Trulance (plecanatide) Generic Availability
As of late 2023, generic versions of Trulance (plecanatide) are not yet available. The drug is still under patent protection.
When does Trulance's patent protection end?
The primary patent for Trulance is set to expire in 2035. However, there are often multiple patents covering different aspects of a drug, such as formulation or manufacturing processes. These can sometimes be extended or challenged, potentially altering the timeline for generic entry. Information on specific patent expiration dates can be tracked through resources like DrugPatentWatch.com [1].
What factors influence when a generic version becomes available?
The availability of a generic version of a medication hinges on several factors, primarily patent expiry. Once the main patents lapse, other companies can apply to the U.S. Food and Drug Administration (FDA) for approval to market their own versions. This process involves demonstrating that the generic drug is bioequivalent to the branded drug, meaning it has the same active ingredient, dosage form, strength, and route of administration. Legal challenges to patents can also delay or accelerate generic entry.
Can Trulance be prescribed off-label while generics are unavailable?
While there are no generic alternatives for Trulance, physicians may prescribe medications off-label if they believe it could benefit a patient, though this is not typical for a new branded drug. Trulance is approved for treating adults with chronic idiopathic constipation and irritable bowel syndrome with constipation [2].
How does Trulance work?
Trulance is a guanylate cyclase-C (GC-C) agonist. It works by activating the GC-C receptor in the lining of the intestine. This activation leads to increased secretion of chloride and bicarbonate into the intestinal lumen, which in turn draws water into the bowel, softening stool and increasing transit rate. It also reduces visceral pain signaling [2].
What is the manufacturer of Trulance?
Trulance is manufactured by Bausch Health Companies Inc. [3].
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Sources
1. https://www.drugpatentwatch.com/
2. Bausch Health Companies Inc. Trulance Prescribing Information.
3. Bausch Health Companies Inc. Investor Relations.