Orient Pharma (OP) announced on March 1 the execution of a commercial agency agreement with Cipla/Invagen Pharmaceuticals, a top-10 global generic manufacturer. The deal grants Cipla exclusive rights to market OEP’s proprietary Tofacitinib XR (11mg/22mg), a long-acting oral extended-release generic, in the United States.

• Financial Terms: Cipla will provide an upfront payment, followed by milestones for FDA approval and commercial launch. Profit-sharing will be calculated based on net sales, ensuring a scalable, cost-efficient revenue stream for OEP.
• Strategic Milestone: This marks OEP’s third successful Paragraph IV (P4) patent challenge, following its successes with Pitavastatin and Ezetimide. Chairman Calvin Tsai emphasized that Tofacitinib XR is OEP’s first OROS (Osmotic-controlled Release Oral-delivery System) generic to hit the U.S. market, signifying a qualitative breakthrough in complex formulation manufacturing.
• Growth Platforms: OEP is leveraging three core technology platforms—SMRT (Semi-solid Multi-layer Release), MUPS (Multi-Unit Pellet System), and OROS—to drive mid-to-long-term margin expansion.
• Market Scale: According to 2025 IQVIA data, global annual sales of Tofacitinib XR reached $1.8 billion, with the U.S. market accounting for 90% of total demand.

Resource: 友霖與學名藥大廠 Cipla 簽商業代理合約 推動第三個P4藥進入美國市場