The FDA has granted new drug product exclusivity to Evoke Pharma Inc's (NASDAQ: EVOK) Gimoti (metoclopramide) nasal spray to relieve symptoms associated with acute and recurrent diabetic gastroparesis in adults.
Evoke now has exclusive marketing rights over three (3) years from the original date of approval under the Hatch-Waxman Act to protect the product from generic drug competition.
In addition to the market exclusivity, Evoke maintains a robust patent estate, with currently two Orange book-listed patents that expire in 2029 and 2030.
The Company has also been granted gender-specific patents in the EU, Japan, and Mexico until 2032.
Furthermore, if approved, Evoke has other pending patent applications with individual expiration dates of 2032, 2037, and 2038.
