An analogue of Ozempic went on sale despite the patent

The fact that the Danish Novo Nordisk has a patent for the popular drug for controlling glucose levels “Ozempic” did not prevent the appearance of a local analogue of the drug in pharmacies. Sales of “Quincenta” released by Promomed began in several chains in Moscow and St. Petersburg. Only Novo Nordisk itself can ban the circulation of generics, but it will probably be more profitable for the company to reach an agreement with manufacturers of analogues, experts say.

The Promomed company’s drug for controlling sugar levels, semaglutide, under the brand name “Quincenta”, appeared in the pharmacies “Zdorov.ru” and “Fialka” in Moscow and St. Petersburg, Kommersant discovered on the online display windows of these pharmacies. According to AptekaMos.ru, “Quincenta” can also be purchased at REDapteka in Moscow and “People’s Pharmacy” in St. Petersburg. The cost of “Quincenta” is from 5.65 thousand to 5.7 thousand rubles. per package.

“Quincenta” went on sale despite the presence of a patent for the original “Ozempic” in the Russian Federation, which is valid until 2035. Promomed told Kommersant that they are in correspondence with Novo Nordisk and, in parallel with providing patients with vital drugs, are resolving legal aspects. Novo Nordisk declined to comment.

Another analogue of semaglutide under the brand name Semavica is being prepared for sale by Geropharm. The first three series of this drug were put into circulation on December 11, according to data from Roszdravnadzor. “Geropharm” in the fall turned to the government with a request for a compulsory license, said the general director and co-owner of the company Pyotr Rodionov. The company offered Novo Nordisk to start producing Ozempic at its facilities, but did not receive a response. Geropharm told Kommersant that Semavik will go on sale after the government’s decision on compulsory licensing.

The Ministry of Industry and Trade told Kommersant that the mechanism for issuing a compulsory license “requires careful application” to maintain a balance of interests of manufacturers and patients.

As a representative of the Ministry of Industry and Trade recalled, companies have the right to demand a compulsory license through the court, citing insufficient use of the patent. According to the file of arbitration cases, as of December 15, no such applications had been received.

As part of the government order, analogues of semaglutide have been purchased since November, as follows from the information on the government procurement website. According to Kommersant’s calculations, by December 14, the regions had signed contracts for the supply of Semavik or Quicenta for 147.2 million rubles. Contracts for 52.9 million rubles. are at the signing stage. Some agreements limit delivery to the end of 2023. There are no completed contracts yet.

Alexey Mikhailov, head of patent practice at the Patentus bureau, says that only the manufacturer of the original medicine, if it is under patent protection, can obtain a ban on the sale of a generic through the court. DSM Group CEO Sergei Shulyak points out that if Novo Nordisk goes to court, it may receive a counterclaim for compulsory licensing due to non-use of the patent. In his opinion, it may be more profitable for the Danish company to negotiate with Promomed and Geropharm on the sale of generics under certain conditions.

Polina Gritsenko