➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
McKesson
Mallinckrodt
Merck
Harvard Business School

Last Updated: July 12, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021196


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021196 describes XYREM, which is a drug marketed by Jazz Pharms and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XYREM profile page.

The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium oxybate profile page.
Summary for 021196
Tradename:XYREM
Applicant:Jazz Pharms
Ingredient:sodium oxybate
Patents:14
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021196
Suppliers and Packaging for NDA: 021196
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYREM sodium oxybate SOLUTION;ORAL 021196 NDA Jazz Pharmaceuticals, Inc. 68727-100 68727-100-01 180 mL in 1 BOTTLE, PLASTIC (68727-100-01)
Paragraph IV (Patent) Challenges for 021196
Tradename Dosage Ingredient NDA Submissiondate
XYREM SOLUTION;ORAL sodium oxybate 021196 2010-07-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength500MG/ML
Approval Date:Jul 17, 2002TE:AARLD:Yes
Regulatory Exclusivity Expiration:Oct 26, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
Regulatory Exclusivity Expiration:Oct 26, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 26, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Merck
AstraZeneca
Medtronic
McKesson

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 verification 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.