USA — Viatris Pharmaceuticals is currently awaiting regulatory verdicts on its generic versions of the widely used type 2 diabetes drug Ozempic and the breakthrough weight loss treatment Wegovy.
If approved, these generics would mark significant milestones as the first alternatives to hit the market for these blockbuster medications.
However, Novo Nordisk, the pharmaceutical giant behind Wegovy, has taken preemptive action to halt Viatris’ plans to introduce a generic version of Wegovy.
Novo filed a lawsuit in a Delaware District Court in January, citing Viatris’ submission of an abbreviated New Drug Application (NDA) to the FDA for a generic injection of Wegovy prior to the expiration of its patents.
Novo claims that the submitted NDA essentially mimics Wegovy’s label and formulation, and argues that it will suffer irreversible damage if Viatris is allowed to infringe on these patents.
In its legal pursuit, Novo seeks a permanent injunction against patent infringement and potential damages should the generic version be commercialized.
Viatris, alongside Mylan, refutes these allegations of patent infringement, asserting its intent to secure FDA approval for semaglutide injections across various doses, ranging from 0.25 mg to 2.4 mg, in single-dose prefilled pens.
The genesis of Viatris traces back to a monumental US$12 billion merger between Mylan and Pfizer’s Upjohn unit in 2020.
However, this consolidation has not shielded Viatris from legal confrontations with Novo Nordisk. In a previous agreement, Viatris committed not to introduce a generic variant of Victoza (liraglutide), another type 2 diabetes drug, until June 2024.
The spotlight remains on Viatris as it endeavors to bring 13 complex injectables, including Wegovy and Ozempic generics, to market.
This ambitious endeavor is projected to culminate in an estimated US$1 billion in annual peak net sales by 2027.
Addressing these developments, Viatris President Rajiv Malik hinted at a potential timeline for product launches, stating, “We should be looking into launching these products, if we are optimistic, later this year or early next year.
“From then onwards, I think every year, you will see two to three key products getting launched.”
In a recent move, Viatris unveiled its generic version of AstraZeneca’s prominent asthma and Chronic obstructive pulmonary disease (COPD) drug, Symbicort, which garnered a substantial US$2.5 billion in revenue for the pharma giant in 2022.
Viatris partnered with Kindeva Drug Delivery to introduce its inhalant Breyna, an intricate drug-device combination that marks a noteworthy entry into the competitive landscape of Symbicort generics.
Beyond these pursuits, Viatris is also collaborating with Mapi Pharma and has submitted an Abbreviated New Drug Application (ANDA) to the FDA for a once-monthly, long-acting glatiramer acetate injection aimed at treating relapsing forms of multiple sclerosis.
A decision from the FDA is anticipated by March 8, 2024, adding yet another dimension to Viatris’ quest for innovative pharmaceutical solutions.
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