Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Boehringer Ingelheim
Queensland Health
Baxter
Healthtrust

Generated: May 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021859

« Back to Dashboard

NDA 021859 describes HYLENEX RECOMBINANT, which is a drug marketed by Halozyme Therap and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the HYLENEX RECOMBINANT profile page.

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.
Summary for 021859
Tradename:HYLENEX RECOMBINANT
Applicant:Halozyme Therap
Ingredient:hyaluronidase recombinant human
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021859
Generic Entry Date for 021859*:
Constraining patent/regulatory exclusivity:
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 NDA: 021859
Suppliers and Packaging for NDA: 021859
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYLENEX RECOMBINANT hyaluronidase recombinant human INJECTABLE;INJECTION 021859 NDA Halozyme, Inc. 18657-117 18657-117-04 4 BOX in 1 CARTON (18657-117-04) > 1 VIAL in 1 BOX (18657-117-02) > 1 mL in 1 VIAL (18657-117-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150 UNITS/ML
Approval Date:Dec 2, 2005TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 23, 2027Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Moodys
US Army
Accenture
McKinsey
Chubb

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.