Novo Nordisk files patent claims to fend off generic rivals
Sun Pharma of India and Mylan Pharmaceuticals of West Virginia seek FDA approval of generic versions of the popular weight-loss drug. Novo Nordisk says the efforts infringe on its patent.
Novo Nordisk filed complaints this week against two pharmaceutical companies that are seeking approval to develop generic versions of its patented Wegovy product for weight loss.
The separate complaints, one against Sun Pharmaceutical Industries of India and another against Mylan Pharmaceuticals of West Virginia, were filed Thursday in the U.S. District Court for the District of Delaware by Brian Egan and Travis Murray of Morris, Nichols, Arsht & Tunnell. Counsel for the defendants has not appeared.
Novo Nordisk Inc., based in Plainsboro, New Jersey, is a subsidiary of Novo Nordisk A/S, headquartered in Denmark.
According to the complaints, both Sun Pharma and Mylan have filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration for approval of generic versions of Wegovy, a semaglutide injection that improves various health conditions by helping patients lose weight.
Novo Nordisk is the only company in the United States with FDA-approved products containing semaglutide, available by prescription under the trade names Wegovy, Ozempic and Rybelsus, according to a 2024 statement from the company.
Shares of Novo have soared some 230% since the company launched Wegovy in June 2021, Reuters reported last month. Strong demand for Wegovy and other weight loss drugs have created shortages for some patients, according to UCHealth.
Novo Nordisk has served more than 1 million U.S. patients and “will do our best” to support patients, according to a statement on its website, “but it is important to recognize that overall demand will continue to exceed supply. This means that some patients will still have difficulty filling their prescriptions.”
The company said it is increasing its manufacturing capacity and, in June, announced its plan to invest $4.1 billion to build a facility in Clayton, North Carolina, to produce treatments for people with obesity and other chronic diseases.
The Abbreviated New Drug Application, or ANDA, process was part of the “Drug Price Competition and Patent Term Restoration Act” of 1984, which allowed pharmaceutical companies to have a faster process for the approval of generic versions of existing drugs.
Related: Making the case for Wegovy coverage: Drug keeps weight off for 4 years, aids heart health
According to the complaints, Novo Nordisk contends efforts by Sun Pharma and Mylan to develop generic versions of Wegovy would violate its U.S. Patent No. 12,029,779. According to the company’s annual report, the patent will not expire until 2032.
Novo Nordisk contends each defendant’s proposed ANDA product “is not a staple article of commerce and has no substantial approved uses that do not infringe” on the ’779 patent, according to the complaint.
“Novo Nordisk will be irreparably harmed” if the defendants are not enjoined from infringing on the patent, it said.
The company has asked for rulings that find the defendants to have infringed on the ’779 patent and that FDA approval not be awarded until expiration of the patent.