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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Mallinckrodt
Merck
Medtronic
Teva
Healthtrust
Fuji
Julphar
Accenture

Generated: December 12, 2017

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 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:1
Applicant:1
Ingredient:1
Patents:18
Therapeutic Class:Central Nervous System Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength500MG/ML
Approval Date:Jul 17, 2002TE:AARLD:Yes
Patent:► SubscribePatent Expiration:Jul 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jul 4, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jun 16, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
Cipla
Baxter
McKinsey
Julphar
Daiichi Sankyo

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