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At the end of June 2022, the U.
Court of Appeals for the Federal Circuit ruled that East Sunshine successfully invalidated Novartis' indication patent
On October 14, 2022, the first batch of fingolimod capsules produced by Guangdong East Sunshine Pharmaceutical Co.
has successfully arrived at the US distributor's warehouse
after a long journey.
On October 18, 2022, the US court officially ruled that the US9187405 patent was invalid, and fingolimod capsules were officially put on sale in the United States, marking East Sunshine becoming the first Chinese company to challenge the original drug patent in the United States and succeed.
Figure 1: Fingolimod capsules produced by East Sunshine
East Sunshine is one of the earliest pharmaceutical companies in China to deploy generic drugs of fingolimod.
The Fingolimod project was approved in July 2011 and has been declared in China, the United States and the European Union, of which it has been approved
in Europe (Spain, Germany and Italy) and the United States.
China's NMPA has accepted the application for registration of the project in February 2020, and due to the restrictions of laws and regulations, the product is expected to be approved for marketing
In September 2014, East Sunshine filed an initial ANDA application with a PIV patent claim with the US FDA, and subsequently issued a challenge letter to the original research Novartis to challenge the validity of
two OB patents (US5604229 patent and US8324283 patent).
Novartis sued East Sunshine in February 2015 for the above two patents, in which the '283 preparation patent was invalidated by other manufacturers in the course of the litigation, and the patent was finally invalidated
by the Court of Appeal.
The other '229 patent, a compound patent, has a strong stability, which has gone through the first instance and appeal of the district court, and finally reached a settlement
between the two parties at the end of 2017.
In December 2015, Novartis added the newly granted US9187405 patent to the OB, while other manufacturers proposed that the IPR was invalid.
In July 2018, the IPR result maintained the validity of the patent, and the other companies settled and withdrew from the lawsuit, and only East Sunshine insisted on the trial
The patent was upheld in the first instance, and East Sunshine appealed to the Federal Circuit Court of Appeals against the judgment; In January 2022, in the second instance trial, East Sunshine lost the case; Subsequently, East Sunshine filed a request for review; On June 22, 2022, the Federal Court overturned the original decision and ruled that the '405 patent was invalid, and Novartis subsequently applied to the Federal Court for full review, which was rejected by the Federal Court on September 20, 2022; on October 18, 2022, the formal decision on the invalidation of the '405 patent was issued
At this point, East Sunshine has become the only manufacturer in the American ANDA lawsuit that challenged the Fingolimod patent and persisted to the final victory!
The success of the Fingolimod patent challenge is of great significance
to East Sunshine.
On the one hand, fingolimod, as the world's first oral drug for the treatment of adult multiple sclerosis, has broad market prospects, and the global drug market size of multiple sclerosis is about 23 billion US dollars
According to the GBI SOURCE global drug database, the global sales of innovator drugs reached US$2.
Novartis predicts that once generic drugs hit the market, they could result in a loss of $300 million in revenue in
On the other hand, the successful launch of Fingolimod's first generic drug in the United States marks a new chapter
in the road of internationalization of East Sunshine.
East Sunshine is the enterprise with the most patent challenges by domestic pharmaceutical companies in the United States, and can learn from the successful experience of patent challenges and continue to develop more excellent products
in the future.
At the same time, in the field of innovative drugs, East Sunshine has a long-term layout in many fields, and has a strong product pipeline
in the fields of anti-infection, tumor and metabolism.
In summary, East Sunshine has strong comprehensive research and development capabilities of the first generic drug in the United States, overseas generic drugs and improved new drugs, and will continue to promote East Sunshine to become a leading domestic and internationally renowned leading pharmaceutical enterprise
through the dual engines of "innovation" and "internationalization" in the future.
At present, Guangdong East Sunshine Pharmaceutical Co.
is actively promoting the IPO work, with a round A valuation of more than 20 billion yuan in 2021, attracting investment from
well-known institutions such as IDG Capital, Guangdong Hengjian, China Capital and Cinda Asset.
The successful listing of Fingolimod in the United States will bring a large amount of cash flow to the company, bring confidence to the majority of investors, and also put the company's asset securitization into the fast lane