Generic Liraglutide (Victoza) Becomes First Generic GLP-1 Receptor Agonist

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Teva Pharmaceuticals’ launch of an authorized generic of liraglutide injection 1.8 mg (Victoza) for type 2 diabetes makes it the first-ever generic GLP-1.

Victoza liraglutide injection | Credit: Victoza

Credit: Victoza

Teva Pharmaceuticals has announced the launch of an authorized generic of liraglutide (Victoza) in the United States for patients with type 2 diabetes, making it the first-ever generic glucagon-like peptide-1 (GLP-1) receptor agonist.1

“By launching an authorized generic for Victoza® (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, SVP, Head of US Commercial Generics at Teva, said in a press release.1 “In addition to strengthening Teva's diverse complex generics portfolio, we are providing the first generic GLP-1 product to the U.S. marketplace, demonstrating once again our ability to sustain a generics powerhouse.”

According to the American Diabetes Association, in 2021, 38.4 million people in the US, or 11.6% of the population, had diabetes, with an estimated 1.2 million new diabetes diagnoses every year. The total cost of diabetes in the US in 2022 was estimated to be $412.9 billion, including $306.6 billion attributed to direct medical costs and $106.3 billion attributed to indirect costs, underscoring the need for low-cost, effective medications to address the growing incidence and financial burden.2

Liraglutide was first approved by the US Food and Drug Administration (FDA) in 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. In 2017, a new indication was approved to reduce the risk of major adverse cardiovascular events, heart attack, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.3,4

The decision was based on results from the landmark LEADER trial demonstrating that liraglutide’s significant reduction in the risk of a three-component endpoint consisting of cardiovascular death, non-fatal heart attack, or non-fatal stroke by 13% versus placebo (P = .01) with an absolute risk reduction (ARR) of 1.9%. Additionally, treatment with liraglutide resulted in a 22% reduction in cardiovascular death (ARR, 1.3%) and a 15% reduction in all-cause death (ARR, 1.4%).4

In 2019, liraglutide received FDA approval for the treatment of type 2 diabetes in pediatric patients 10 years of age or older, making it the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Its efficacy and safety for reducing blood sugar in patients with type 2 diabetes was studied in several placebo-controlled trials in adults and a single placebo-controlled trial with 134 pediatric patients 10 years of age and older for > 26 weeks. Results showed approximately 64% of patients in the pediatric study had a reduction in their hemoglobin A1c below 7% while on liraglutide, compared to 37% who achieved these results with placebo.4

In 2017, Teva filed an abbreviated New Drug Application with the FDA, seeking approval to market the generic version of Novo Nordisk’s liraglutide injection. In 2019, Teva and Novo Nordisk reached a settlement on the US patent litigation case for liraglutide, allowing Teva to launch a generic version of liraglutide beginning March 22, 2023, unless the liraglutide patents were no longer in force or another generic version of liraglutide was marketed.5,6

According to a release from Teva, liraglutide had annual sales of $1.656 billion as of April 2024.1

References:

  1. Teva Announces Launch of Authorized Generic of Victoza® (liraglutide injection 1.8mg), in the United States. June 24, 2024. Accessed June 24, 2024. https://www.businesswire.com/news/home/20240623654311/en/Teva-Announces-Launch-of-Authorized-Generic-of-Victoza%C2%AE-liraglutide-injection-1.8mg-in-the-United-States
  2. American Diabetes Association. Statistics About Diabetes. Accessed June 24, 2024. https://diabetes.org/about-diabetes/statistics/about-diabetes
  3. FDA Approves Novo Nordisk's Victoza for Adults With Type 2 Diabetes. HCPLive. January 26, 2010. Accessed June 24, 2024. https://www.hcplive.com/view/novo_nordisk_victoza_diabetes
  4. Drugs.com. Victoza FDA Approval History. June 17, 2019. Accessed June 24, 2024. https://www.drugs.com/history/victoza.html
  5. Teva Pharmaceuticals. Teva Confirms Generic Victoza® Patent Challenge in the United States. February 2, 2017. Accessed June 24, 2024. https://www.tevausa.com/news-and-media/press-releases/teva-confirms-generic-victoza-patent-challenge-in-the-united-states/
  6. Novo Nordisk. Novo Nordisk settles US patent litigation case on Victoza® (liraglutide) with Teva. March 18, 2019. Accessed June 24, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=414#
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