Generic liraglutide: what FDA approval means

Approvals so far

The first GLP-1 generic of any kind was an exenatide injection referencing Byetta®, approved on 19 November 2024 ^[2]. A month later FDA approved Hikma’s liraglutide injection, 18 mg/3 mL, as the first generic of Victoza® for blood sugar control in type 2 diabetes in adults and children aged 10 and older ^[1]. FDA’s list of first generics for 2025 records Teva’s liraglutide referencing Saxenda® on 27 August 2025, for weight reduction and maintenance alongside a reduced-calorie diet and more physical activity ^[3].

More approvals followed. The table lists every generic liraglutide application in the Orange Book data file published on 9 October 2026, with the brand each one is rated against ^[4]. All of them are on the prescription list rather than the discontinued list. An approval does not tell you whether a pharmacy has stock; FDA’s own press release asked readers to contact the manufacturer about availability ^[1].

Two brands, one molecule, two codes

Victoza® and Saxenda® both contain liraglutide, injected once a day, and liraglutide has an elimination half-life of about 13 hours ^[11]. The two labels describe different uses and dose ranges. Victoza® is for type 2 diabetes in adults and children aged 10 and older, with a maximum of 1.8 mg a day, and it is also indicated to lower the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease ^[10]. Saxenda® is for weight management at 3 mg a day, and its label says liraglutide has not been shown to be effective for weight reduction at doses below 3 mg ^[11].

Both pens hold the same 18 mg/3 mL solution, which is why the Orange Book needs a way to separate them. Its preface explains the system with tablet examples coded AB1 and AB2: when one heading has more than one reference drug of the same strength, a number is added to the code, a generic gets the number of the brand it was tested against, and products with such a code count as equivalent only to products carrying the same code ^[5]. The liraglutide entries follow that pattern, with Victoza® itself coded AP1 and Saxenda® AP2, so a generic coded AP1 is rated against Victoza® and one coded AP2 against Saxenda® ^[4].

Neither brand label allows combining liraglutide with another liraglutide product, and Saxenda® extends that to any other GLP-1 receptor agonist ^[10][11].

What FDA requires of a generic

According to FDA, a generic must have the same active ingredient, strength, dosage form and route of administration as its brand, along with the same label information and instructions, with certain exceptions ^[7]. The maker files an abbreviated new drug application showing that the product is pharmaceutically equivalent and bioequivalent to the brand it references, and that it can be produced consistently ^[8].

Generic makers do not repeat the brand’s animal and clinical studies, one reason generics usually cost less ^[7]. FDA says generics approved this way are generally considered therapeutically equivalent to their brand, so the same clinical effect and safety profile are expected ^[8].

Why a GLP-1 generic took time

FDA calls liraglutide a complex product: the active ingredient, the formulation and the injection device all make a generic harder to develop than a simple tablet, and many complex drugs have no generic competition ^[1]. In the same announcement FDA described its guidance documents and pre-application programme as ways of making such generics more feasible ^[1].

Patents and periods of marketing exclusivity also decide when a generic can be sold ^[7]. When FDA announced the first Victoza® generic, it noted that liraglutide was in shortage and that it prioritises generic applications for drugs in shortage ^[1].

Shortage entries and the end of brand Saxenda®

The shortage has not been closed. In FDA’s database, liraglutide injection is listed as a current shortage, first posted on 18 July 2023, with entries updated in September and October 2026 ^[6]. Both Victoza® presentations are marked as limited availability because of a delay in shipping, while several generic presentations, including Hikma’s, are marked as available ^[6].

Two entries concern discontinuation. Novo Nordisk lists Saxenda® as to be discontinued: manufacture is ending and, according to the entry, the product will be available until January 2027 ^[6]. One Teva liraglutide presentation has also been listed as to be discontinued since 14 May 2026 ^[6]. These are company notices to FDA, not safety actions. What a discontinuation means for a particular prescription is a question for the prescriber and pharmacist.

Same warnings, possibly a different look

Because a generic carries the brand’s label information, it carries the same boxed warning about thyroid C-cell tumours and the same contraindications: a personal or family history of medullary thyroid carcinoma, MEN 2, or a past serious allergic reaction to liraglutide ^[7][10]. The Victoza® Medication Guide also covers pancreatitis, low blood sugar when used with insulin or a sulfonylurea, dehydration and kidney problems, severe stomach problems, serious allergic reactions and gallbladder problems ^[10].

FDA generally allows minor differences in appearance between a generic and its brand, such as colour ^[8]. Inactive ingredients may differ too; FDA says this usually does not matter, although in a minority of people they can affect tolerability or absorption ^[8]. With an injection pen, the device and its instructions for use may differ from the brand, so it is worth reading the generic’s own instructions and asking a pharmacist to go through them.

Generic is not compounded

The two words are often confused. A generic is approved by FDA under its own section of federal law after establishing therapeutic equivalence to a brand. A compounded drug is prepared by a pharmacy or outsourcing facility and is not FDA-approved ^[9].

FDA’s compounding question-and-answer page states this directly: compounded drugs and generic drugs are not the same ^[9]. FDA also points people to the Orange Book to check whether a generic version exists ^[8], and the pharmacy label tells you the manufacturer of what you were given.

If your pen or maker changes

A refill can come from a different maker than the one before, especially while some presentations are in short supply ^[6]. Each pen has its own instructions for use, and the Victoza® label sets out a restart rule after a gap of more than 3 days, so any interruption is worth raising with the prescriber ^[10].

FDA asks people who think a medicine is not working or is causing a problem to talk to their doctor or pharmacist and to consider reporting it through FDA’s SmartHub, even when they are not sure the drug was the cause ^[8]. Having the maker’s name and lot number to hand makes such a report more useful.

Victoza® and Saxenda® are registered trademarks of Novo Nordisk A/S. Byetta® is a trademark of the AstraZeneca group of companies. PepLabo is not affiliated with or endorsed by Novo Nordisk, AstraZeneca or any generic manufacturer named here.

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