On 23 September 2026, Mylan filed a Complaint in the US District Court for the District of Delaware seeking a declaration of non-infringement and invalidity in relation to Novo Nordisk’s U.S. Patent No. 12,551,536. The patent was granted on 17 February 2026 and relates to a method for reducing body weight by subcutaneous administration of 2-10 mg semaglutide weekly.
Mylan has filed an abbreviated new drug application (ANDA) with the FDA (on an unidentified date) seeking approval to market semaglutide prefilled single dose pens. In its Complaint, Mylan alleges that it has a reasonable apprehension that Novo Nordisk will sue Mylan for infringement of the US ‘536 patent. This is on the basis that the US ‘536 patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) for Wegovy®, but Novo Nordisk did not initiate litigation concerning that patent within 45 days of receiving a notice on 17 June 2026 stating Mylan believes no valid claim of the US 536 patent will be infringed by exploitation of its generic semaglutide product.
Mylan claims the US ‘536 patent is invalid on a number of grounds, including lack of novelty and obviousness and asks the Court to declare that the exploitation of Mylan’s generic semaglutide products will not infringe the ‘536 patent.
Novo Nordisk has previously sued Mylan for infringement of a number of US semaglutide patents, including in 2023 (five patents, including US 9,764,003), 2024 (US 12,029,779) and 2025 (US 12,214,017). On 22 July 2025, the US District Court in Delaware ruled on the pleadings that Mylan did not induce infringement of the US ‘003 method of treatment patent in connection with its generic Wegovy® products.
Novo Nordisk has US patent infringement litigation pending against a number of other companies, including Apotex, Cipla and Sun Pharma, in relation to their generic semaglutide products.
Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.