Nilotinib's Key Crystal Form Patent Invalidated in China, Opening Door for Generic Competition

Recently, the China National Intellectual Property Administration (CNIPA) issued an invalidation request examination decision for a polymorph patent CN200680026434.2 of Novartis, declaring the patent entirely invalid. The invalidation requester is an individual (Yang Xiaoyan).

Medcube NextPat DatabaseIt shows that this patent is a crystal form patent for Nilotinib, protecting the crystal form B of Nilotinib hydrochloride monohydrate. Its counterpart crystal form patent US8415363B2 has been included in the Orange Book, with essentially the same protective content. It can be confirmed that this patent is precisely the crystal form patent for the pharmaceutical compound Nilotinib.

Previously, Suzhou successfully challenged the key patents of Novartis' nilotinib in China: CN200680026444.6 (protecting the pharmaceutical salt compound of nilotinib) and CN201080051819.0 (protecting the marketed indications of nilotinib).

The compound patent for nilotinib in China expired this July. After the aforementioned crystal form patent was invalidated, the key patent obstacles that significantly hindered domestic generic versions of nilotinib have all been removed.

Nilotinib was approved for marketing by the FDA in October 2007 and entered the Chinese market in July 2009. Its excellent therapeutic effects and market performance have attracted significant attention from domestic generic drug companies, with multiple enterprises competing to develop generics.

ThroughMagic Cube PharmaGO DatabaseIt can be queried that the products of Suzhou Tere Pharmaceutical have been approved for marketing, and five pharmaceutical companies including Jiangsu Hengrui Medicine, Sichuan Difite Pharmaceutical, and Simcere Pharmaceutical have also submitted their applications for marketing.

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