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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:	4
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DEFITELIO

Generic Entry Date for DEFITELIO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208114 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

Sponsor	Phase
New York Medical College	Phase 2
Gregory Yanik	Phase 1
Jazz Pharmaceuticals	Phase 1

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

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Glossary

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

Brazil

Patent: 2014031934
Patent: método com base em euglobulina para determinar a atividade biológica de defibrotide
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 74960
Patent: PROCEDE A BASE D'EUGLOBULINE POUR LA DETERMINATION DE L'ACTIVITE BIOLOGIQUE DE DEFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷ Sign Up

China

Patent: 4619857
Patent: Euglobulin-based method for determining the biological activity of defibrotide
Estimated Expiration: ⤷ Sign Up

Patent: 0079580
Patent: 用于测定去纤维蛋白多核苷酸的生物活性的基于优球蛋白的方法 (Euglobulin-based method used for measuring biological activity of dcfibrotide)
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 64496
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 64496
Patent: PROCÉDÉ À BASE D'EUGLOBULINE POUR LA DÉTERMINATION DE L'ACTIVITÉ BIOLOGIQUE DE DÉFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 08503
Patent: 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)
Estimated Expiration: ⤷ Sign Up

India

Patent: 584DEN2014
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 6132
Patent: שיטה מבוססת-יוגלובולין לקביעת הפעילות הביולוגית של דפיברוטיד (Euglobulin-based method for determining the biological activity of defibrotide)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 98821
Estimated Expiration: ⤷ Sign Up

Patent: 15521477
Patent: 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
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 2085
Patent: MÉTODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLÓGICA DE DEFIBRÓTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.)
Estimated Expiration: ⤷ Sign Up

Patent: 14016114
Patent: METODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLOGICA DE DEFIBROTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.)
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 27177
Patent: СПОСОБ ОПРЕДЕЛЕНИЯ БИОЛОГИЧЕСКОЙ АКТИВНОСТИ ДЕФИБРОТИДА, ОСНОВАННЫЙ НА ПРИМЕНЕНИИ ЭУГЛОБУЛИНА (METHOD FOR DEFIBROTIDE BIOLOGICAL ACTIVITY DETERMINATION, BASED ON EUGLOBULIN APPLICATION)
Estimated Expiration: ⤷ Sign Up

Patent: 14149089
Patent: СПОСОБ ОПРЕДЕЛЕНИЯ БИОЛОГИЧЕСКОЙ АКТИВНОСТИ ДЕФИБРОТИДА, ОСНОВАННЫЙ НА ПРИМЕНЕНИИ ЭУГЛОБУЛИНА
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201408481U
Patent: EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1948243
Estimated Expiration: ⤷ Sign Up

Patent: 2038357
Estimated Expiration: ⤷ Sign Up

Patent: 150044877
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷ Sign Up

Patent: 180098420
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷ Sign Up

Patent: 190016148
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷ Sign Up

Patent: 190112197
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
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.

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Country	Patent Number	Title	Estimated Expiration
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	⤷ Sign Up
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)	⤷ Sign Up
South Korea	102038357		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration