Synergy Pharmaceuticals announces issuance of three new patents expected to extend Trulance (plecanatide) patent protection until 2032.

Synergy Pharmaceuticals Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued three new patents 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 those 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.

(Source: Business Wire)