defitelio Drug Patent Profile
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Which patents cover Defitelio, 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
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for defitelio
*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 |
Anatomical Therapeutic Chemical (ATC) Classes for defitelio
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)
| 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 |
|---|---|---|---|
| Israel | 236132 | שיטה מבוססת-יוגלובולין לקביעת הפעילות הביולוגית של דפיברוטיד (Euglobulin-based method for determining the biological activity of defibrotide) | ⤷ Sign Up |
| Canada | 2874960 | ⤷ Sign Up | |
| European Patent Office | 2864496 | PROCÉDÉ À BASE D'EUGLOBULINE POUR LA DÉTERMINATION DE L'ACTIVITÉ BIOLOGIQUE DE DÉFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) | ⤷ Sign Up |
| Canada | 2874960 | PROCEDE A BASE D'EUGLOBULINE POUR LA DETERMINATION DE L'ACTIVITE BIOLOGIQUE DE DEFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) | ⤷ Sign Up |
| Australia | 2012383169 | Euglobulin-based method for determining the biological activity of defibrotide | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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