MSN Laboratories Pvt Ltd.

Novartis is trying to do everything possible to keep a generic version of its blockbuster heart failure drug Entresto off the U.S. market. Despite numerous legal hurdles, the company has failed to gain regulatory approval. In the process, U.S. District Judge Dabney Friedrich made clear in an order issued Tuesday that the Food and Drug Administration (FDA) did not overstep its authority when it approved MSN Pharmaceuticals to make a generic version of Entresto, despite slight and alleged discrepancies in the labeling of the two drugs. Novartis said in a statement that it disagreed with the ruling and had decided to appeal. MSN Pharmaceuticals and the FDA were not immediately available for comment. Entresto is one of Novartis' top-selling drugs, bringing in more than $6 billion in revenue last year alone. A generic version of Entresto, made by MSN Pharmaceuticals, received FDA approval last month, marking the first generic version of the drug on the market in the United States. Novartis had previously filed a separate patent infringement lawsuit against MSN Pharmaceuticals and lost in August to block the launch of a generic version of MSN. Still, MSN Pharmaceuticals is barred from launching its generic version because Novartis appealed the order. Shortly after the FDA approved MSN Pharmaceuticals' application to sell a generic version of Entresto, Novartis filed a lawsuit against the FDA in July, claiming that the approval was arbitrary and capricious and violated the Federal Food, Drug, and Cosmetic Act (FDCA) in multiple ways. However, as the case moved forward, Judge Dabney Friedrich rejected Novartis's claim that the FDA's approval was based on its reasonable interpretation of the federal Food, Drug, and Cosmetic Act, rather than following the FDA's opinion. Novartis also argued that MSN Pharma's generic version is not exactly the same as Entresto because it is a simple mixture of two active ingredients, rather than linking two molecules together in a crystal structure. However, Judge Friedrich noted that under FDA's long-standing guidance, "different physical forms do not preclude proof of the same active ingredient," and stressed the authority of FDA's scientific judgment. Notably, the background to this case is a lawsuit between Novartis and MSN Pharmaceuticals, case No. 1:24-cv-02234, U.S. District Court for the District of Columbia. Novartis was represented by Susan Cook, Kathryn Stetson and Marlan Golden of Hogan Lovells, while the FDA was represented by Gabriel Schonfeld of the U.S. Department of Justice. MSN Pharmaceuticals is represented by Polsinelli Law firm, including Chad Landmon, Suzanne Bassett, Corey Casey and Kendall Gurule. Despite Novartis' legal attempts to block MSN Pharma's generic from entering the market, the judge's ruling shows that the FDA's approval was based on sound legal and scientific grounds, and Novartis' road to appeal remains challenging.

Novartis first sued MSN and a clutch of other drugmakers over plans to approve generics to Entresto back in 2022. The company claims infringement of the so-called ‘918 patent, which is set to expire in November 2026. After seeking to block the launch of MSN Pharmaceuticals’ recently approved Entresto generic, Novartis has hit a snag in its multiyear crusade to thwart copycats of its top-selling heart failure drug.Monday, Delaware District Judge Richard Andrews rejected Novartis’ infringement claims against MSN and denied the Swiss Pharma’s bid for an injunction on the generic maker’s launch. MSN received FDA approval for its Entresto generic July 24, according to court documents published (PDF) this week.Novartis first sued MSN and a clutch of other drugmakers over plans to approve generics to Entresto back in 2022. The company claims infringement of the so-called ‘918 patent—set to expire in November 2026—which covers the amorphous solid form of a compound in Entresto, according to the court documents.To hear Andrews tell it, “Novartis bears the burden of proof, both on infringement and on showing likelihood of success.” That said, the judge argued that Novartis “has not met the burden it bears at this stage” regarding MSN’s alleged infringement. Aside from the infringement claim, Novartis has also argued it will suffer irreparable harm if MSN is allowed to launch its heart failure copycat.“As an initial matter, I am skeptical about Novartis’ characterization of its many harms,” the judge wrote in his decision.In particular, Novartis has contended that an at-risk launch by MSN would kick off a wave of generic Entresto rollouts by other drugmakers, “thereby destroying Entresto’s market momentum” and causing lost sales, lost market share, loss of formulary position and price erosion.In rejecting Novartis’ request for an injunction, Andrews said he didn’t find it “reasonable” to attribute harm from other companies’ actions to MSN’s launch of its own product. Additionally, the judge thought it was unfair to blame MSN for the “impaired promotion” of Novartis’ other cardiovascular drugs, which he argued would result from Novartis’ own “profit-maximizing business decision to decrease its cardiovascular products salesforce in response to MSN’s launch.”While Andrews blocked the request for an injunction, he granted a three-day stay to provide time for Novartis to appeal the decision.In a statement provided to Reuters, Novartis said it’s now “considering all available options” and will maintain its financial guidance for the year.Beyond the Delaware case, Novartis earlier this month filed a lawsuit against the FDA in federal court in Washington, D.C., arguing that the regulator’s decision to approve MSN’s generic was unlawful.The Swiss pharma specifically alleged that the FDA’s conduct was unlawful because it promotes labeling that “inappropriately rewrites Entresto’s approved indication.” Novartis further argued that MSN’s label for its copycat medicine “deletes critical safety information contained in the Entresto labeling.”During its latest earnings call, Novartis said it currently expects Entresto generics to hit in mid-2025, though the company is defending against that possibility on multiple patent fronts in a bid to extend Entresto’s market exclusivity.Entresto is also one of 10 meds up for Medicare price negotiations under 2022’s Inflation Reduction Act. The negotiated prices are set to be announced Sept. 1 and will go into effect in 2026. Despite being approved almost a decade ago, Entresto continues to generate major cash for Novartis.As the company’s best-selling drug, Entresto brought home a little over $6 billion in global sales last year. Over the first half of 2024, the medicine has generated sales of nearly $3.8 billion. 

Novartis' attempts to prevent MSN Pharmaceuticals from launching a generic version of its blockbuster heart failure drug, Entresto, have once again failed. First approved in 2015, Entresto is a heart failure medication that improves heart function in people with specific heart conditions. The drug generated $4.64 billion in 2022. Its exclusivity was extended with an approval for HFpEF in 2021, and there are still no approved generic versions available. This week, a Delaware judge dismissed Novartis' patent infringement claims and denied their request to block MSN's generic from entering the market. While Novartis argued that MSN's generic infringes on its patent, the judge ruled that Novartis did not demonstrate a strong likelihood of success in proving this. The court also found that Novartis had not shown it would suffer "irreparable harm" if the generic launched. The court dismissed MSN's request to strike some of Novartis' evidence since it wasn't necessary to rule on it. However, the judge gave Novartis 72 hours to appeal the decision before any changes take effect. Despite this challenge, Novartis is exploring its legal options and has also filed a lawsuit against the FDA, arguing that the approval of MSN's generic was unlawful. The agency responded last month, explaining that its decision centers on the balance between fostering pharmaceutical innovation and ensuring the availability of affordable generic drugs. In its statement, the FDA outlined drug approval pathways under the FD&C Act, highlighting the 505(b)(1) NDA, which requires full safety and efficacy reports, and the 505(j) ANDA, which facilitates generic approvals based on existing data. The FDA rejected Novartis' request to block ANDA approvals for Entresto during its exclusivity period, clarifying that exclusivity does not indefinitely prevent generic competition. Additionally, the FDA addressed labeling carve-outs, allowing generics to omit patented uses while ensuring the drug remains safe and effective for non-patented indications.