In a significant boost to its intellectual property portfolio, U.S.-based clinical-stage biopharmaceutical company ABVC BioPharma has received a key patent grant in Japan for its novel antidepressant candidate, ABV-1504. The newly issued patent secures exclusive rights in Japan for the innovative botanical-based treatment through 2040, reinforcing the company’s commitment to addressing global mental health challenges with plant-derived therapies.
ABV-1504, currently under clinical development for Major Depressive Disorder (MDD), is formulated from PDC-1421, a proprietary compound extracted from the traditional medicinal herb Polygala tenuifolia. This active ingredient acts as a Norepinephrine Transporter (NET) inhibitor and has shown encouraging safety and efficacy in Phase II clinical trials, offering a potentially safer and non-addictive alternative to conventional treatments like selective serotonin reuptake inhibitors (SSRIs).
The Japanese patent adds to ABVC’s existing IP protections in the United States, Australia, and Taiwan, ensuring broad international coverage for PDC-1421. With depression affecting more than 280 million people globally, and the antidepressant market projected to reach $20 billion by 2030, ABV-1504 positions itself as a differentiated and promising therapy in a growing global landscape.
“Securing patent protection in Japan is a critical achievement for ABV-1504 and reflects our broader strategy to provide innovative, plant-based solutions for central nervous system disorders,” said a company representative. “Japan’s healthcare system, which has long embraced botanical therapies, represents an ideal market for introducing this novel treatment.”
Japan presents strong commercial potential for ABV-1504. With over 5 million people suffering from depression and the country’s antidepressant market expected to surpass $1.25 billion by 2025, ABVC sees the region as a vital part of its global expansion strategy. The integration of herbal medicine into Japan’s modern healthcare practices further enhances market readiness for scientifically validated botanical alternatives.
To accelerate market access and local engagement, ABVC established BioLite Japan K.K., a joint venture led by a former Pfizer executive with deep experience in the Asia-Pacific pharmaceutical industry. Through this entity, ABVC is actively collaborating with regulatory bodies, academic institutions, and local industry leaders to prepare for future clinical and commercial developments in the region.
In a parallel development, ABVC signed a global licensing deal in November 2023 with AiBtl BioPharma Inc., valued at $667 million. The agreement includes milestone payments and royalties based on future commercialization success, underscoring investor confidence in the compound’s potential.
The issuance of the Japanese patent represents a major milestone for ABVC BioPharma as it continues its mission to redefine the treatment landscape for mental health disorders. By advancing a botanical-based solution with proven clinical promise, ABVC aims to offer patients a new path toward safer and more sustainable depression management.