Teva launches authorized generic of Victoza, the first generic GLP-1 sold in the U.S.

Teva Pharmaceuticals announced on June 24, 2024 that it had started selling an authorized generic of Victoza, liraglutide injection 1.8 mg, in the United States ^[1][3]. The company called the product the first generic GLP-1 to reach the U.S. market ^[1][2].

An authorized generic is sold under the brand manufacturer's existing approval rather than through a separate application. Victoza is a registered trademark of Novo Nordisk ^[1].

Victoza brought in $1.656 billion in annual sales as of April 2024, according to IQVIA figures Teva cited in its announcement ^[1]. The trade publication Drug Discovery and Development reported launch list prices of $469.60 for a two-pack and $704.40 for a three-pack ^[2].

"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," said Ernie Richardsen, senior vice president and head of U.S. commercial generics at Teva ^[1]. A Teva spokesperson told Drug Discovery and Development that the company hopes the launch will help improve access and address some current challenges, and said Teva expects to bring its first-to-file generic of Saxenda to market "at the appropriate time" without giving a date ^[2].

What liraglutide is approved to do

The label covers two uses: helping control blood sugar in adults and children age 10 and older with type 2 diabetes, and lowering the risk of major cardiovascular events such as heart attack, stroke or death in adults who have type 2 diabetes plus established heart disease ^[1]. The 1.8 mg product is not for people with type 1 diabetes and should not be combined with other medicines containing liraglutide ^[1]. Saxenda, a separate liraglutide product, is the one indicated for weight loss ^[2].

Liraglutide is a different molecule from semaglutide, which is sold as Ozempic, Wegovy and Rybelsus, and from tirzepatide, sold as Mounjaro and Zepbound. Liraglutide's patent had been scheduled to expire on November 18, 2024, while semaglutide keeps patent protection until 2026, according to Drug Discovery and Development ^[2].

The labeling carries a boxed warning that liraglutide caused thyroid C-cell tumors in rats and mice, and that it is not known whether it causes medullary thyroid carcinoma in people ^[1]. It is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. Other listed risks include pancreatitis, low blood sugar, acute kidney injury, serious allergic reactions, gallbladder disease and pulmonary aspiration during general anesthesia or deep sedation ^[1][4]. Common side effects include nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation ^[1]. Injection pens should never be shared between people, even with a new needle ^[4].

Why it matters for patients

People with type 2 diabetes who take liraglutide now have a lower-priced alternative to the brand, and this is the first time that has been possible for any GLP-1 in the U.S. ^[1][2].

The launch does not create a generic version of semaglutide or tirzepatide. Ozempic, Wegovy and Rybelsus, and Mounjaro and Zepbound, remain brand-only products ^[2]. Because liraglutide injection 1.8 mg is not indicated for weight loss, this product is not a substitute for the GLP-1 medicines people use for weight management ^[1][2].

List price is not the same as what a patient pays at the counter. How insurers will cover the generic, what pharmacies will charge, and how its price compares with brand Victoza have not been disclosed in the launch announcements ^[1][3].

What happens next

Teva has said it will bring a generic version of Saxenda to market at an appropriate time, without specifying when ^[2]. The liraglutide patent was set to lapse on November 18, 2024, which opened the door to further competition ^[2].

On December 26, 2024, Hikma Pharmaceuticals said it had received FDA approval and launched its own generic liraglutide injection at a 6 mg/mL strength in the U.S. ^[4]. Hikma cited IQVIA data showing U.S. sales of liraglutide injection 6 mg/mL of about $1.3 billion in the 12 months ending October 2024 ^[4]. No generic version of semaglutide has been announced, and its patent protection runs to 2026 ^[2].