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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Boehringer Ingelheim
Cerilliant
Merck
Express Scripts
Novartis
Julphar
Dow
QuintilesIMS

Generated: November 20, 2017

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Hyaluronidase recombinant human - Generic Drug Details

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What are the generic drug sources for hyaluronidase recombinant human and what is the scope of hyaluronidase recombinant human freedom to operate?

Hyaluronidase recombinant human
is the generic ingredient in one branded drug marketed by Halozyme Therap and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Hyaluronidase recombinant human has ninety-seven patent family members in twenty-five countries and eleven supplementary protection certificates in five countries.

There are six drug master file entries for hyaluronidase recombinant human. Two suppliers are listed for this compound.

Summary for hyaluronidase recombinant human

Pharmacology for hyaluronidase recombinant human

Ingredient-typeGlycoside Hydrolases
Drug ClassEndoglycosidase
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halozyme Therap
HYLENEX RECOMBINANT
hyaluronidase recombinant human
INJECTABLE;INJECTION021859-001Dec 2, 2005RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: hyaluronidase recombinant human

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
9,677,061Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof► Subscribe
8,772,246Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof► Subscribe
8,765,685Methods for treating edema by administering a Soluble Hyaluronidase Glycoprotein (sHASEGP)► Subscribe
2,015,196,623► Subscribe
7,871,607Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases► Subscribe
8,105,586Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases► Subscribe
8,431,124Methods for treating a disease characterized by an excess of hyaluronan by administering a soluble hyaluronidase glycoprotein (sHASEGP)► Subscribe
8,257,699Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases► Subscribe
8,431,380Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof► Subscribe
9,677,062Hyaluronidase and factor VIII compositions► 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 Ingredient: hyaluronidase recombinant human

Country Document Number Estimated Expiration
Cyprus1116110► Subscribe
Cyprus1117104► Subscribe
Hong Kong1138883► Subscribe
MexicoPA05009429► Subscribe
Spain2335005► Subscribe
Cyprus1109750► Subscribe
Spain2532399► Subscribe
South Korea101363658► Subscribe
World Intellectual Property Organization (WIPO)2004078140► Subscribe
Eurasian Patent Organization009383► 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: HYALURONIDASE RECOMBINANT HUMAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0753Netherlands► SubscribePRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
780Luxembourg► SubscribePRODUCT NAME: TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20130826
2016 00031Denmark► SubscribePRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: EU/1/98/067 20140326
0822Netherlands► SubscribePRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 - UITVOERINGSBESLUIT C(2014)2048 20140326
2015 00043Denmark► SubscribePRODUCT NAME: TRASTUZUMAB OG REKOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: C(20135603) /EU/1/00/145/002 20130826
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
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
138Luxembourg► SubscribePRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20140326
2016022Lithuania► SubscribePRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321
2015000061Germany► SubscribePRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Healthtrust
UBS
Medtronic
AstraZeneca
Dow
Accenture
QuintilesIMS
Harvard Business School

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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