Baricitinib is a reversible selective JAK1/JAK2 kinase inhibitor that was first approved for marketing in the European Union in February 2017 and in China in June 2019. Currently, Baricitinib has been approved in China for the treatment of rheumatoid arthritis and severe alopecia areata. The drug is also the world’s first JAK inhibitor approved for the treatment of severe alopecia areata.
According to Eli Lilly’s financial reports, Baricitinib’s global sales in 2023 reached $922.6 million, nearing blockbuster status.
Compound Patent Invalidity:
Baricitinib’s compound patent CN200980116857.7, with the earliest priority date of March 11, 2008, was supposed to expire on March 10, 2029, but was declared entirely invalid by the National Intellectual Property Administration in January of this year. The requester for the invalidation was Nanjing Spark Pharmaceutical Technology Co., Ltd.
Crystal Form Patent Invalidity:
Recently, the National Intellectual Property Administration issued a decision on the invalidation request for Eli Lilly’s compound crystal form patent 201610136379.8, declaring the patent rights entirely invalid. The requester for the invalidation was Nanjing Yoko Bio.
The crystal form patent was applied for by Suzhou Crystal PharmaTech on March 10, 2016, and was authorized for publication on June 18, 2019, with an expiration date of March 10, 2026. The patent has been transferred from Suzhou Jingyun to Eli Lilly, with claim 1 protecting the specific compound crystal form of Baricitinib.
Seven generic versions of Baricitinib tablets have been filed for market approval. Among them, the generic Baricitinib tablet co-filed by Nanjing Yoko Bio and another company successfully obtained the first generic qualification in October 2023.
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