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Last Updated: July 18, 2024

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. There are three patents protecting this drug. 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:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208114
Generic Entry Date for 208114*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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
Patent:⤷  Sign UpPatent Expiration:Jun 22, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 22, 2032Product Flag?Substance Flag?Delist Request?
Patented Use: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)
Patent:⤷  Sign UpPatent Expiration:Jun 22, 2032Product Flag?YSubstance Flag?Delist Request?

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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.