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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.
The United States Patent and Trademark Office (USPTO) granted patent approval to Eagle Pharmaceuticals’ product related to the rapid infusion of bendamustine hydrochloride, which includes the administration of the product in a 50 mL bag within 10 minutes. The patent issuance precedes the approval of the medication by FDA; the Prescription Drug User Fee Act goal date for the medication itself is Dec. 13, 2015.
The medication is meant for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma during or following six months of treatment with rituximab. It has received an Orphan drug designation for both indications from FDA, which, if approved, is associated with seven years of exclusivity. The patent for the drug delivery method, however, will last until March 2033.
Teva Pharmaceuticals has an exclusive license agreement for the rapid infusion product and will be responsible for all commercial activities for the product in the United States. Bendamustine is the active ingredient of the commercial product Treanda, a lyophilized powder for reconstitution, which is distributed by Teva. According to patent documents, the product is typically frozen. Once reconstituted, the current intravenous infusion is given during a period of 30 or 60 minutes, depending on the product concentration. At room temperature, the product must be administered within three hours post reconstitution due to limited chemical stability in aqueous solutions. As a result, the patent application asserts that the current product has a short period of stability, and “degradation of the drug occurs from the time of reconstitution until the entire large volume infusion has been completely administered.” The patent application also says that the new, non-aqueous formulations of bendamustine “offer better chemical stability than Treanda when admixed into smaller volumes.”
In addition to being more chemically stable, the rapid infusion product from Eagle will lead to shorter infusion times and lower infusion volumes, leading to fewer instances of weight gain and edema in patients.