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.
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 |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for DEFITELIO
Generic Entry 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:
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 |
Anatomical Therapeutic Chemical (ATC) Classes for DEFITELIO
US Patents and Regulatory Information for DEFITELIO
DEFITELIO is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DEFITELIO is See Plans and Pricing.
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Euglobulin-based method for determining the biological activity of defibrotide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Jazz Pharms Inc | DEFITELIO | defibrotide sodium | SOLUTION;INTRAVENOUS | 208114-001 | Mar 30, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Jazz Pharms Inc | DEFITELIO | defibrotide sodium | SOLUTION;INTRAVENOUS | 208114-001 | Mar 30, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 |
---|---|---|---|
South Korea | 102038357 | See Plans and Pricing | |
South Korea | 20180098420 | 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) | See Plans and Pricing |
India | 10584DEN2014 | See Plans and Pricing | |
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) | See Plans and Pricing |
Israel | 236132 | שיטה מבוססת-יוגלובולין לקביעת הפעילות הביולוגית של דפיברוטיד (Euglobulin-based method for determining the biological activity of defibrotide) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |