Orient Pharma announced on the 4th that its independently developed “multi-layer release technology platform” has successfully produced a generic version of tofacitinib using the OROS osmotic-controlled release system, successfully challenging the original patent. The generic is expected to launch in the U.S. as early as June 2026. The drug is primarily used for the treatment of rheumatoid arthritis.

Orient Pharma stated that the original tofacitinib is a Pfizer product with a patent valid until 2034. The company had previously submitted a patent challenge (P4) to the U.S. FDA and, on September 4, received a “non-litigation commitment letter” from Pfizer, clearing the way for FDA review and approval.

Beyond the U.S. market, Orient Pharma is negotiating with Pfizer Taiwan on patent issues. If a similar approach allows an earlier launch in Taiwan, it will further expand the market potential.

The demand for rheumatoid arthritis treatment is growing rapidly, and the global market is substantial. Statistics show that the U.S. tofacitinib market is approximately NT$75 billion, while Taiwan’s market reached NT$700 million in 2023.

General Manager Huang Chun-Tong stated that Orient Pharma is pursuing an international expansion strategy through a dual approach of “patent challenge” and “repurposing established drugs.” Once the tofacitinib generic is successfully launched in both the U.S. and Taiwan, the company plans to simultaneously advance into European and Asian markets, leveraging the U.S. and Taiwan experiences for rapid replication and accelerated global deployment.

Since achieving profitability in 2023, Orient Pharma has focused on its multi-layer drug release technology platform, developing three core technologies: semi-solid multi-layer release (SMART), multi-unit pellet system (MUPS), and osmotic-controlled release system (OROS). The company operates a manufacturing facility built to international standards, becoming Taiwan’s first newly established plant compliant with PIC/S GMP, EU GMP, and U.S. FDA 21 CFR regulations.

Chairman Peter Tsai emphasized that Orient Pharma has extended its operations to five continents and 12 countries, holding over 50 drug approvals covering Taiwan, the U.S., Southeast Asia, and other markets. In Taiwan, the company’s products are available in 23 medical centers, 86 regional hospitals, and 4,602 clinics, forming a comprehensive and deep medical distribution network. In addition to securing local approvals and market entry, Orient Pharma is accelerating expansion into China, Europe, the U.S., and Japan, while simultaneously submitting New Drug Application (NDA) filings in Hong Kong, Singapore, Malaysia, the Philippines, and Vietnam to broaden its market footprint.

Resource: 友霖成功挑戰輝瑞專利 Tofacitinib學名藥可望2026登美