Liraglutide Patent Litigation Case Settled

Novo Nordisk and Teva Pharmaceuticals USA, Inc. have reached settlement on patent litigation over liraglutide (Victoza®, Novo Nordisk),¹ a noninsulin medication for type 2 diabetes (T2D).²

As a result of the agreement, Teva is licensed to launch a generic version of the drug as of December 22, 2023, according to Novo Nordisk.¹

Liraglutide (Victoza): A Quick Guide for Pharmacists

In today’s settlement announcement by Novo Nordisk, company officials said that under certain circumstances Teva could launch a comparable generic liraglutide medication earlier, but not before March 22, 2023, unless the Victoza^® patents are no longer in force or there is another generic version on the market. If Novo Nordisk is granted a 6 months pediatric extension for its established liraglutide product, other mentioned timelines will be extended by 6 months.¹

All other terms of the settlement are confidential, and the agreement is subject to review by the US Federal Trade Commission and the US Department of Justice.¹

"This settlement reflects the comprehensive US patent portfolio for liraglutide. Novo Nordisk will continue to defend our broad intellectual property portfolio for innovative drugs against challenges," Jesper Brandgaard, executive vice president and head of Biopharm and Legal Affairs of Novo Nordisk, explained in a prepared statement.¹

In addition to lowering blood sugar and reducing AIC, liraglutide is used for reducing the risk of major cardiovascular events, such as heart attack, stroke, or death, in individuals with T2D who are being treated for cardiovascular disease.^2-3

Comorbidities and Cardiovascular Disease with T2DM

Novo Nordisk's liraglutide injection was Initially approved by the FDA in 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with T2D. It's use was expanded with FDA approval in 2017 for cardiovascular disease in patient with T2D.³

The most common adverse events associated with the use of liraglutide include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.³

References

• Novo Nordisk settles US patent litigation case on Victoza® (liraglutide) with Teva [news release]. Bagsværd, Denmark; March 18, 2019: Novo Nordisk website. https://www.novonordisk-us.com/media/news-releases.html?122957. Accessed March 18, 2019.
• Novo Nordisk. Considering Victoza. Victoza website. http://www.pharmacytimes.com/link/261. September 2018. Accessed March 18, 2019.
• Barrett J. FDA Approves Diabetes Drug Indication to Reduce CV Risk. Pharmacy Times. https://www.pharmacytimes.com/product-news/fda-approves-diabetes-drug-indication-to-reduce-cv-risk. Published August 25, 2017. Accessed March 18, 2019.