What Happened to Byetta and Bydureon? Both Brands Discontinued
AstraZeneca discontinued Byetta on Oct. 25, 2024 and Bydureon BCise on Oct. 28, 2024. FDA approved a generic twice-daily exenatide injection on 11/19/2024, though it cautions that approved drugs are not always available on the approval date.
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Yes, both brand-name exenatide products are discontinued in the United States. AstraZeneca notified the FDA that it discontinued Byetta on Oct. 25, 2024, and Bydureon BCise on Oct. 28, 2024 [5]. Separately, the FDA published a notice on 08/04/2025 withdrawing approval of 39 new drug applications from multiple applicants — all products the applicants said were no longer marketed — with the withdrawal effective September 3, 2025 [1]. The available text of that notice does not identify which 39 applications were withdrawn, so it does not confirm whether the exenatide applications were among them [1].
If you took Byetta or Bydureon BCise, the brand-name versions are no longer marketed. Exenatide itself still has an approved product in the United States: FDA approved a generic twice-daily exenatide injection, Exenatide Injection USP, on 11/19/2024, though FDA notes that approved drugs are not always available on or after the listed approval date [6]. What any individual patient switches to is a prescriber decision, and insurers have already published lists of preferred covered alternatives [5].
Is Bydureon BCise discontinued permanently?
Bydureon BCise was discontinued on Oct. 28, 2024, according to a UnitedHealthcare provider notice dated December 19, 2024, which reports that AstraZeneca notified the FDA of the discontinuation [5]. Byetta was discontinued three days earlier, on Oct. 25, 2024 [5].
No announcement of a return appears in the discontinuation notice or the FDA records cited here [5] [1].
Was the FDA withdrawal a safety action?
No. The FDA notice published on 08/04/2025 withdrew approval of 39 new drug applications from multiple applicants [1]. The stated reason is that the applicants told the agency in writing that the drug products were no longer marketed, and asked that approval be withdrawn [1]. The notice presents no safety or effectiveness finding against the products — all 39 applications were withdrawn through the same process for the same stated reason [1].
One important limitation: the available text of the notice does not identify which applications were withdrawn. The affected applications appear in a table within the notice, and the portion of that table available in the cited source does not show any exenatide entry, so the source does not confirm that Byetta or Bydureon were among the 39 [1].
What does the withdrawal mean legally?
The mechanism was a voluntary one. The applicants requested withdrawal under the process in 21 CFR 314.150(c), and by making that request they waived their opportunity for a hearing [1]. The withdrawal took effect September 3, 2025 [1].
The notice is cited as 90 FR 36440, Docket No. FDA-2025-N-2422, document 2025-14683 [1]. A correction notice to the same docket was published on 10/03/2025 [1]. A withdrawal under this section is without prejudice to refiling, meaning an applicant is not barred from submitting the application again [1].
Where did exenatide come from?
The active ingredient traces back to exendin-4, a peptide isolated from the venom of the Gila monster, Heloderma suspectum [2].
The early laboratory work was done in rat pancreatic acini — cells from rat pancreas studied in vitro, not in humans. In that system, exendin-4 caused roughly a 3-fold increase in cAMP but did not change cellular calcium concentration [2]. The cAMP effect was blocked by an exendin-receptor antagonist, exendin(9-39)NH2, but not by VIP-receptor antagonists [2]. On its own, exendin-4 up to 1 microM did not release amylase; when exendin-4 at concentrations greater than 30 pM was combined with cholecystokinin, amylase release was potentiated [2].
How did once-weekly exenatide compare with liraglutide head-to-head?
The main head-to-head study was DURATION-6, a 26-week open-label randomized study run at 105 sites in 19 countries between January 11, 2010 and January 17, 2011 [3]. Of 912 patients randomized, 911 were included in the intention-to-treat analysis: 450 on liraglutide 1.8 mg once daily and 461 on exenatide 2 mg once weekly by subcutaneous injection [3].
Liraglutide lowered HbA1c more. The least-squares mean change was -1.48% with liraglutide versus -1.28% with exenatide [3]. The treatment difference was 0.21% (95% CI 0.08–0.33), which did not meet the predefined noninferiority criterion — the study required the upper limit of the confidence interval to be below 0.25%, and it was not [3].
| Measure | Liraglutide 1.8 mg daily | Exenatide 2 mg weekly |
|---|---|---|
| HbA1c change (least-squares mean) | -1.48% | -1.28% |
| Nausea | 93 (21%) | 43 (9%) |
| Diarrhea | 59 (13%) | 28 (6%) |
| Vomiting | 48 (11%) | 17 (4%) |
| Stopped study drug for adverse events | 24 (5%) | 12 (3%) |
The gastrointestinal side effects ran the other way: nausea, diarrhea, and vomiting were all less frequent in the exenatide group, and their incidence decreased over time in both groups [3]. The study was funded by Eli Lilly and Company and Amylin Pharmaceuticals LLC and is registered as NCT01029886 [3].
