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Serving leading biopharmaceutical companies globally:

Express Scripts
UBS
Dow
Colorcon
Cipla
Julphar
McKesson
Johnson and Johnson
Argus Health
QuintilesIMS

Generated: January 19, 2018

DrugPatentWatch Database Preview

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.

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

US Patents and Regulatory Information for hyaluronidase recombinant human

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;INJECTION 021859-001 Dec 2, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,105,586 Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases ➤ Subscribe
8,580,252 Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases ➤ Subscribe
2,015,196,623 ➤ Subscribe
8,431,124 Methods for treating a disease characterized by an excess of hyaluronan by administering a soluble hyaluronidase glycoprotein (sHASEGP) ➤ Subscribe
9,562,223 Methods for reducing intraocular pressure by administering a soluble hyaluronidase glycoprotein (sHASEGP) ➤ Subscribe
9,211,315 Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases ➤ Subscribe
8,765,685 Methods for treating edema by administering a Soluble Hyaluronidase Glycoprotein (sHASEGP) ➤ Subscribe
8,772,246 Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof ➤ Subscribe
9,677,061 Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof ➤ Subscribe
7,829,081 Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for hyaluronidase recombinant human

Supplementary Protection Certificates for hyaluronidase recombinant human

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016022 Lithuania ➤ Subscribe PRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321
2015 00043 Denmark ➤ Subscribe PRODUCT NAME: TRASTUZUMAB OG REKOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: C(20135603) /EU/1/00/145/002 20130826
0822 Netherlands ➤ Subscribe PRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 - UITVOERINGSBESLUIT C(2014)2048 20140326
0753 Netherlands ➤ Subscribe PRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2016 00031 Denmark ➤ Subscribe PRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: EU/1/98/067 20140326
2015000061 Germany ➤ Subscribe PRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2016000049 Germany ➤ Subscribe 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
2015031 Lithuania ➤ Subscribe PRODUCT NAME: TRASTUZUMABAS IR REKOMBINANTINE ZMOGAUS HIALURONIDAZE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2016 00031 Denmark ➤ Subscribe PRODUCT 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
780 Luxembourg ➤ Subscribe PRODUCT NAME: TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20130826
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Julphar
Mallinckrodt
Teva
Cantor Fitzgerald
McKinsey
McKesson
Cipla
UBS
QuintilesIMS

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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