China-based Suzhou Thery Pharmaceutical Inc. has announced that the National Medical Products Administration (NMPA) has approved its generic version of Novartis’s (NYSE: NVS) cancer therapy Tasigna (nilotinib). Thery filed a “4.1 certification” under China’s patent linkage system, directly challenging the validity of Tasigna’s patent. Thery is the first company to successfully do so since the linkage system was established in July 2021.
Patent Linkage System and Market Exclusivity
Under China’s patent linkage system rules, the first generic company to file a 4.1 certification against an originator drug and successfully win both the patent challenge case and approval is awarded 12 months’ market exclusivity alongside the originator. This means that no further generic will be approved for one year. Fineline Info & Tech’s IP Radar system shows that Suzhou Thery’s 4.1 filing was first publicized by the Center for Drug Evaluation (CDE) in November 2021, while Qilu Pharmaceutical made a 4.2 category filing (indicating that it viewed its generic as non-infringing) two months later.
Therapeutic Profile and Market Impact
Nilotinib is a tyrosine kinase inhibitor (TKI) used to treat chronic myeloid leukemia (CML), particularly in patients resistant or intolerant to first-generation TKI imatinib. Fineline Info & Tech data show that Novartis’s compound patent for nilotinib was not expected to expire until 2026, and it also had an indication patent running until 2030. Thery Pharma boasts 14 products with generic quality consistency evaluation (GQCE) qualification, alongside 29 active pharmaceutical ingredients (APIs) with registration numbers in China.
Future Outlook
The approval of Thery’s generic version of nilotinib highlights the company’s strategic approach to challenging patents and expanding its market presence. With 12 months of market exclusivity, Thery is well-positioned to capture a significant share of the market for this essential cancer therapy. The company’s ongoing efforts in generic drug development underscore its commitment to providing affordable and high-quality medications to patients.-Fineline Info & Tech