What did the EXSCEL cardiovascular trial find?
EXSCEL randomly assigned 14,752 patients with type 2 diabetes, with or without previous cardiovascular disease, to extended-release exenatide 2 mg once weekly or matching placebo [4]. Of those, 10,782 (73.1%) had previous cardiovascular disease, and median follow-up was 3.2 years (interquartile range 2.2 to 4.4) [4].
The primary composite outcome — death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke — occurred in 839 of 7,356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group versus 905 of 7,396 (12.2%; 4.0 per 100 person-years) in the placebo group [4]. The hazard ratio was 0.91 (95% CI 0.83–1.00), with P<0.001 for noninferiority for safety but P=0.06 for superiority — in other words, exenatide was not shown to be better than placebo at preventing major cardiovascular events [4].
There were no significant between-group differences in cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure, acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, or serious adverse events [4]. The trial was funded by Amylin Pharmaceuticals and is registered as NCT01144338 [4].
Is there a generic version of Byetta?
Yes. FDA’s 2024 first-generic approvals page lists Exenatide Injection USP, ANDA 206697, from applicant Amneal EU, Limited, approved on 11/19/2024 [6]. It references the brand listed drug Byetta Injection, NDA 021773 [6]. Its approved indication is as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus — a diabetes indication, not weight loss [6].
One caveat FDA attaches to its first-generic listings: approved drugs are not always available on or after the listed approval date, and the agency directs people to contact the ANDA applicant for availability information [6].
For comparison, the first generic liraglutide injection, ANDA 215503 from Hikma Pharmaceuticals USA, referencing Victoza, was approved on 12/23/2024 [6].
Is a generic weekly exenatide listed on FDA’s 2024 first-generics page?
No. FDA’s 2024 first-generic approvals page shows no first-generic listing for a once-weekly extended-release exenatide product [6]. The only exenatide first generic listed on that page is the twice-daily injection referencing Byetta [6].
Which GLP-1s do insurers prefer after the discontinuation?
UnitedHealthcare, in its December 19, 2024 provider notice on the discontinuations, listed preferred covered GLP-1 alternatives by plan type [5]:
| UnitedHealthcare plan | Preferred covered GLP-1s |
|---|---|
| Commercial plans | Mounjaro, Ozempic, Rybelsus, Trulicity, liraglutide (Victoza authorized generic) |
| Individual Exchange / ACA Marketplace plans | Mounjaro, Ozempic, Rybelsus, Trulicity |
| Community Plans | State-specific drug lists |
| Medicare Advantage and stand-alone Part D plans | Check member-specific coverage through PreCheck MyScript |
This is one insurer’s list, and preferred products vary by plan type and by insurer [5]. It shows what payers did with the discontinuation — the manufacturer’s FDA notification flowed into payer formulary notices — not what any particular patient should take [5] [1].
Where can you check current exenatide availability and pricing yourself?
Two federal tools track what is actually on the market. DailyMed and the FDA NDC directory show current labeling and listed products for exenatide [11] [12].
For pricing, Medicaid’s NADAC — the National Average Drug Acquisition Cost — publishes weekly reference data on data.medicaid.gov [7]. The 2026 dataset was updated September 8, 2026, and the full file is downloadable as a CSV [7]. Each row carries the NDC description, NADAC per unit, effective date, pricing unit, and generic or brand classification [7].
NADAC reflects what pharmacies pay to acquire the drug, not what a patient pays out of pocket [7].
What is the status of exenatide research in Parkinson’s disease?
Exenatide has also been studied for Parkinson’s disease. A phase 3, multicenter, double-blind, parallel-group, randomized, placebo-controlled trial of once-weekly exenatide was run at six research hospitals in the UK, aiming to test whether exenatide slows Parkinson’s disease progression [8]. The rationale came from neurotrophic effects in in-vitro and in-vivo models, plus epidemiological studies and small randomized trials [8].
That trial’s record now carries an Expression of Concern from the Editors of The Lancet (Lancet 2026 Jun 27;407(10548):2588, epub 2026 Jun 22, PMID 42330995) [8] [9]. An Expression of Concern is not a retraction, and the record shows no retraction [8] [9]. A related registration, NCT04232969, covers exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson’s disease [10].
What should someone who took Byetta or Bydureon do now?
The brand-name products are discontinued [5]. A generic twice-daily exenatide injection was approved on 11/19/2024, though FDA notes approved drugs are not always available on the approval date [6].
Choosing a replacement is a prescriber decision, and what insurance covers depends on the plan: preferred GLP-1 lists differ between commercial, Marketplace, Community, and Medicare plans, as the UnitedHealthcare notice shows [5]. Current product availability can be checked on DailyMed and the FDA NDC directory [11] [12].
Sources
- Federal Register. Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications. August 4, 2025.
- PubMed. Exendin-4, a new peptide from Heloderma suspectum venom, potentiates cholecystokinin-induced amylase release from rat pancreatic acini.
- PubMed. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study.
- PubMed. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.
- UnitedHealthcare Provider Resources. Discontinuation of Bydureon BCise and Byetta. December 19, 2024.
- US Food and Drug Administration. 2024 First Generic Drug Approvals.
- Medicaid.gov. NADAC (National Average Drug Acquisition Cost) 2026. Updated September 8, 2026.
- PubMed. Exenatide once a week versus placebo as a potential disease-modifying treatment for people with Parkinson’s disease in the UK: a phase 3, multicentre, double-blind, parallel-group, randomised, placebo-controlled trial.
- PubMed. Expression of Concern: Exenatide once a week versus placebo as a potential disease-modifying treatment for Parkinson’s disease in the UK: a phase 3 trial.
- ClinicalTrials.gov. Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson’s Disease. Study NCT04232969.
- DailyMed. Search Results for exenatide.
- openFDA. Drug National Drug Code (NDC) directory API data.
Frequently asked questions
Is Byetta still available in the US in 2026?
The brand-name product is not. AstraZeneca discontinued Byetta on Oct. 25, 2024. A generic version, Exenatide Injection USP from Amneal EU, Limited, was approved on 11/19/2024 for type 2 diabetes, though FDA cautions that approved drugs are not always available on the approval date.
Is Bydureon BCise discontinued permanently or coming back?
Bydureon BCise was discontinued on Oct. 28, 2024. A generic twice-daily exenatide injection was approved on 11/19/2024.
Was the FDA withdrawal because the drug was unsafe?
No. The FDA notice published 08/04/2025 withdrew approval of 39 applications because the applicants told FDA in writing that the products were no longer marketed and requested withdrawal. The notice presents no safety or effectiveness finding. The withdrawal was effective September 3, 2025. The available text does not identify which applications were withdrawn, so it does not confirm the exenatide products were among them.
Is there a generic version of Byetta and who makes it?
Yes. FDA's 2024 first-generic approvals page lists Exenatide Injection USP, ANDA 206697, from applicant Amneal EU, Limited, approved 11/19/2024, referencing Byetta Injection (NDA 021773). The approved indication is improving glycemic control in adults with type 2 diabetes, as an adjunct to diet and exercise.
Is a generic weekly exenatide listed on FDA's 2024 first-generics page?
No. FDA's 2024 first-generic approvals page shows no first-generic listing for a once-weekly extended-release exenatide product. The only exenatide first generic listed on that page is the twice-daily injection referencing Byetta.
What drugs can replace Bydureon BCise?
That is a prescriber decision. As an example of what payers did, UnitedHealthcare's December 19, 2024 notice lists preferred covered GLP-1s by plan type — including Mounjaro, Ozempic, Rybelsus, Trulicity, and liraglutide (Victoza authorized generic) for its commercial plans. Lists vary by plan and insurer.
Which GLP-1s does insurance prefer after the discontinuation?
It depends on the plan. UnitedHealthcare's commercial preferred list is Mounjaro, Ozempic, Rybelsus, Trulicity, and liraglutide (Victoza authorized generic); its Marketplace list drops liraglutide; Community Plans use state-specific lists and Medicare plans use PreCheck MyScript.
How did exenatide compare with liraglutide head-to-head?
In the 26-week DURATION-6 study, HbA1c fell -1.48% with liraglutide 1.8 mg daily versus -1.28% with exenatide 2 mg weekly, and exenatide missed the predefined noninferiority bar. Nausea was 21% with liraglutide versus 9% with exenatide.
This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.