Saxenda is the oldest GLP-1 approval for weight management in the US — December 2014, seven years before Wegovy — and the only daily injection among them. It has since been overtaken by weekly drugs, generic copies of it have reached pharmacies, and Novo Nordisk has told FDA that one of its packs will stop being made. This page reads what the records say about all three, as of 5 October 2026.
It is built from the Saxenda prescribing information revised in February 2026 (read on DailyMed), FDA's Drugs@FDA records and approval letters, the Orange Book product file and FDA's drug shortage database. Strengths and the daily titration schedule are outside this page; Peptifact reports them on its liraglutide dosage page.
What it is approved for
The label approves Saxenda "in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term" in:
| Who | Condition | Added |
|---|---|---|
| Adults | obesity | 23 December 2014 |
| Adults | overweight with at least one weight-related comorbid condition | 23 December 2014 |
| Children aged 12 and older | obesity, and body weight above 60 kg | 4 December 2020 (supplement 12) |
Indications from section 1 of the February 2026 label; dates from Drugs@FDA and FDA's approval letter for supplements 12–14.
Two limits are written into the label. Saxenda should not be combined with other liraglutide products or any other GLP-1 drug, and its "safety and effectiveness … in pediatric patients with type 2 diabetes have not been established". The February 2026 revision also removed the label's section on suicidal behaviour and ideation — a removal FDA requested for all three GLP-1 weight-management labels, recorded on our GLP-1 and depression page.
What liraglutide is, and why it is daily
Liraglutide is "97% homologous to native human GLP-1", made by attaching a 16-carbon fatty acid (palmitic acid) to the peptide through a glutamic-acid spacer; its molecular weight is 3,751.2 Da. The label explains the difference that matters most to a user: native GLP-1 has a half-life of 1.5 to 2 minutes, liraglutide "has a plasma half-life of 13 hours", which "makes it suitable for once-daily administration". Semaglutide, with a longer fatty chain, lasts about a week. The family tree is on semaglutide vs liraglutide and the mechanism on how GLP-1 works.
What the trials on the label found
| Label trial (56 weeks) | People | Saxenda | Placebo | Lost ≥5% (Saxenda vs placebo) |
|---|---|---|---|---|
| Study 1 — obesity or overweight with a condition, no diabetes | 3,731 | −7.4% | −3.0% | 62.3% vs 34.4% |
| Study 2 — type 2 diabetes with obesity or overweight | 635 | −5.4% | −1.7% | 49% vs 16.4% |
| Study 3 — after losing ≥5% on a diet run-in | 422 | −4.9% | +0.3% | 44.2% vs 21.7% |
Table 4 of the February 2026 label. Study 3 counts weight change from randomisation, after a diet that had already removed at least 5%; the label warns its results "may not reflect those expected in the general population".
Placebo-adjusted, the main trial's difference is 4.5 percentage points. The label also records how many people stopped: 27% of Saxenda users and 35% of placebo users across the 56-week trials, and about 10% against 4% because of an adverse reaction. How those figures compare with the weekly drugs' trials is on the best GLP-1 for weight loss.
One warning is specific to the daily drug's record: resting heart rate rose by 2 to 3 beats per minute on average in adults, and 34% of Saxenda users against 19% on placebo had rises of more than 10 bpm at two consecutive visits. In the adolescent trial, increases of 3 to 7 bpm were seen. The rest of the label's warnings — the thyroid C-cell boxed warning, pancreatitis, gallbladder disease, low blood sugar with diabetes drugs, kidney injury from dehydration, severe gastrointestinal reactions, hypersensitivity and aspiration under anaesthesia — match the class and are summarised on GLP-1 side effects.
Generic liraglutide: which copies are Saxenda
Liraglutide was the first GLP-1 molecule to go generic, and the Orange Book now lists eleven generic products. All share Saxenda's 18 mg/3 mL strength, so the strength alone does not say which brand a generic replaces. The therapeutic-equivalence code does:
| Code | Equivalent to | Generic makers (approval date) |
|---|---|---|
| AP2 | Saxenda (weight) | Teva (27 Aug 2025) · Biocon, ANDA 217063 (24 Feb 2026) · Orbicular, ANDA 217234 (24 Feb 2026) |
| AP1 | Victoza (type 2 diabetes) | Hikma (23 Dec 2024) · Nanjing King-Friend (2 Apr 2025) · Lupin (22 Jul 2025) · Orbicular (14 Jan 2026) · Biocon (11 Mar 2026) · Fresenius Kabi (30 Mar 2026) · Mylan Institutional (15 Jun 2026) · Sandoz (1 Jul 2026) |
Orange Book product file dated 11 September 2026. Biocon and Orbicular each hold one approval under each code.
So there are, by FDA's own coding, three generic Saxendas, the first approved in August 2025, and eight generic Victozas. FDA's shortage database lists one Teva liraglutide pack as "To Be Discontinued" from 14 May 2026. What a generic GLP-1 means for the newer brands is on when will Ozempic go generic?.
The discontinuation notice and the shortage record
Liraglutide entered FDA's drug shortage database on 18 July 2023 and has not left it. On 5 October 2026 the database held "Current" entries for Saxenda, Victoza and generic liraglutide from Hikma and Meitheal, among others.
The newer entry is a different kind. On 25 August 2026 FDA's database added a "To Be Discontinued" record for Saxenda's five-pen pack (NDC 0169-2800-15), giving the reason "Discontinuation of the manufacture of the drug" and the note: "Product will be available until discontinuation in January 2027." The ongoing shortage entry for the same pack was re-verified on 22 September 2026 with the availability "Limited Availability" and the same January 2027 note.
What the record does not say is as important. It names one package; the label lists two, a three-pen pack (NDC 0169-2800-13) and the five-pen pack, and no entry mentions the three-pen pack. It says nothing about the approval itself, which remains active in Drugs@FDA, and it does not say whether the brand as a whole will be withdrawn. Anyone using Saxenda and affected by a pack change has the prescriber and pharmacist to ask; the shortage entry lists the company's contact number.
How people get it
Saxenda and its generics are prescription-only. Coverage for weight-management drugs follows the label and is often excluded; the rules are on GLP-1 insurance coverage, and the class's prices on what GLP-1 drugs cost.
Sources
Saxenda (liraglutide) injection prescribing information, revised 02/2026, DailyMed set 3946d389-0926-4f77-a708-0acb8153b143 · Drugs@FDA application record for NDA 206321 via openFDA · FDA approval letters for NDA 206321 supplements 4 and 6 (2017-04-26), 7 (2018-10-19), 11 (2020-03-25) and 12–14 (2020-12-04) · FDA Orange Book product file dated 11 September 2026 · FDA drug shortage database, liraglutide entries, via openFDA. All read 5 October 2026.