The United States Patent and Trademark Office (USPTO) has granted three new patents to Synergy Pharmaceuticals covering Trulance (plecanatide).

The first patent relates to the method for manufacturing Trulance and will expire March 1, 2032. The two other patents relate to formulations and methods of using Trulance for treating chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) at 3mg or 6 mg dose; both of these patents will expire September 15, 2031.

“We are very pleased these additional patents were allowed and issued as they are a significant addition to the Trulance patent portfolio, providing extended exclusivity protection for Trulance”, said Dr. Gary S. Jacob, chairman and chief executive officer of Synergy Pharmaceuticals Inc. “This marks an important step in our ongoing efforts to optimize the value of Trulance.”

Trulance is a once-daily tablet approved by the Food and Drug Administration (FDA) for the treatment of adults with CIC and is currently being evaluated for the treatment of adults with IBS-C. The company began marketing Trulance in the U.S. for adults with CIC on March 20, 2017. The recommended dosage of Trulance is 3 mg taken orally, once daily, with or without food at any time of the day.

On March 24, 2017, the company submitted a supplemental New Drug Application (sNDA) for Trulance for the treatment of adults with IBS-C.

Trulance is a guanylate cyclase-C (GC-C) agonist indicated in adults for the treatment of chronic idiopathic constipation (CIC).

Trulance (plecanatide) is a once-daily tablet approved for adults with CIC and is being evaluated for IBS-C. With the exception of a single amino acid substitution for greater binding affinity, Trulance is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.

Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies.