What is the patent status of etomidate?
Etomidate, a short-acting intravenous anesthetic agent, has a complex patent landscape. Initially developed by Janssen Pharmaceutica, etomidate was patented in 1977 in the United States (US Patent 4,011,849).
When does the patent for etomidate expire?
The original composition patent for etomidate expired in 1997 (US Patent 4,011,849). However, other related patents, such as formulations and manufacturing processes, may still be in force. A patent for the IV injection formulation of etomidate, held by Hospira (now part of Pfizer), was patented in 1998 (US Patent 5725848).
Are there any additional patents or exclusivities that may affect etomidate?
Yes, the FDA-approved new drug application (NDA) for etomidate injection, currently marketed by Hospira and other generic manufacturers, includes a 5-year exclusivity for pediatric use granted in 2010 (DrugPatentWatch.com).
As a result, the etomidate injection may have a longer exclusivity window until 2015. However, this exclusivity does not cover off-patent composition of matter or formulations (DrugPatentWatch.com).
Are there any biosimilars for etomidate entering the market?
There are no FDA-approved biosimilars for etomidate injection available yet. However, several biosimilar applications are pending. In 2020, Viatris (formerly Mylan and Upjohn) submitted a biosimilar application for etomidate to the FDA.
In summary, while the original composition patent for etomidate expired in 1997, other related patents and exclusivities may still impact the market.
Sources:
[1] U.S. Patent and Trademark Office. (1977). U.S. Patent 4,011,849 - "Etomidate."
[2] U.S. Patent and Trademark Office. (1998). U.S. Patent 5,725,848 - "IV injection formulation of etomidate."
[3] DrugPatentWatch.com. (n.d.). Etomidate.