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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Federal Trade Commission
Argus Health
Queensland Health
Deloitte
UBS
Accenture
Moodys
Teva

Generated: June 17, 2018

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.

The generic ingredient in HYLENEX RECOMBINANT is hyaluronidase recombinant human. There are six drug master file entries for this compound. One supplier is 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 for HYLENEX RECOMBINANT

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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 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
9,677,061 Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof ➤ Sign Up
8,772,246 Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof ➤ Sign Up
2,015,196,623 ➤ Sign Up
8,202,517 Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for HYLENEX RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0822 Netherlands ➤ Sign Up PRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 - UITVOERINGSBESLUIT C(2014)2048 20140326
0753 Netherlands ➤ Sign Up PRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2015000061 Germany ➤ Sign Up PRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2016000049 Germany ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Chinese Patent Office
Healthtrust
Boehringer Ingelheim
Citi
Covington
Deloitte
Moodys
Federal Trade Commission

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.