Puli Pharmaceuticals successfully won the best-selling anticoagulant ANDA in a patent challenge

Medical Network, June 2 News On May 31, Puli Pharmaceuticals issued an announcement stating that the company had recently received a notice of approval for the marketing of a generic bivalrudine for injection issued by the FDA.
The product is one of the company's co-production varieties.
Data shows that the company has already won the ANDA number of seven products, which has a positive impact on the company's expansion in the US market.

 

Table 1: Puli Pharmaceuticals approved product information

Source: Company announcement

 

Figure 1: The situation of the enterprises that have obtained the production approval of bivalrudine for injection in the domestic market

Source: One-click search on Mi Nei.
com

 

Bivarudin for injection is a synthetic anticoagulant drug.
In 2020, the terminal sales of China's urban public hospitals , county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) will exceed 500 million.
Yuan, Hainan Puli Pharmaceutical’s 4 types of generic listing applications were approved in September 2020 and deemed to have been reviewed.
At present, 7 pharmaceutical companies in the domestic market have obtained production approval for this product (including 1 original research import).

 

Puli Pharmaceuticals mentioned in the announcement that the company's bivalrudine for injection is a co-line production variety and was temporarily approved by the FDA in December 2020.
Currently, the original American product is still under patent protection, and the patent period is until 2029.
January 27.

 

　　Preliminary Pharmaceuticals submitted a PIV patent (patents related to the applied generic drugs are invalid or non-infringing) statement to the FDA in January 2021, and also to the original researcher and the holder of the marketing license for bivalerudin for injection.
The patent holder initiated a patent challenge, and the original research company did not initiate any litigation against the patent challenge of Bivarridine for injection by Puli Pharmaceutical within 45 days after receiving the notice.
That is, the company successfully challenged the patent for bivalerudin for injection and then succeeded The company notified the FDA of the above progress and submitted an application for final marketing approval of a generic bivalrudine for injection.
Recently, the company received the FDA's notification of marketing approval, which indicates that the company has the qualification to sell bivalridine for injection in the United States.

 

　　Table 2: The ANDA document numbers that Puli Pharmaceutical has obtained earlier

　　Source: Meinenet Global Listed Drug Database

 

　　According to data from Minai.
com, Puli Pharmaceuticals has obtained the ANDA number of 7 products earlier.
The approval of Bivarrudin for injection this time will help improve the company's sales in the US market.

 

　　Source: Company announcement, Mi Neiwang database

　　Medical Network, June 2 News On May 31, Puli Pharmaceuticals issued an announcement stating that the company had recently received a notice of approval for the marketing of a generic bivalrudine for injection issued by the FDA.
The product is one of the company's co-production varieties.
Data shows that the company has already won the ANDA number of seven products, which has a positive impact on the company's expansion in the US market.

 

　　Table 1: Puli Pharmaceuticals approved product information

　　Source: Company announcement

 

　　Figure 1: The situation of the enterprises that have obtained the production approval of bivalrudine for injection in the domestic market

　　Source: One-click search on Mi Nei.
com

 

　　Bivarudin for injection is a synthetic anticoagulant drug.
In 2020, the terminal sales of China's urban public hospitals , county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) will exceed 500 million.
Yuan, Hainan Puli Pharmaceutical’s 4 types of generic listing applications were approved in September 2020 and deemed to have been reviewed.
At present, 7 pharmaceutical companies in the domestic market have obtained production approval for this product (including 1 original research import).

 

　　Puli Pharmaceuticals mentioned in the announcement that the company's bivalrudine for injection is a co-line production variety and was temporarily approved by the FDA in December 2020.
Currently, the original American product is still under patent protection, and the patent period is until 2029.
January 27.

 

　　Preliminary Pharmaceuticals submitted a PIV patent (patents related to the applied generic drugs are invalid or non-infringing) statement to the FDA in January 2021, and also to the original researcher and the holder of the marketing license for bivalerudin for injection.
The patent holder initiated a patent challenge, and the original research company did not initiate any litigation against the patent challenge of Bivarridine for injection by Puli Pharmaceutical within 45 days after receiving the notice.
That is, the company successfully challenged the patent for bivalerudin for injection and then succeeded The company notified the FDA of the above progress and submitted an application for final marketing approval of a generic bivalrudine for injection.
Recently, the company received the FDA's notification of marketing approval, which indicates that the company has the qualification to sell bivalridine for injection in the United States.

 

　　Table 2: The ANDA document numbers that Puli Pharmaceutical has obtained earlier

　　Source: Meinenet Global Listed Drug Database

 

　　According to data from Minai.
com, Puli Pharmaceuticals has obtained the ANDA number of 7 products earlier.
The approval of Bivarrudin for injection this time will help improve the company's sales in the US market.

 

　　Source: Company announcement, Mi Neiwang database