Simcere Pharmaceutical's "ibrutinib" first generic approved for marketing! Original Research Institute's sales in 2021 were USD 9.8 billion

On October 14, Simcere Pharmaceutical ibrutinib capsules were approved for marketing by the State Food and Drug Administration and are the first imitation
of the product.

Ibrutinib is the world's first marketed BTK inhibitor, and the original product Imbruvica was developed
by Johnson & Johnson and Pharmacyclics.
It was first approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL).

In March 2015, AbbVie acquired Pharmacyclics for $21 billion, acquiring commercial rights to ibrutinib in the U.
S.
market, while Johnson & Johnson owns commercial rights
in other countries around the world.

Up to now, ibrutinib has been approved by the FDA for a number of indications, including mantle cell lymphoma, graft-versus-host disease, marginal zone lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia
.
In August 2017, the product entered the Chinese market and has been approved for the treatment of patients with mantle cell lymphoma, chronic lymphoblastic leukemia, small lymphocytic lymphoma and Waldenstrom macroglobulinemia
.
Since its listing, the ibrutinib market has performed very well
.
However, in 2021, due to the competition for similar competitors, the growth rate of ibrutinib slowed down, with global sales of 9.
78 billion US dollars
.
However, after the patent for lenalidomide expires, ibrutinib may become the new small molecule "king"
in the field of tumors.

According to the PharmaGO database, domestic companies such as China and the United States East China, Hisun Pharmaceutical, and Chia Tai Tianqing are also developing generic ibrutinib
.

At present, there are 5 BTK inhibitors on the
market worldwide.
In 2021, both acalabrutinib and zebrutinib grew strongly, reaching $1.
238 billion and $218 million
, respectively.
Among them, zebrutinib domestic sales were 101.
2 million US dollars, accounting for almost half
of the global sales of the product.
Ono Pharma and Gilead's Velexbru and InnoCare's orelabrutinib are only available in
Japan and China, respectively.

From the perspective of the listed BTK inhibitor indications, ibrutinib is in a leading position in the world, with 6 indications approved and 3 indications in the phase III clinical stage
.
Zebrutinib is in the second order and has been approved for 5 indications
.

Source: NextPharma

According to the information published on the China Listed Drug Patent Information Registration Platform, Johnson & Johnson has registered 2 ibrutinib patents in China, and its compound patent will expire
on December 27, 2026.