Novo Nordisk has at least four more years to build up its newer diabetes drugs before they'll have to compete with Teva's knockoff versions of its own blockbuster Victoza.
Under a new patent settlement (PDF) with the Israel-based generics giant, Novo wouldn't face Victoza copies until the end of 2023, and if Novo wins pediatric exclusivity from the FDA, the copycat rollout will push that off to June 2024.
That gives Novo time to grow its weekly GLP-1 drug Ozempic, approved in late 2017 as a follow-up to the daily Victoza, and its forthcoming oral version of the same drug, before those newer medications have to face Victoza generics. Novo is hoping to get oral semaglutide to the FDA within weeks for an approval by year's end.
Novo has a lot riding on its new generation of GLP-1 drugs as payer pressure puts a damper on sales and rival drugs in the class—namely Eli Lilly's Trulicity—shave away at Victoza's market share. Victoza brought in $2.67 billion last year, up 8% over 2017. Ozempic sales reached nearly $273 million last year.
Teva and Novo's tentative patent settlement allows the generics maker to launch on Dec. 22, 2023. If Victoza’s patent portfolio falls to another generic challenger or if another generic hits the market sooner, Teva would be able to launch before that date. Teva could launch after March 22, 2023, under other undisclosed circumstances.
If Novo scores a pediatric extension for its drug, the dates would be moved back by 6 months. The U.S. Department of Justice and Federal Trade Commission must sign off on the deal.
In a statement, Jesper Brandgaard, Novo EVP and head of biopharma and legal affairs, said the company will “continue to defend our broad intellectual property portfolio for innovative drugs against challenges.”
Teva has been challenging Novo’s patents and pushing to launch its own version of Victoza since at least 2017. In February of that year, Teva said it filed an FDA application for a Victoza copycat and that it believed it was a “first filer,” which would come with 180 days of generic exclusivity.
Novo hit back in an FDA petition in October 2017, asking the agency to force generics companies to put Victoza copycats through clinical testing. In its petition, Novo said the “complexity of the recombinant-derived liraglutide product and its efficacy and safety is specifically tied to the manufacturing process.” The FDA rejected the petition a few months later.
Under Monday’s settlement, market watchers will have more clarity on when to expect Victoza generics. It isn't clear whether any other companies have filed for FDA approval of their own Victoza knockoffs.
While Novo works to grow sales for Ozempic, the company plans to file for approval of the oral version of semaglutide by the end of the first quarter. The drugmaker plans to use a priority review voucher for the application and the drug could win U.S. approval by the end of the year, analysts with financial group ODDO BHF wrote.
Analysts believe the oral option will disrupt the increasingly competitive diabetes market, grow the entire GLP-1 class and pull in blockbuster sales.
For Teva, the deal means the company will have to wait years for the revenue boost that would come with launching a Victoza generic. The company has been suffering from lower generic pricing in the U.S. for years, and has also recorded big Copaxone sales declines due to generic launches. Teva last month laid out 2019 guidance lower than analysts had expected.
With those factors considered, Teva is counting on new migraine launch Ajovy to contribute sales growth. Meanwhile, the company has a restructuring effort underway aimed at saving $3 billion annually. The company plans to close or sell 11 manufacturing facilities this year.