~ Buy the DEFITELIO (defibrotide sodium) Drug Profile, 2024 PDF Report in the Report Store ~

DEFITELIO Drug Patent Profile

✉ Email this page to a colleague

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

< Available with Subscription >

Try a Trial

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

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

Generic Entry Date for DEFITELIO^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
Gregory Yanik	Phase 1
Jazz Pharmaceuticals	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 three US patents.

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

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ 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)

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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	Y			⤷ 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

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: ⤷ Try a Trial

Brazil

Patent: 2014031934
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 74960
Estimated Expiration: ⤷ Try a Trial

China

Patent: 4619857
Estimated Expiration: ⤷ Try a Trial

Patent: 0079580
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 64496
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 64496
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 08503
Estimated Expiration: ⤷ Try a Trial

India

Patent: 584DEN2014
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 6132
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 98821
Estimated Expiration: ⤷ Try a Trial

Patent: 15521477
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 2085
Estimated Expiration: ⤷ Try a Trial

Patent: 14016114
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 27177
Estimated Expiration: ⤷ Try a Trial

Patent: 14149089
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 201408481U
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1948243
Estimated Expiration: ⤷ Try a Trial

Patent: 2038357
Estimated Expiration: ⤷ Try a Trial

Patent: 150044877
Estimated Expiration: ⤷ Try a Trial

Patent: 180098420
Estimated Expiration: ⤷ Try a Trial

Patent: 190016148
Estimated Expiration: ⤷ Try a Trial

Patent: 190112197
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 60969
Estimated Expiration: ⤷ Try a Trial

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.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Singapore	11201408481U	EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE	⤷ Try a Trial
Japan	6198821		⤷ Try a Trial
Israel	236132	שיטה מבוססת-יוגלובולין לקביעת הפעילות הביולוגית של דפיברוטיד (Euglobulin-based method for determining the biological activity of defibrotide)	⤷ Try a Trial
South Korea	102038357		⤷ Try a Trial
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)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration