"Transfer" the heart failure drug ENTRESTO's imitation of Novartis is accused of infringement

"Transfer" Novartis, who is busy prosecuted with heart failure drug Entresto, is accused of infringement

Source: Same freehand

Recently, Novartis, who has been sued by other homes, has become the "attack target" of others. The center of the vortex is Entresto, a drug that Nuohua treats heart failure.

The lawsuit comes from the University of Michigan and the University of South Florida. They alleged that Entresto violated a common crystal patent they held. On Monday, the two universities filed a lawsuit with the District Court of the North District of California.

The lawsuit pointed out the patent No. 10633344 awarded by the United States in April 2020. According to the complaint, this patent includes a multi -component solid drug with a multi -component solid drug with "improved drug solubility, dissolving rate, stability and biological utilization".

The University of Michigan and the University of South Florida believe that ENTRESTO communist crystals include "super molecular synthesis" and involve super molecular technology in patents.

ENTRESTO is a sodium symbolic composite composite combined with Sakubabe and Tshadartan. It is the first vascular tension body-cerebral fungin enzyme inhibitor (ARNI) drug. The vascular tensionase conversion enzyme (ACE) inhibitors in the first test of the head -to -head test that can significantly reduce mortality can be significantly reduced. Compared with the existing heart failure drugs, it has obvious treatment advantages.

In July 2015, Entresto was approved for the first time for the treatment of patients with ejection scores to reduce heart failure (HFREF). In February last year, the FDA approved Entresto to expand for patients with ejection scores to retain HFPEE patients. ENTRESTO became the first and only drug approved for two types of heart failure indications (HFREF and HFPEF).

Entresto was approved in China in 2017. The first indication was heart failure. In June last year, Entresto was approved by NMPA for the treatment of primary hypertension. At present, ENTRESTO is used to treat HFREF and hypertension. Both indications have been included in the national medical insurance directory and come into effect since January 2022.

Thanks to Entresto's preferred treatment for HFREF and most HFPEF patients, this "heavy bomb" drug is rapidly seizing the market.

Last year, ENTRESTO created a sales of $ 3.55 billion, ranking second in Nuohua's best -selling drug. In the first half of this year, ENTRESTO jumped to the top of the Nuohua drug sales list with sales of US $ 2.218 billion, an increase of 37 % year -on -year, becoming Novarton's best -selling drug and major growth momentum.

ENTRESTO has a strong growth rate. Novartis has expected that the annual peak sales of the drug will exceed $ 5 billion. Entresto's various patents will expire in 2036. In order to extend the life cycle of this fist product as much as possible, Novartis is busy prosecuting several Entresto generic drug competitors including Teva, Viatris, Aurobindo and Lupin to accuse these of these. The drug violates Entresto's patented formula.

In order to "protect their rights", Novartis also submitted a citizen's petition at the end of 2021, asking the FDA to not approve any Entresto generic drugs by at least in February 2024. At that time, Novartis pointed out that at least 18 pharmacies submitted the application to seek FDA to approve Entresto's generic drugs. These companies hope to push their generic drugs to the market in July 2023.

However, in the face of the allegations of the University of Michigan and the University of South Florida, Novartis did not respond immediately.

In addition, Nohua, who was involved in the lawsuit, was involved in the bribery scandal. The Greek Minister of Health Thanos Plevris announced in June that he claimed a lawsuit against Novartis and asked the other party to compensate 214 million euros for the "bribery doctors recognized in the United States".

In addition to the need to be "outer", Novartis also ran around in "Anno".

In mid -August, Novartis announced in Switzerland to reduce 1,400 employees and plans to achieve overall changes in the next few months. Coincidentally, Novartis announced recently that it plans to completely peel off its imitation drugs and biological similar pharmaceutical departments, and the latter will become a newly listed independent operating company, which will complete the split process as soon as the second half of next year. Many people in the industry said that this is related to the continuous revenue of Sam Dushi for many years and the pressure of generic drugs.

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