Novartis Wins UK Court Backing in Lawsuit Over Entresto Patent Validity

Novartis said London’s High Court rejected Accord Healthcare’s challenge to invalidate Novartis’ Entresto patent and supplementary protection certificate, finding the planned generic would infringe. Accord, a unit of Intas Pharmaceuticals, had planned a later 2026 launch. Entresto contributes about 10% of Novartis sales. Similar results occurred in the Netherlands, while Novartis lost a US bid last year.

A London court upheld Novartis’ extended patent protections for Entresto, a heart failure drug, blocking Accord’s plans to launch a generic version in the near term, according to the court ruling described in the article. The decision affects the timing of generic competition for Entresto.

The FDA issued a nationwide Class II recall of Diovan (valsartan) 160 mg tablets after one lot (AV5913C) failed dissolution specifications, meaning the tablets may not dissolve properly and could reduce effectiveness. Novartis initiated the recall Aug. 4. The affected product expires June 2027 and was made by Patheon and distributed by Novartis.

The FDA issued a Class II urgent recall of valsartan (Diovan) due to failure to meet dissolution specifications, which may reduce effectiveness and cause temporary or medically reversible adverse health consequences. The affected batch (AV5913C) includes 90-count 160 mg tablets expiring June 2027, distributed nationwide by Novartis. Novartis initiated the recall Aug. 4.

The FDA says Novartis recalled one lot of Diovan (valsartan) due to failed dissolution specifications, meaning tablets may not dissolve correctly. The affected product is 160 mg, 90-count bottles, lot AV5913C, exp. June 2027. The recall began Aug. 4 and was later classified Class II. Manufacturing was by Patheon Manufacturing Services.

The FDA said Novartis Pharmaceuticals recalled Diovan (valsartan) 160 mg, 90-tablet bottles nationwide due to failed dissolution specifications, meaning tablets did not meet required dissolution standards. The recall is Class II. It covers lot AV5913C (exp. June 2027) manufactured by Patheon and distributed by Novartis.