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Last Updated: June 14, 2024

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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 three 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 22, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DEFITELIO
International Patents:25
US Patents:3
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

See drug prices for DEFITELIO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEFITELIO
Generic Entry Date for DEFITELIO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for DEFITELIO

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

SponsorPhase
Gregory YanikPhase 1
Jazz PharmaceuticalsPhase 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 three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DEFITELIO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DEFITELIO


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Euglobulin-based method for determining the biological activity of defibrotide
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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

When does loss-of-exclusivity occur for DEFITELIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 12383169
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014031934
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 74960
Estimated Expiration: ⤷  Sign Up

China

Patent: 4619857
Estimated Expiration: ⤷  Sign Up

Patent: 0079580
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 64496
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 64496
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 08503
Estimated Expiration: ⤷  Sign Up

India

Patent: 584DEN2014
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6132
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 98821
Estimated Expiration: ⤷  Sign Up

Patent: 15521477
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 2085
Estimated Expiration: ⤷  Sign Up

Patent: 14016114
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 27177
Estimated Expiration: ⤷  Sign Up

Patent: 14149089
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201408481U
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1948243
Estimated Expiration: ⤷  Sign Up

Patent: 2038357
Estimated Expiration: ⤷  Sign Up

Patent: 150044877
Estimated Expiration: ⤷  Sign Up

Patent: 180098420
Estimated Expiration: ⤷  Sign Up

Patent: 190016148
Estimated Expiration: ⤷  Sign Up

Patent: 190112197
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 60969
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Singapore 11201408481U EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE ⤷  Sign Up
China 110079580 ⤷  Sign Up
South Korea 20180098420 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) ⤷  Sign Up
Mexico 352085 MÉTODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLÓGICA DE DEFIBRÓTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2013190582 ⤷  Sign Up
Denmark 2864496 ⤷  Sign Up
Mexico 2014016114 METODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLOGICA DE DEFIBROTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.