DEFIBROTIDE SODIUM - Generic Drug Details
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What are the generic drug sources for defibrotide sodium and what is the scope of freedom to operate?
Defibrotide sodium
is the generic ingredient in one branded drug marketed by Jazz Pharms Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Defibrotide sodium has twenty-five patent family members in sixteen countries.
One supplier is listed for this compound.
Summary for DEFIBROTIDE SODIUM
| International Patents: | 25 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 1 |
| What excipients (inactive ingredients) are in DEFIBROTIDE SODIUM? | DEFIBROTIDE SODIUM excipients list |
| DailyMed Link: | DEFIBROTIDE SODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEFIBROTIDE SODIUM
*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 DEFIBROTIDE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Phase 2 |
| Jazz Pharmaceuticals | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for DEFIBROTIDE SODIUM
US Patents and Regulatory Information for DEFIBROTIDE SODIUM
| 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 | 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 | |||
| Jazz Pharms Inc | DEFITELIO | defibrotide sodium | SOLUTION;INTRAVENOUS | 208114-001 | Mar 30, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 DEFIBROTIDE SODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 2864496 | ⤷ Sign Up | |
| Mexico | 2014016114 | METODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLOGICA DE DEFIBROTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.) | ⤷ Sign Up |
| South Korea | 20190112197 | 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
