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On April 22, the listing application for the new four-category generic drug "Varenicline Tartrate" by Hausen Pharmaceuticals entered the approval status, and it is expected to be approved soon, becoming the first domestic imitation of this product.
The Insight database shows that currently only Pfizer's "Varenicline Tartrate Tablets" (trade name: Changpei) was approved for import in 2008 (manufacturer: R-Pharm Germany GmbH), and the indication is for adults to quit smoking.
Varenicline is a selective partial agonist of the nicotinic acetylcholine receptor α4β2 subtype and has a high affinity for this receptor in nerves.
At present, the first-line drugs for treating tobacco dependence are divided into two categories.
Nicotine-containing drugs, namely nicotine replacement therapy, contain a variety of dosage forms, such as patches, chewable preparations, inhalants, nasal sprays, sublingual tablets, etc.
In addition, some drugs are second-line drugs for nicotine treatment, such as clonidine, nortriptyline, nicotine vaccine, etc.
According to the Insight database, Varenicline's global sales in 2019 reached US$1.
Insight data shows that Hausen is the first domestic company to submit a listing application for varenicline tartrate tablets, and is expected to win the first imitation of this variety.
