Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
McKesson
Harvard Business School
Cerilliant
Baxter
Mallinckrodt
Citi
Accenture
US Department of Justice

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208114

« Back to Dashboard

NDA 208114 describes DEFITELIO, which is a drug marketed by Jazz Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DEFITELIO profile page.

The generic ingredient in DEFITELIO is defibrotide sodium. One supplier is listed for this compound. Additional details are available on the defibrotide sodium profile page.
Summary for 208114
Tradename:DEFITELIO
Applicant:Jazz Pharms Inc
Ingredient:defibrotide sodium
Patents:0
Suppliers and Packaging for NDA: 208114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFITELIO defibrotide sodium SOLUTION;IV (INFUSION) 208114 NDA Jazz Pharmaceuticals, Inc. 68727-800 N 68727-800-02
DEFITELIO defibrotide sodium SOLUTION;IV (INFUSION) 208114 NDA Jazz Pharmaceuticals, Inc. 68727-800 N 68727-800-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength200MG/2.5ML (80MG/ML)
Approval Date:Mar 30, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 30, 2023
Regulatory Exclusivity Use:FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH HEPATIC VENO-OCCLUSIVE DISEASE (VOD), ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), WITH RENAL OR PULMONARY DYSFUNCTION FOLLOWING HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT).
Regulatory Exclusivity Expiration:Mar 30, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
US Army
Baxter
Citi
UBS
Queensland Health
Julphar
Chinese Patent Office
Express Scripts

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.