NEWS

Huahai Pharmaceutical "pregabalin capsule" ANDA was temporarily approved by the United States

Release time:

2017-12-20 14:21

On December 12, Huahai Pharmaceutical announced that the ANDA of "pregabalin capsules" declared to the US FDA has been temporarily approved (temporary approval: FDA has completed the safety and effectiveness review of generic drugs, but because the patent or monopoly has not expired and given a form of approval).

The basic situation of drugs:

1. Drug Name: Pregabalin Capsules

2. ANDA No.: 207883

3. Dosage form: Capsule

4. Specifications: 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg

5. Application Items: ANDA (Brief Application for New Drugs in the United States)

6. Applicant: Pulin Stone Pharmaceutical Co., Ltd. (Prinston Pharmaceutical, Inc.)

Up to now, Huahai Pharmaceutical has invested about 6.5 million yuan in the research and development project of pregabalin capsules.

Original drug information:

Pregabalin capsules, developed by Pfizer and primarily for the treatment of post-herpetic neuralgia, were marketed in the United States in 2005. In the United States, the manufacturer of pregabalin capsules is currently Pfizer; the current domestic manufacturers are Chongqing Saiwei Pharmaceutical Co., Ltd. According to statistics, in 2016, the sales volume of pregabalin capsules in the US market was about 4.3 billion US dollars, and the sales volume in the domestic market was about 0.174 billion yuan. The original research enterprise compound patent expires on December 30, 2018.

At present, Pfizer has applied for relevant preparation patents for pregabalin sustained-release tablets in the United States and China, namely US20060555988 and CN 200680041140.7. The sustained-release formulation is very different from the solid pharmaceutical composition described in CN 200680041140.7, in that the excipient in the CN 200680041140.7 comprises a matrix forming agent comprising polyvinyl acetate and polyvinyl pyrrolidone and a swelling agent comprising crosslinked polyvinyl pyrrolidone. The excipient in the sustained-release preparation mainly comprises a swelling agent and a skeleton material, the swelling agent comprises polyoxyethylene and crosslinked polyvinylpyrrolidone, and the skeleton material comprises sodium alginate.