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DEFITELIO Drug 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.
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.
Summary for DEFITELIO
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for DEFITELIO |
| DailyMed Link: | DEFITELIO at DailyMed |
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 |
|---|---|
| Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Phase 2 |
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Start Trial | ||||
| Jazz Pharms Inc | DEFITELIO | defibrotide sodium | SOLUTION;INTRAVENOUS | 208114-001 | Mar 30, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
