AMAG Pharmaceuticals, Inc announced the issuance of U.S. Patent Number 9,844,558 entitled “Methods of Reducing Risk of Preterm Birth.” This newly issued patent is directed to subcutaneous administration and dosing of Makena® (hydroxyprogesterone caproate injection) and is expected to expire on May 2, 2036. Makena is a treatment to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.
The U.S. Food and Drug Administration (FDA) established a Prescription Drug User Fee Act (PDUFA) target action date of February 14, 2018 for the Makena subcutaneous auto-injector, a drug-device combination product. If approved, the auto-injector will join the Makena portfolio, which also includes the FDA-approved intramuscular injection.
“Securing this patent is another important step in our preparation to bring the Makena subcutaneous auto-injector to market,” said William Heiden, AMAG’s president and chief executive officer. “If approved, this drug-device combination will offer health care providers with a ready-to-administer product and provide women with an alternative option to an intramuscular injection. We believe that this auto-injector will help more women who may be at risk for recurrent preterm birth.”
AMAG developed the Makena auto-injector with its device partner Antares Pharma, Inc. (NASDAQ:ATRS), which holds issued patents on the auto-injector device and drug device combination. If approved, AMAG will request FDA Orange Book listing of this new patent, as well as the eligible Antares patents.
