Posted 07 September 2014 - 01:01 AM
East Hanover, NJ, May 14, 2014 -- Novartis Pharmaceuticals Corporation has settled its litigation with a subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of Gleevec®(imatinib mesylate), which expire in 2019 (including pediatric exclusivity). The basic compound patent for Gleevec expires in the U.S. on July 4, 2015.
As a result of the settlement, Novartis will permit Sun Pharma's subsidiary to market a generic version of Gleevec in the United States on February 1, 2016. The terms of the settlement agreement are otherwise confidential. Sun Pharma's subsidiary has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of imatinib mesylate.
PS> had my annual appointment my CML doctor this past week ... she asked if I had any interest in attempting to stop taking Gleevec (on Gleevec for 4 and 1/2 years)... thought she was going to suggest my taking one of the newer drugs, but it turns out that UCSF is conducting a study on the viability of patients, who have been pcru for a prolonged period, stopping oral chemo.
I don't have that many more years ahead of me and would hate to do anything that might upset the apple cart in the interim, so I said no.
For the benefit of yourself and others please add your CML history into your Signature
02/2010 Gleevec 400mg
2011 Two weakly positives, PCRU, weakly positive
2012 PCRU, PCRU, PCRU, PCRU
2013 PCRU, PCRU, PCRU, weakly positive
2014 PCRU, PCRU, PCRU, PCRU (12/07 began dose reduction w/each continuing PCRU)
2015 300, 250, 200, 150
2016 100, 50/100, 100, 10/17 TFR
2017 01/17 TFR, 04/18 TFR, 07/18 TFR 0.0012, 08/29 TFR 0.001, 10/17 TFR 0.000
2018 01/16 TFR PCR result pending... next quarterly PCR 04/17
At the earliest opportunity, and whenever possible, lower your TKI dosage; TKIs are toxic drugs and the less we take longterm the better off we are going to be ... this is especially true for older adults.
In hindsight I should have started my dosage reduction two years earlier; it might have helped minimize some of the longterm cumulative toxic effects of TKIs that I am beset with.
longterm side-effects Peripheral Artery Disease - legs (it's a bitch); continuing shoulder problems, right elbow inflammation. GFR and creatinine vastly improved after stopping Gleevec.
Cumulative Gleevec dosage estimated at 830 grams
Taking Gleevec 400mg an hour after my largest meal of the day helped eliminate the nausea that Gleevec is notorious for.
Trey's CML Blog - Stopping - The Odds - Stop Studies - Discussion Forum Cessation Study
Big PhRMA - Medicare Status - Social Security Status - Deficit/Debt