DEFITELIO Drug Patent Profile

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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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

See drug prices for DEFITELIO

DrugPatentWatch^® Estimated Generic Entry Opportunity 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:

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
Jazz Pharmaceuticals	Phase 1
Gregory Yanik	Phase 1
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	Phase 2

See all DEFITELIO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DEFITELIO

B01AX	Other antithrombotic agents
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for DEFITELIO

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

This potential generic entry date is based on 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)..

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

FDA Regulatory Exclusivity protecting 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
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes			Y
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes

International Patents for DEFITELIO

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

Country	Patent Number	Title	Estimated Expiration
South Korea	102038357
South Korea	20180098420	디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
India	10584DEN2014
China	110079580	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)
Israel	236132	שיטה מבוססת-יוגלובולין לקביעת הפעילות הביולוגית של דפיברוטיד (Euglobulin-based method for determining the biological activity of defibrotide)