Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Dow
Baxter
Colorcon
McKinsey

Last Updated: November 20, 2019

DrugPatentWatch Database Preview

HYLENEX RECOMBINANT Drug Profile

See Plans and Pricing

« Back to Dashboard

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-eight 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. 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
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.

Recent Clinical Trials for HYLENEX RECOMBINANT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 2
New York University School of MedicinePhase 2
Steve Yoelin M.D. Medical Associates, Inc.Phase 1

See all HYLENEX RECOMBINANT clinical trials

Recent Litigation for HYLENEX RECOMBINANT

Identify potential future generic entrants

District Court Litigation
Case NameDate
Halozyme, Inc. v. Lee2016-12-19

See all HYLENEX RECOMBINANT litigation

Pharmacology for HYLENEX RECOMBINANT
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   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for HYLENEX RECOMBINANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2163643 300753 Netherlands   Start Trial PRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826
2163643 92780 Luxembourg   Start Trial PRODUCT NAME: TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20130826
2405015 CA 2016 00031 Denmark   Start Trial PRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; REG. NO/DATE: EU/1/98/067 20140326
2405015 300822 Netherlands   Start Trial PRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 - UITVOERINGSBESLUIT C(2014)2048 20140326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
McKesson
Baxter
McKinsey
Harvard Business School
Moodys

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.