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Generated: December 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208114

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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
Generic Entry Opportunity Date for 208114
Generic Entry Date for 208114*:
Constraining patent/regulatory exclusivity:
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).
Dosage:
SOLUTION;IV (INFUSION)

*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.

Suppliers and Packaging for NDA: 208114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114 NDA Jazz Pharmaceuticals, Inc. 68727-800 68727-800-01 2.5 mL in 1 VIAL (68727-800-01)
DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114 NDA Jazz Pharmaceuticals, Inc. 68727-800 68727-800-02 25 mL in 1 CARTON (68727-800-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/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

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