DATE: LT/1/16/3960/001 20160909
C/GB13/057	United Kingdom	Start Trial	PRODUCT NAME: OCRIPLASMIN; REGISTERED: UK EU/1/13/819/001 20130315
>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description