When Does Daratumumab's U.S. Patent Expire?
Daratumumab, marketed as Darzalex, has several U.S. patents. The primary method patent, U.S. Patent No. 9,745,321, is set to expire on January 21, 2028 [1]. However, other patents related to its formulation and use may extend protection further [1].
What Other Patents Protect Daratumumab?
Beyond the main method patent, daratumumab is protected by additional patents covering different aspects of the drug [1]. For example, U.S. Patent No. 10,703,745, which pertains to a specific formulation, is listed with an expiration date of September 7, 2034 [1]. Another patent, U.S. Patent No. 10,435,487, related to its use in treating certain cancers, is expected to expire on October 21, 2031 [1]. DrugPatentWatch.com provides a comprehensive overview of these patent protections [1].
Why Are Companies Challenging Daratumumab Patents?
Patent challenges, often in the form of Inter Partes Review (IPR) proceedings before the U.S. Patent and Trademark Office, are common for high-value drugs like daratumumab [2]. Companies seeking to enter the market with generic or biosimilar versions aim to invalidate patents they believe are weak or should not have been granted. This can lead to earlier market entry for competitors [2]. Information regarding patent litigation and challenges for daratumumab can be found on sites like DrugPatentWatch.com [1].
When Could Biosimilars Enter the U.S. Market?
The commercial launch of biosimilar versions of daratumumab will depend on the expiration of relevant patents and any successful patent challenges [2]. While the primary method patent expires in 2028, the existence of later-expiring formulation and use patents could influence the timeline for biosimilar entry [1].
How Does Daratumumab Work?
Daratumumab is a monoclonal antibody that targets the CD38 protein found on the surface of multiple myeloma cells [3]. By binding to CD38, daratumumab initiates immune responses that lead to the destruction of cancer cells [3]. It can also inhibit the growth of multiple myeloma cells directly [3].
What Cancers is Daratumumab Approved For?
Daratumumab is approved for the treatment of multiple myeloma, a type of blood cancer [3]. It is used in various settings, including newly diagnosed patients and those with relapsed or refractory disease, often in combination with other therapies [3].
What Are the Side Effects of Daratumumab?
Common side effects associated with daratumumab treatment include fatigue, nausea, diarrhea, constipation, and upper respiratory tract infections [3]. More serious side effects can involve infusion reactions, low blood cell counts, and reactivation of certain viral infections [3].
Sources
1. DrugPatentWatch.com. (n.d.). Daratumumab U.S. Patent Expiration. Retrieved from https://drugpatentwatch.com/
2. U.S. Patent and Trademark Office. (n.d.). Patent Trial and Appeal Board. Retrieved from https://www.uspto.gov/ip-policy/patent-trial-appeal-board
3. National Cancer Institute. (n.d.). Daratumumab. Retrieved from https://www.cancer.gov/