Defibrotide sodium - Generic Drug Details
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What are the generic drug sources for defibrotide sodium and what is the scope of patent protection?
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 |
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
Generic Entry Date for defibrotide sodium*:
Constraining patent/regulatory exclusivity:
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.
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 | ⤷ 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 | 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 defibrotide sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 352085 | MÉTODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLÓGICA DE DEFIBRÓTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.) | ⤷ Try a Trial |
South Korea | 20180098420 | 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) | ⤷ Try a Trial |
South Korea | 20190112197 | 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) | ⤷ Try a Trial |
India | 10584DEN2014 | ⤷ Try a Trial | |
South Korea | 101948243 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |