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Last Updated: November 16, 2019

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DEFITELIO Drug Profile

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When do Defitelio patents expire, and when can generic versions of Defitelio launch?

Defitelio is a drug marketed by Jazz Pharms Inc and is included in one NDA.

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 DEFITELIO
Drug patent expirations by year for DEFITELIO
Drug Prices for DEFITELIO

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Generic Entry Opportunity Date for DEFITELIO
Generic Entry Date for DEFITELIO*:
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).
NDA:
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.

US Patents and Regulatory Information for DEFITELIO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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