US 12245997

US patent 12245997, titled "Endoxifen for the treatment of bipolar I disorder," was issued to Jina Pharmaceuticals Inc. on March 11, 2025. The patent application was filed on April 9, 2021. The inventors listed are Ateeq Ahmad, Imran Ahmad, Moghisuddin AHMAD, Shoukath M ALI, and Saifuddin Sheikh.

Abstract:
The patent describes a method for treating a patient with bipolar I disorder by maintaining a therapeutically effective concentration of endoxifen. This method involves administering a dose of 2 mg to 16 mg of endoxifen citrate in an enteric-coated tablet once daily for at least 21 days. A key aspect of this method is that the patient does not require rescue medication during the administration of endoxifen citrate.

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim outlines a method for treating a patient with bipolar I disorder. It involves giving the patient an enteric-coated tablet containing 2 mg to 16 mg of endoxifen citrate once a day for up to 21 days. A specific condition of this method is that no rescue medication is needed for the treatment of bipolar I disorder during this period.
• Independent Claim 6: This claim also describes a method for treating a patient with bipolar I disorder, similar to Claim 1. It involves administering 2 mg to 16 mg of endoxifen citrate in an enteric-coated tablet once daily for up to 21 days. Additionally, this claim specifies that the dose administered to the patient is monitored no sooner than 21 days after the treatment begins. Like Claim 1, this method explicitly excludes the need for rescue medication for bipolar I disorder treatment.

Litigation Status:
The patent family is currently involved in litigation. A Post-Grant Review (PGR) case, PGR2026-00015, has been filed and is pending before the Patent Trial and Appeal Board (PTAB).