“Pharmasintez” introduced into circulation the first three series of the drug “Nooredit” based on phenylpiracetam

Pharmasyntez Vikram Punia received from Valenta Pharm the rights to use the patent for phenylpiracetam and is bringing the drug Nooredit to the market with this active substance. This is an analogue of the well-known drug for improving brain activity, Phenotropil, the rights to which are now owned by Valenta Pharm. Previously, the drug occupied 9% of the entire nootropics segment. But now, as experts note, it has lost its position, since it has not been produced for almost five years.

On October 18, Pharmasyntez put into circulation the first three series of the drug Nooredit based on phenylpiracetam, and found “Kommersant” in the Roszdravnadzor register. This is an analogue of Phenotropil, owned by Valente Pharm, prescribed for diseases of the nervous system and depression, but more often used to improve brain activity, for example, by schoolchildren and students during exams. Pharmasyntez told Kommersant that the maximum price for Nooredit will become known after its registration. Valente Pharm declined to comment.

According to DSM Group, in January-September 2023, drugs based on phenylpiracetam were sold in pharmaceutical retail for 695 million rubles, which is a 29% increase year-on-year. The largest share, about 70%, was accounted for by Phenotropil, another 17.2% by the generic of the same Valenta Pharm Nanotropil Novo, 12.6% by Actitropil from Pharmstandard.

Valenta Pharm produced Phenotropil in 2004–2017 under an agreement with the rights holders of the drug, Valentina and Roman Akhapkin. The discontinuation of production was initiated by Mrs. Akhapkina, who decided to independently develop the drug. But it failed to set up production, like other pharmaceutical companies that planned to organize the production of their generics based on phenylpiracetam. Such attempts have been made, for example, by Kanonpharma Production, Mosmedpreparaty, and the Israeli Teva.

In 2020, Pharmstandard managed to invalidate Valentina Akhapkina’s patent for phenylpiracetam at Rospatent. She lost her cases in all courts. This allowed Pharmstandard to launch production of its generic Actitropil.

A year later, Valenta Pharm obtained through the court an early termination of the protection of the Phenotropil trademark, which was registered in the name of Roman Akhapkin. Valenta Pharm resumed production of the original Phenotropil in 2022, almost five years after its production ceased.

However, in 2022, Pharmasyntez began to challenge Valenta Pharm’s patent for this drug in Rospatent, but there is no decision on the challenge in the department’s register. The parties managed to reach an agreement, notes Alexey Mikhailov, head of patent practice at Patentus. He refers to the fact that in February 2023, Pharmasyntez entered into a licensing agreement with Valenta Pharm. From the materials of Rospatent it follows that Bratskkhimsintez, part of Vikram Punia’s group, also received a license; the substance for Nooredit will be produced there.

While there was controversy surrounding fonturacetam in general and Phenotropil in particular, the drug managed to lose its position in the market. According to RNC Pharma, before the rights holders broke off relations with Valenta in 2017, Phenotropil accounted for 9.1% in rubles of total sales in the nootropics segment, and at the end of nine months of 2023 – already 4.2% . Now drugs based on phenylpiracetam are actually re-conquering the market, but taking into account the availability of analogues, notes Nikolai Bespalov, development director at RNC Pharma.

Sales of nootropic drugs in January-September decreased in rubles by 1.9%, to 12.2 billion rubles. The leaders among drugs used for diseases of the nervous system, according to RNC Pharma, are drugs based on glycine and aminophenylbutyric acid – they account for almost 49% in money.

DSM Group CEO Sergei Shulyak believes that Pharmasyntez can contribute to the growth of sales of phenylpiracetam, taking into account the fact that the company is not limited in production capacity. Akrikhin is also preparing its own generic version of Phenotropil (they declined to comment), which received permission to conduct bioequivalence studies in October.

Polina Gritsenko