Lamotrigine hydrate crystal form, preparation method, and composition

The USPTO has granted Patent US12595237B2 for a lamotrigine hydrate crystal form (Form A), a method of preparing said crystalline form, and compositions comprising the same. The patent, with inventors Shoufeng Li, Yong Wang, and Boli Li, was filed on April 18, 2022, under Application No. 18555659. The grant provides intellectual property protection for this specific solid-state form of the pharmaceutical compound.

For affected parties, this patent grant gives Shanghai Aucta Pharmaceuticals Co., Ltd. exclusive rights to make, use, and sell products incorporating this lamotrigine hydrate crystal form in the United States. Competing pharmaceutical manufacturers seeking to develop generic lamotrigine products may need to design around this patent, pursue invalidation proceedings, or seek licensing arrangements. The 13 granted claims provide broad protection covering the crystal form itself, methods of preparation, and pharmaceutical compositions containing the form.