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Last Updated: March 29, 2024

Details for Patent: 11,236,328


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Summary for Patent: 11,236,328
Title:Euglobulin-based method for determining the biological activity of defibrotide
Abstract: It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.
Inventor(s): Ignoni; Terenzio (Solbiate, IT), Kumar; Vijay (Casnate, IT), Islam; Khalid (Massagno, IT)
Assignee: GENTIUM S.R.L. (Villa Guardia, IT)
Application Number:17/459,169
Patent Claim Types:
see list of patent claims
Use; Formulation;

Drugs Protected by US Patent 11,236,328

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial 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) ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,236,328

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012383169 ⤷  Try a Trial
Brazil 112014031934 ⤷  Try a Trial
Canada 2874960 ⤷  Try a Trial
China 104619857 ⤷  Try a Trial
China 110079580 ⤷  Try a Trial
Denmark 2864496 ⤷  Try a Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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