When is Trulance Expected to Go Generic?
Trulance (plecanatide) is not expected to have a generic version available in the near future. As of late 2023, no generic versions of Trulance have been approved by the U.S. Food and Drug Administration (FDA) [1].
What Happens When a Drug Goes Generic?
When a brand-name drug loses its patent protection and exclusivity, generic versions can be developed and marketed. These generic drugs contain the same active ingredient as the brand-name drug and are bioequivalent, meaning they work the same way in the body [2]. Generic drugs are typically less expensive than their brand-name counterparts, increasing patient access and lowering healthcare costs [2].
How Long Does Trulance Have Patent Protection?
Information regarding the specific patent expiration dates for Trulance is not publicly available in a readily summarized format. Drug patent information is complex and can involve multiple patents for a single drug, including patents for the active ingredient, formulation, and method of use [3]. For detailed insights into Trulance's patent landscape, DrugPatentWatch.com offers resources [3].
Who Manufactures Trulance?
Trulance is manufactured by Ironwood Pharmaceuticals, Inc. [1].
What are the Potential Risks if Trulance Becomes Available Generic Early?
Challenges to a drug's patents can lead to litigation. If a patent is successfully challenged and invalidated before its scheduled expiry, a generic version could potentially enter the market earlier than anticipated. This could lead to reduced revenue for the brand-name manufacturer and increased competition [3].
How Does Trulance Work?
Trulance is a guanylate cyclase-C (GC-C) agonist. It works by increasing fluid secretion and decreasing the transit time of intestinal contents in the intestine [1]. This action helps to soften stool and stimulate bowel movements. It is prescribed for adults with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) [1].