Teva Launches Generic Formulation of Liraglutide in US

Teva announced the launch of the generic formulation of liraglutide (Victoza; Novo Nordisk) in the United States, marking the first launch of a generic glucagon-like peptide 1 receptor agonist. It is approved for the use along with diet and exercise to lower blood sugar in adults and children aged 10 and older with type 2 diabetes (T2D). Additionally, it is approved to reduce the risk of major adverse cardiovascular events, including heart attack, stroke, and death for those with T2D and known heart disease.¹

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The generic formulation is in the 1.8 mg injection strength, with Victoza having an annual sale of 1.656 billion as of April 2024, according to a news release.¹

“By launching an authorized generic for Victoza (liraglutide injection 1.8mg), we are providing patients with [T2D] another option for this important treatment,” Ernie Richardsen, SVP and head of US Commercial Generics at Teva, said in the news release. “In addition to strengthening Teva's diverse complex generics portfolio, we are providing the first generic GLP-1 product to the US marketplace, demonstrating once again our ability to sustain a generics powerhouse.”¹

Victoza was first approved in 2010 as an adjunct therapy to diet and exercise for the improvement of blood sugar, with the cardiovascular indication being added in 2017. Liraglutide was approved for cardiovascular outcomes following the LEADER (NCT01179048) trial, which showed the rate of first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (the primary end point) for patients with T2D who were treated with Victoza.^2,3

There were 9340 individuals included in the study who had a median follow-up of 3.8 years. There were 608 of 4668 cases of the primary outcome for the Victoza group compared to the placebo (694 if 4672) Fewer patients in the Victoza group died from cardiovascular cases at 4.7% compared to the placebo at 6% and rate from death of any cause was 8.2% and 9.6%, respectively. The most common adverse events (AEs) leading to discontinuation included gastrointestinal events.The most common AEs associated with the use of liraglutide included nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.^3,4

In 2019, Novo Nordisk and Teva Pharmaceuticals reached a settlement on patent litigations for liraglutide, licensing Teva to launch the generic version of the medication. The settlement allowed Teva to launch the generic medication in December 2023.⁴

In 2019, Victoza was approved for the treatment of pediatric individuals aged 10 and older with T2D, making it the first noninsulin drug to be approved for pediatrics since metformin in 2000. Due to the approval, the timeline of the generic launch was delayed by 6 months.^4,5

The abbreviated new drug application was initially filed in 2017 and was the first applicant to file for the generic version of Victoza, according to the company.⁶

References

1. Teva Announces Launch of Authorized Generic of Victoza (liraglutide injection 1.8mg), in the United States. News release. Teva Pharmaceuticals. June 24, 2024. Accessed June 27, 2024. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-launch-of-authorized-generic-of-victoza-liraglutide-injection-1.8mg-in-the-united-stat/?utm_source=hootsuite&utm_medium=linkedin&utm_term=teva+pharmaceuticals&utm_content=c71289f4-dfd2-4505-8819-1604d051e3a6&utm_campaign=

2, Drugs.com. Victoza FDA Approval History. June 17, 2019. Accessed June 27, 2024. https://www.drugs.com/history/victoza.html

3. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016;375(4):311-322. doi:10.1056/NEJMoa1603827

4. Coppock K. Liraglutide Patent Litigation Case Settled. Pharmacy Times. March 18, 2019. June 27, 2024. https://www.pharmacytimes.com/view/liraglutide-patent-litigation-case-settled

5. Pharmacy Times. Liraglutide Approved for Pediatric Patients with Type 2 Diabetes. June 17, 2019. Accessed June 27, 2024. https://www.pharmacytimes.com/view/liraglutide-approved-for-pediatric-patients-with-type-2-diabetes

6. Teva Confirms Generic Victoza Patent Challenge in the United States. News release. February 02, 2017. Accessed June 27, 2024. https://www.tevausa.com/news-and-media/press-releases/teva-confirms-generic-victoza-patent-challenge-in-the-united-states/