Lupin announced approval of Lirglutide ANDA

On 24 July, Lupin announced that it has received approval from the USFDA for its ANDA for Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials. Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza® Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk Inc. It is indicated as an adjunct to diet and exercise to improve glycemic control. Lupin stated in the press release that Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen (RLD Victoza®) had an estimated annual sale of USD 458 million in the U.S. (IQVIA MAT May 2025). There are two other approved products in the US market. Sandoz has settled the case and is likely awaiting approval from the FDA. Teva is in the market with Authorised Generics.


Lupin is likely using Hybio API. Details of Lupin’s recent import are as follows.

One may notice the API is being imported at USD 441/gram, and those following liraglutide API prices can observe a substantial price drop for the API in commercial quantities. The formulation prices in the US vary based on several factors, making it difficult to obtain an exact idea from publicly available prices. However, indicative prices are listed below.
Lupin’s price for US patients may be comparable to or lower than Meitheal/Nanjing. The API's contribution to the FDF price may be insignificant.


Location: Mumbai, Maharashtra, India

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