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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Argus Health
Merck
Mallinckrodt
Novartis
Teva
McKesson
Healthtrust
Accenture

Generated: December 16, 2017

DrugPatentWatch Database Preview

HYLENEX RECOMBINANT Drug Profile

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When do Hylenex Recombinant patents expire, and when can generic versions of Hylenex Recombinant launch?

Hylenex Recombinant is a drug marketed by Halozyme Therap and is included in one NDA. There is one patent protecting this drug.

This drug has ninety-seven patent family members in twenty-five countries and eleven supplementary protection certificates in five countries.

The generic ingredient in HYLENEX RECOMBINANT is hyaluronidase recombinant human. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hyaluronidase recombinant human profile page.
Drug patent expirations by year for HYLENEX RECOMBINANT

Pharmacology for HYLENEX RECOMBINANT

Ingredient-typeGlycoside Hydrolases
Drug ClassEndoglycosidase

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halozyme TherapHYLENEX RECOMBINANThyaluronidase recombinant humanINJECTABLE;INJECTION021859-001Dec 2, 2005RXYesYes► Subscribe► SubscribeYY► Subscribe
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Non-Orange Book Patents for Tradename: HYLENEX RECOMBINANT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,677,062Hyaluronidase and factor VIII compositions► Subscribe
8,257,699Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases► Subscribe
9,562,223Methods for reducing intraocular pressure by administering a soluble hyaluronidase glycoprotein (sHASEGP)► Subscribe
8,765,685Methods for treating edema by administering a Soluble Hyaluronidase Glycoprotein (sHASEGP)► Subscribe
2,015,196,623► Subscribe
8,431,124Methods for treating a disease characterized by an excess of hyaluronan by administering a soluble hyaluronidase glycoprotein (sHASEGP)► Subscribe
8,772,246Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof► Subscribe
8,431,380Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof► Subscribe
8,202,517Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof► Subscribe
7,871,607Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: HYLENEX RECOMBINANT

Country Document Number Estimated Expiration
Australia2013202475► Subscribe
Poland2405015► Subscribe
Australia2009245838► Subscribe
European Patent Office1603541► Subscribe
BrazilPI0408116► Subscribe
Hong Kong1138883► Subscribe
Japan5654510► Subscribe
Japan5538770► Subscribe
Germany602004024041► Subscribe
Spain2526536► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: HYLENEX RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00031Denmark► SubscribePRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: EU/1/98/067 20140326
2016 00031Denmark► SubscribePRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; NAT. REG. NO/DATE: EU/1/98/067/003-004 20140326; FIRST REG. NO/DATE: EU EU/1/98/067 20140326
138Luxembourg► SubscribePRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20140326
0822Netherlands► SubscribePRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 - UITVOERINGSBESLUIT C(2014)2048 20140326
2015000061Germany► SubscribePRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
0753Netherlands► SubscribePRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2015 00043Denmark► SubscribePRODUCT NAME: TRASTUZUMAB OG REKOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: C(20135603) /EU/1/00/145/002 20130826
2016000049Germany► SubscribePRODUCT 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
780Luxembourg► SubscribePRODUCT NAME: TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20130826
2015031Lithuania► SubscribePRODUCT NAME: TRASTUZUMABAS IR REKOMBINANTINE ZMOGAUS HIALURONIDAZE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson
McKinsey
Express Scripts
QuintilesIMS
AstraZeneca
Medtronic
Argus Health
Boehringer Ingelheim
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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