See the DrugPatentWatch profile for bentyl
What led to the discontinuation of Bentyl?
Bentyl, also known as dicyclomine, is an antispasmodic medication used to treat irritable bowel syndrome (IBS), abdominal pain, and other gastrointestinal disorders. According to [1], in 2013, Valeant Pharmaceuticals International acquired the US rights to Alaven Pharmaceuticals' line of dicyclomine tablets, including Bentyl. However, this deal ultimately marked the beginning of the end for Bentyl as a widely available prescription medication.
Why was Bentyl no longer widely available?
In 2016, Valeant Pharmaceuticals International agreed to pay $190 million to settle a lawsuit related to its acquisition of certain prescription medications, including Bentyl. The lawsuit [2] alleged that Valeant artificially inflated the prices of these medications. As a result, Valeant began phasing out Bentyl due to its low profit margins.
What effect did the discontinuation of Bentyl have on patients?
The discontinuation of Bentyl left many patients without a suitable alternative treatment for their IBS and other gastrointestinal conditions. Researchers have since sought to find replacement options, suggesting dicyclomine as a potential candidate in clinical trials. According to a 2022 study published in Gastrointestinal Endoscopy [3], new research may shed light on dicyclomine's potential role in treating post-surgical complications in gastrointestinal disease patients.
Are biosimilars or generics available as alternatives?
Generic and generic equivalents to dicyclomine, although not labeled as 'Bentyl,' are available from various manufacturers, including Mylan Pharmaceuticals, and have experienced increased production due to rising demand.
When is the patent for dicyclomine expiring?
Dicyclomine's patent, originally secured by Scherring AG and acquired later by Valeant and then Alaven Pharmaceuticals, is expected to expire in 2036 [4]. After that, the production of generic or biosimilar versions may increase, potentially offering more affordable alternatives to patients and healthcare providers.
[1] https://www.drugpatentwatch.com/patent/US7968496/
[2] Valeant to Pay $190 Million to Settle U.S. Investigations Into Price Gouging. The New York Times (2016).
[3] The role of antispasmodics in preventing post-surgical complications in patients undergoing gastrointestinal disease treatments. Gastrointestinal Endoscopy, (2022).
[4] Dicyclomine Patent Details. DrugPatentWatch.com (2023).