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.
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 |
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.
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)
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: ⤷ 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 | ⤷ 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
See the table below for patents covering DEFITELIO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2014149089 | СПОСОБ ОПРЕДЕЛЕНИЯ БИОЛОГИЧЕСКОЙ АКТИВНОСТИ ДЕФИБРОТИДА, ОСНОВАННЫЙ НА ПРИМЕНЕНИИ ЭУГЛОБУЛИНА | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| 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 | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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