Novo Nordisk has commenced Hatch-Waxman litigation in the US against both Cipla and Apotex in relation to their generic versions of Novo Nordisk’s semaglutide products.
Most recently, on 17 July 2026, Novo Nordisk filed a Complaint against Cipla in the US District Court for the District of New Jersey alleging that Cipla’s generic version of Novo Nordisk’s Ozempic® (semaglutide) infringes four US patents which cover Ozempic® and/or its use: US 8,129,343, US 10,335,462, US 12,295,988 and US 12,569,543. The complaint arises from Cipla’s submission of an Abbreviated New Drug Application (ANDA) seeking approval to market generic Ozempic® in dosage strengths of 2 mg/3ml, 4 mg/3ml and 8 mg/3ml.
Novo Nordisk had previously commenced litigation in the same Court against Apotex on 10 October 2024 in relation to generic Rybelsus® (semaglutide), on 20 February 2026 in relation to generic Ozempic® tablets® and on 29 April 2026 in relation to generic Wegovy® (semaglutide). Orders were made by the Court on 12 June 2026 consolidating the three actions. Apotex received the first US FDA Tentative Approval for its generic Ozempic® ANDA in April 2026, signifying that Apotex’s product meets all statutory and regulatory requirements for approval but cannot be marketed in the US because of patents or exclusivities related to the reference drug.
Novo Nordisk also has patent litigation pending in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan in relation to generic Wegovy®, which was commenced in September 2024.
Meanwhile, on 21 July 2026, Novo Nordisk filed a false advertising lawsuit against Eli Lilly in the US District Court for the District of New Jersey, alleging that Eli Lilly’s nationwide, direct-to-consumer advertising campaigns for GLP-1 medicines are designed to mislead the public about the comparative effects of those medicines for weight loss and type 2 diabetes.
Novo Nordisk claims that Eli Lilly’s ads falsely tell consumers that Zepbound® (tirzepatide) helps patients lose significantly more weight than Novo Nordisk’s Wegovy® and that Eli Lilly’s Mounjaro® (tirzepatide) reduces a key measure of blood sugar control for type 2 diabetes patients significantly more than Novo Nordisk’s Ozempic®. According to Novo Nordisk, in both cases, the ads are false and misleading because Eli Lilly seeks to support its representations with outdated clinical trials that compare the highest dose of Zepbound®/Mounjaro® to lower doses of Novo Nordisk’s medicines, when there are newer, more effective does of Novo Nordisk’s products available.
Novo Nordisk is seeking preliminary and permanent injunctions preventing Eli Lilly from continuing to disseminate the comparative advertising, as well as damages and corrective advertising.