XuanTai Pharma Submits Second Domestic ANDA for Olaparib to NMPA

Source: PharmaCube Info

Author: info

On January 27, the CDE website showed that Sinotherapeutics' Olaparib generic drug application, filed under Category 4, was accepted by the National Medical Products Administration (NMPA). This marks the second generic version of the product to have its marketing application submitted.

Olaparib is the first oral poly ADP-ribose polymerase (PARP) inhibitor approved by the FDA. By inhibiting PARP enzyme activity and preventing PARP from dissociating from DNA, it synergizes with defects in DNA damage repair functions to kill tumor cells. The original research company is AstraZeneca, and the product was first approved for marketing in the EU and the US in 2014, under the trade name Lynparza.

Olaparib was first approved for marketing by the NMPA in August 2018, as the first PARP inhibitor launched in China. It has been previously approved in China for the treatment of:

1) Maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response to platinum-based chemotherapy.

2) Maintenance treatment for adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer harboring germline or somatic BRCA mutations (gBRCAm or sBRCAm) who have achieved complete response or partial response to first-line platinum-based chemotherapy.

3) As a single agent for the treatment of adult patients with metastatic castration-resistant prostate cancer harboring germline or somatic BRCA mutations (gBRCAm or sBRCAm) who have failed prior therapy (including a novel endocrine agent).

Global sales of the original Olaparib drug reached 2.501 billion US dollars in 2020, making it the highest-selling product among the six PARP inhibitors available on the global market. According to the PharmaGo database by Medicine Magic Cube, Qilu Pharmaceutical has already filed for a generic version of Olaparib. Other companies currently developing a generic version of this product include Hansoh Pharmaceutical, Zhengda Tianqing, and Shandong Luoxin.

According to the CDE Patent Registration Platform, the compound patent for Olaparib will expire in March 2024, the formulation patent will expire in October 2029, and the use patent will expire in November 2024.

Qilu Pharmaceutical has submitted a Class 3 patent declaration on the website while filing for the generic drug's market approval, pledging that the applied generic drug will not be launched until the expiration of the corresponding patent term.