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Last Updated: July 18, 2024

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
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.

Recent Clinical Trials for DEFIBROTIDE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, San FranciscoPhase 2
Jazz PharmaceuticalsPhase 2

See all DEFIBROTIDE SODIUM clinical trials

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
Mexico 352085 MÉTODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLÓGICA DE DEFIBRÓTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.) ⤷  Sign Up
India 10584DEN2014 ⤷  Sign Up
China 110079580 用于测定去纤维蛋白多核苷酸的生物活性的基于优球蛋白的方法 (Euglobulin-based method used for measuring biological activity of dcfibrotide) ⤷  Sign Up
Denmark 2864496 ⤷  Sign Up
Russian Federation 2014149089 СПОСОБ ОПРЕДЕЛЕНИЯ БИОЛОГИЧЕСКОЙ АКТИВНОСТИ ДЕФИБРОТИДА, ОСНОВАННЫЙ НА ПРИМЕНЕНИИ ЭУГЛОБУЛИНА ⤷  Sign Up
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 ⤷  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

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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.