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Last Updated: June 3, 2023

DEFITELIO Drug Patent Profile


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When do Defitelio patents expire, and what generic alternatives are available?

Defitelio is a drug marketed by Jazz Pharms Inc and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-five patent family members in sixteen countries.

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.

DrugPatentWatch® Generic Entry Outlook for Defitelio

Defitelio was eligible for patent challenges on March 30, 2020.

Indicators of Generic Entry

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Summary for DEFITELIO
International Patents:25
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 3
Drug Prices: Drug price information for DEFITELIO
What excipients (inactive ingredients) are in DEFITELIO?DEFITELIO excipients list
DailyMed Link:DEFITELIO at DailyMed
Drug patent expirations by year for DEFITELIO
Drug Prices for DEFITELIO

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Recent Clinical Trials for DEFITELIO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jazz PharmaceuticalsPhase 1
Gregory YanikPhase 1
Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaPhase 2

See all DEFITELIO clinical trials

US Patents and Regulatory Information for DEFITELIO

DEFITELIO is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting DEFITELIO


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Euglobulin-based method for determining the biological activity of defibrotide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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)

FDA Regulatory Exclusivity protecting DEFITELIO

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).
Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for DEFITELIO

See the table below for patents covering DEFITELIO around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2014149089 СПОСОБ ОПРЕДЕЛЕНИЯ БИОЛОГИЧЕСКОЙ АКТИВНОСТИ ДЕФИБРОТИДА, ОСНОВАННЫЙ НА ПРИМЕНЕНИИ ЭУГЛОБУЛИНА ⤷  Try a Trial
European Patent Office 2864496 PROCÉDÉ À BASE D'EUGLOBULINE POUR LA DÉTERMINATION DE L'ACTIVITÉ BIOLOGIQUE DE DÉFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) ⤷  Try a Trial
Japan 2015521477 デフィブロチドの生物学的活性を決定する為の、ユーグロブリンに基づく方法 ⤷  Try a Trial
Hong Kong 1208503 用於測定去纖維蛋白多核苷酸的生物活性的基於優球蛋白的方法 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Baxter

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.