Daratumumab hyaluronidase, marketed as Darzalex Faspro, is a subcutaneous formulation of daratumumab [1]. It combines daratumumab with recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that facilitates the dispersion and absorption of the drug through the subcutaneous tissue [2]. This formulation allows for administration under the skin, reducing infusion time and potentially improving patient convenience compared to the intravenous formulation [1, 2].
When is the Daratumumab Hyaluronidase Patent Expected to Expire?
The patent landscape for drug formulations can be complex, involving multiple patents covering the active pharmaceutical ingredient, specific formulations, manufacturing processes, and methods of use [3]. Information regarding the precise expiry dates of all patents covering the daratumumab hyaluronidase formulation is typically detailed and may vary by region [4]. DrugPatentWatch.com provides resources for tracking patent expiries and exclusivity periods for various drugs [5].
How Does Daratumumab Hyaluronidase Work?
Daratumumab is a monoclonal antibody that targets the CD38 protein found on the surface of malignant plasma cells [1]. By binding to CD38, daratumumab triggers multiple immune system mechanisms to kill cancer cells, including complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and direct apoptosis [2]. The addition of hyaluronidase PH20 in the subcutaneous formulation enhances the drug's absorption by temporarily breaking down hyaluronic acid, a component of the extracellular matrix in the dermis [2].
What are the Benefits of the Subcutaneous Formulation?
The subcutaneous formulation of daratumumab, Darzalex Faspro, offers several advantages over the intravenous version. It significantly reduces administration time from hours to minutes, improving patient convenience and potentially freeing up healthcare resources [1, 2]. Studies have shown comparable efficacy and safety profiles between the subcutaneous and intravenous formulations [1, 2].
What Are Competitors in the CD38 Inhibitor Space?
Besides daratumumab, other CD38 inhibitors are in development or on the market for multiple myeloma [6]. These include isatuximab and potential biosimilars of daratumumab itself. The competitive landscape is dynamic, with ongoing research into novel targets and therapeutic approaches for multiple myeloma [6].
Where Can I Find More Information on Daratumumab Patents?
Detailed information on patents, including their status, expiry dates, and any associated litigation, can be found through specialized patent databases and resources like DrugPatentWatch.com [5]. These platforms track intellectual property rights for pharmaceutical products, which is crucial for understanding market exclusivity and the potential for generic or biosimilar entry [5].