While the wave of small molecule drug therapies going off patent has peaked, there are still a number that will be losing patent protection over the coming years. The need for rapid development of new generic equivalents is as critical as it has ever been. One of those drugs reaching the end of its patent life is Tiotropium, an anticholinergic agent used in the treatment of lung diseases. “Tiotropium was patented in 1989 and approved for medical use in 2002. In 2016 it was the 95th most prescribed medication in the United States with more than 8 million prescriptions. There is no generic version available in the United States as of 2019.” *
While there are a number of patents on Tiotropium, one of them expires this year, 2019, opening the door for the development of generic and branded generic competition. QPS has developed a non-proprietary LC-MS/MS assay for Tiotropium @ LLOQ 0.100 pg/mL human plasma. If your company is interested in developing a 505(b)(2) version of Tiotropium, please reach out to us and see how we can help to fast-track your project. Contact QPS today!
QPS is a leader in developing small and large molecule assays, and has over 800 assays developed and available for clients to choose from when looking to develop their next therapeutic agent. The on-line assay finder can be accessed here and links to the Apple and Android apps can be found here. In addition, QPS is an expert provider of method development to create custom assays for new therapeutic agents.
Since 1995, QPS has provided discovery, preclinical, and clinical drug development services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email [email protected].