Byetta, the first GLP-1 receptor agonist, is off the U.S. market

Byetta (exenatide), the injectable that opened the GLP-1 receptor agonist class in the United States, is no longer being sold. AstraZeneca discontinued Byetta on Oct. 25, 2024, and discontinued the longer-acting, once-weekly version, Bydureon BCise, on Oct. 28, 2024, after notifying the FDA ^[2]. No reason for either discontinuation has been reported ^[2]. The original FDA approval date and application number for Byetta have not been disclosed in the records cited in this article.

Both products were GLP-1 receptor agonist drugs used to treat diabetes ^[2]. The discontinuations removed the two exenatide products from the U.S. market. Whether any generic or other exenatide product remains available has not been reported.

In a notice to providers dated Dec. 19, 2024, UnitedHealthcare said it had identified preferred covered alternatives so that patients with UnitedHealthcare benefit plans would keep access to a covered GLP-1 receptor agonist for diabetes ^[2]. The covered alternatives depend on the plan:

• Commercial plans: Mounjaro, Ozempic, Rybelsus, Trulicity and liraglutide (the Victoza authorized generic) ^[2]
• Individual Exchange plans, also called Individual and Family ACA Marketplace plans: Mounjaro, Ozempic, Rybelsus and Trulicity ^[2]
• Community plans: the state-specific drug lists ^[2]
• Medicare Advantage and stand-alone Part D plans: coverage is set by the member's individual plan, which providers can check through PreCheck MyScript ^[2]

UnitedHealthcare listed the GLP-1 products it says are currently available to treat diabetes as Mounjaro, Ozempic, Rybelsus, Trulicity and liraglutide (the Victoza authorized generic) ^[2]. That list is the insurer's, and it is narrower than the full set of products in the class.

FDA has a standard route for removing an approved drug when it stops being sold. The applicant tells the agency in writing that the product is no longer marketed and asks for the approval to be withdrawn under 21 CFR 314.150(c). Applicants that take that route waive their opportunity for a hearing, and the withdrawal is without prejudice to refiling ^[1]. On Aug. 4, 2025, FDA published a notice withdrawing approval of 39 new drug applications from multiple applicants, effective Sept. 3, 2025 ^[1]. The applications listed in that notice cover products including Hexadrol, Vivactil, Surmontil, Sinequan and Loxitane, among others, and the notice states that the products were no longer marketed ^[1]. A correction to that notice was published on Oct. 3, 2025 ^[1].

Why it matters for patients

Byetta and Bydureon BCise are gone, so anyone who was using either product is on something else or has stopped. The two drugs are no longer an option to start ^[2].

Which replacement a person can get depends on insurance. UnitedHealthcare publishes different preferred GLP-1 lists for its commercial, Individual Exchange, Community, and Medicare Advantage and Part D plans, and Medicare Advantage and Part D coverage is decided plan by plan ^[2]. Other insurers publish their own lists, and none of those lists appear in the records cited here.

The FDA paperwork around discontinued products is administrative. Under the process described in the agency notice, approval is withdrawn because the applicant says the drug is no longer marketed and asks for the withdrawal, not because of a safety finding ^[1]. That is a different event from a recall or a safety warning.

What happens next

The dates already on the record are the Oct. 25, 2024, Byetta discontinuation, the Oct. 28, 2024, Bydureon BCise discontinuation, and UnitedHealthcare's Dec. 19, 2024, provider notice ^[2]. On the regulatory side, FDA's withdrawal notice took effect Sept. 3, 2025, with a correction published Oct. 3, 2025 ^[1]. No further FDA action on exenatide, and no announcement about a return of either brand or a generic version, has been reported.