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Generated: April 26, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021196

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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 eighteen 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
Applicant:Jazz Pharms
Ingredient:sodium oxybate
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)

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, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 26, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Sign UpPatent Expiration:Jan 4, 2021Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

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Harvard Business School
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