Generic Version of DDAVP to Treat Mild Hemophilia A Launches in US

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by Vanessa Pataia |

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Dr. Reddy’s Laboratories announced the U.S. launch of a generic version of DDAVP (desmopressin acetate), used to control bleeding in people with mild hemophilia A.

The generic is available under the name Desmopressin Acetate Injection USP, 4 micrograms/mL, in a carton of 10 single-dose ampules of 1mL each. Prescribing information released by the company can be found here.

Generic medicines are designed to work in the same way and provide the same benefits as brand-name versions. They are typically sold after the patent granting marketing exclusivity to the reference product, in this case Ferring Pharmaceuticals‘ DDAVP, has expired.

Generic treatments tend to cost less than brand-name versions, because their developers do not need to repeat the preclinical studies and clinical trials required to demonstrate a medication’s safety and effectiveness for a given indication.

Hemophilia A is caused by mutations in the F8 gene, which provides instructions for producing a blood clotting protein, called factor VIII (FVIII). In people with hemophilia A, the FVIII protein is missing or faulty.

Desmopressin acetate is a lab-made version of vasopressin, a naturally occurring hormone that stimulates the release of FVIII and von Willebrand factor (vWF) from the cells lining the inside of blood vessels. vWF is a protein that carries and stabilizes FVIII in the bloodstream.

The therapy is indicated to prevent bleedings during and after surgical procedures in patients with mild hemophilia A (FVIII coagulant activity levels greater than 5%), but can also be used to stop spontaneous or trauma-induced bleedings in this patient population.

This treatment may also be used for those with von Willebrand’s disease type 1, which is caused by insufficient levels of normal vWF, and patients with diabetes insipidus.

Dr. Reddy’s collaborated with SunGen Pharma to launch the generic version of desmopressin acetate injections in the U.S.

“The launch of Desmopressin Injection demonstrates a strong, growing collaboration with SunGen Pharma. We look forward to future opportunities with this company.” Marc Kikuchi, CEO of North America Generics, Dr. Reddy’s Laboratories, said in a press release.

Added Isaac Liu, PhD, co-CEO of SunGen: “We are pleased to be working with Dr. Reddy’s for this launch. The launch of Desmopressin demonstrates our strong development capabilities. We look forward to collaborating further to bring specialty pharmaceutical drugs to the markets around the world.”

Both companies, Dr. Reddy and SunGen, specialize in the production of generic prescription medications.