Handa Pharmaceuticals, Inc.

Company overview. Handa Pharmaceuticals, Inc. (漢達生技醫藥股份有限公司; commonly "Handa Pharma"), headquartered at the Southern Taiwan Science Park in Tainan City, Taiwan, was incorporated on May 8, 2014 by founder and chairman Bill (Fangyu) Liu, Ph.D. It is publicly traded on the Taipei Exchange (TPEX: 6620) since December 2016. PitchBook reports roughly 48 employees; trailing-twelve-month revenue is about NT$1.7 billion (~US$55 million), with a market cap ranging from roughly NT$15–25 billion (US$400–700M) depending on reporting date.

Products / operations. Handa is a specialty pharmaceutical company that develops 505(b)(2) new drugs and high-barrier, patentable niche generics for the U.S. and China markets, built on its drug-delivery/controlled-release platform (branded "ONCORE"). Its FDA-approved product is Tascenso ODT (fingolimod orally disintegrating tablets, project HND-020) for multiple sclerosis — approved December 23, 2021 (0.25 mg) and December 9, 2022 (0.5 mg) — along with marketed generics such as quetiapine XR, dexlansoprazole DR capsules, and PHYRAGO (dasatinib) via U.S. subsidiaries. Pipeline candidates span oncology (HND-033, HND-027), diabetes (HND-004), and smoking cessation (HND-032). Its U.S. affiliates — Handa Pharma, Inc., Handa Pharmaceuticals, LLC, Handa Neuroscience, LLC, and Handa Therapeutics, LLC — share an office in San Jose, California.

Patent-litigation posture. Handa is an operating company, not an NPE: of its two tracked cases, both are as defendant in the District of Delaware, both filed by Novartis Pharmaceuticals Corp. The suits are Hatch-Waxman-style 35 U.S.C. § 271(e) infringement actions arising from Handa's 505(b)(2) NDA No. 214962 for fingolimod ODT 0.5 mg (Tascenso ODT), a version of Novartis's Gilenya®. Venue is Delaware, not the Eastern District of Texas.

Notable cases. The tracked matters are Novartis Pharmaceuticals Corp. v. Handa Pharmaceuticals, Inc. (D. Del., filed 2022-03-21, No. 1:22-cv-00352) and Novartis v. Handa Neuroscience, LLC et al. (D. Del., No. 1:21-cv-00645, filed 2021-05-04, terminated 2022-10-26), with parallel litigation in the Northern District of California. Novartis asserted Gilenya patents (e.g., U.S. 9,187,405; 10,543,179); Handa counter-positioned with its own formulation patents covering Tascenso ODT (U.S. 9,925,138; 10,555,902; 10,925,829, assigned to Handa Neuroscience, LLC). FDA records note the 0.5 mg strength was withheld from final approval pending resolution of these suits.