Novartis NVS recently suffered another setback in its attempt to block the entry of a generic version of its blockbuster heart drug Entresto.
On Aug 12, judge Richard Andrews of The United States District Court For The District Of DelaWare denied Novartis' motion for preliminary injunction against MSN Pharmaceuticals Inc., MSN Laboratories Private Limited and MSN Life Sciences Private Limited for the launch of a generic version of Entresto.
Several generic manufacturers are looking to launch a generic version of the drug.
In October 2022, Novartis filed a complaint alleging infringement of U.S. Patent No. 11,096,918 by MSN and several other defendants. This patent covers the amorphous solid form of a compound (TVS) present in Entresto that consists of sacubitril, valsartan and sodium cations. The patent is set to expire on Nov 8, 2026.
In July 2024, MSN received final FDA approval for its abbreviated new drug application for Entersto. Per Reuters, MSN's version of Entresto would be the first generic of the drug in the United States.
Consequently, Novartis moved for a preliminary injunction to prevent the prospective launch of MSN's generic sacubitril/valsartan product.
Novartis argued that it will suffer significant losses if MSN is allowed to launch its generic as it will also trigger launches by several other generic drugmakers, thereby destroying Entresto's market momentum and causing irreparable harm in the form of lost sales, lost market share, loss of formulary position and price erosion.
The judge stated that Novartis is unlikely to succeed in proving infringement of the patent.
Nonetheless, Novartis’ request for a stay to allow it to seek injunctive relief from the Federal Circuit was granted. MSN was also instructed to not sell its generic for 72 hours while Novartis appeals to the U.S. Court of Appeals for the Federal Circuit.
Entresto, one of the top-selling drugs for Novartis, raked in sales of $6 billion in 2023. On its second-quarter conference call, NVS stated that it expects entry of Entresto generics in mid-2025.
An earlier-than-expected generic entry for Entresto can be detrimental to Novartis. In August 2023, Entresto was also selected for the Medicare Drug Price Negotiation Program in the United States.
Novartis’ performance in the second quarter was impressive as both earnings and sales beat estimates. Based on strong momentum, NVS raised its core operating income guidance.
The company is now focused on strengthening its core pharmaceutical business with strategic acquisitions and deals. The recent MorphoSys acquisition should further expand its oncology pipeline.
NVS also entered into an exclusive strategic license agreement with a clinical-stage biotechnology company, Arvinas, Inc. ARVN, for the worldwide development and commercialization of the latter’s pipeline candidate, ARV-766.
ARV-766 is Arvinas’ second-generation PROTAC androgen receptor degrader. The candidate complements NVS’ RLT platform in prostate cancer.
However, Novartis’ decision to discontinue its phase II/III program on KRAS G12C inhibitor, opnurasib, for the treatment of non-small cell lung cancer (NSCLC) to prioritize other key programs in the portfolio, was met with a lukewarm response by investors.
Novartis’ decision to discontinue also gives an edge to competitors like Roche RHHBY, Amgen and Bristol Myers.
Roche, another Swiss drugmaker, is evaluating KRAS G12C inhibitor, divarasib, for the treatment of second-line NSCLC.
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