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Generated: September 23, 2018

DrugPatentWatch Database Preview

HYLENEX RECOMBINANT Drug Profile

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Which patents cover Hylenex Recombinant, and what generic alternatives are available?

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

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
Generic Entry Opportunity Date for HYLENEX RECOMBINANT
Generic Entry Date for HYLENEX RECOMBINANT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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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Supplementary Protection Certificates for HYLENEX RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00043 Denmark ➤ Sign Up PRODUCT NAME: TRASTUZUMAB OG REKOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: C(20135603) /EU/1/00/145/002 20130826
0753 Netherlands ➤ Sign Up PRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
0822 Netherlands ➤ Sign Up PRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 - UITVOERINGSBESLUIT C(2014)2048 20140326
2016 00031 Denmark ➤ Sign Up PRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: EU/1/98/067 20140326
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Baxter
AstraZeneca
UBS
Mallinckrodt
Johnson and Johnson
Colorcon
Dow
Moodys

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