Over $10 billion, the big variety meets the enemy Fu, Hausen... 78 ANDAs are won

On February 14, the US FDA official website released the 2021 Generic Drug Annual Report.
The FDA Generic Drug Group (OGD) approved 736 ANDA projects throughout the year.
Among them, new crown drugs have become a hot spot.
In addition, many varieties have sales during 2021.
Eye-catching, lenalidomide capsules exceeded 10 billion US dollars
.
78 ANDA numbers (65 varieties) come from domestic companies, involving 28 pharmaceutical companies (in terms of groups), of which Fosun Pharma ranks first with 16 ANDA numbers, followed by Jianyou with 14
.
The report shows that in 2021, the FDA Generic Drug Group (OGD) approved 736 ANDA projects, of which 593 were finally approved and 143 were temporarily approved
.
Under the epidemic, more than 75 original ANDAs were approved as generic drugs for potential treatment supportive therapy for COVID-19 patients, including dexamethasone injection, propofol emulsion injection and dexmedetomidine hydrochloride injection, etc.

.
It is worth noting that OGD approved 93 first generic drugs in 2021, of which there are 11 important first generic drugs designated by the FDA, including: linaclotide capsules, apremilast tablets, hydrocodone tartrate sustained-release tablets, Ibrutinib capsules, enzalutamide capsules, lenalidomide capsules, tofacitinib tablets, difluprednate ophthalmic lotion, varenicline tablets, linagliptin tablets, dasatinib tablets
.
From the perspective of global sales, many varieties performed well
.
According to Minet data, in 2021, the global sales of Bristol-Myers Squibb's lenalidomide will reach US$12.
821 billion, Amgen's Apsit will reach US$2.
249 billion, and Bristol-Myers Squibb's Dasatinib will reach 21.
17 billion US dollars.
$1.
185 billion for Pfizer’s enzalutamide and $1.
038 billion for AbbVie’s linaclotide
.
In addition, among competing generic drug (CGT) approvals, the FDA has approved 119 CGT-eligible generic drug products from the start of approval implementation in 2017 to December 31, 2021, of which 52 were approved during the full year of 2021.
indivual
.
The number of ANDA numbers of domestic pharmaceutical companies TOP5 Among the 736 ANDA numbers, 78 were obtained by domestic companies, involving 28 pharmaceutical companies (in terms of groups), with a total of 65 varieties (in terms of drug name + company name), which is similar to last year.
Than, Aokeda, Beijing Tide, etc.
are the new enterprises this year
.
ANDA approved by the FDA in 2021 for Chinese pharmaceutical companies Get 6, 4, and 3 ANDA numbers respectively
.