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Is Byetta discontinued? Exenatide (Byetta / Bydureon)

Written by The Peptide Record editorialClinical review not yet completedLast reviewed 21 October 2026Funding No vendor payment

Exenatide is a 39-amino-acid peptide GLP-1 receptor agonist, originally identified in the lizard Heloderma suspectum (the Gila monster). The FDA approved it as Byetta on 28 April 2005, and later in two extended-release forms, Bydureon and Bydureon BCise. An FDA review says the applicant notified the agency on 16 August 2024 that it planned to permanently stop marketing Byetta and Bydureon BCise. Bydureon itself was withdrawn from sale in March 2021.

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On this page

  1. Is Byetta discontinued?
  2. What Drugs@FDA shows for each exenatide product
  3. What it is, and its approval
  4. The pivotal trial evidence
  5. Safety warnings on the labels
  6. Questions people ask

In brief

Should you care? Yes if you have used Byetta or Bydureon BCise, or have read this site's semaglutide, liraglutide or tirzepatide pages. Exenatide is in the same GLP-1 receptor agonist class.

The short version

  • Byetta and Bydureon BCise: an FDA review says the applicant notified FDA on 16 August 2024 of its plan to permanently discontinue marketing both.
  • Bydureon (original): permanently withdrawn from sale as of March 2021, according to the same review.
  • Generic exenatide: FDA approved a first generic of Byetta on 19 November 2024. Drugs@FDA now lists that generic as Discontinued.
  • One record still says Prescription: a separate 2009 Byetta application, NDA 021919, still shows "Prescription" on Drugs@FDA.

Is Byetta discontinued?

An FDA pediatric pharmacovigilance review dated 14 April 2025 says: "On August 16, 2024, the applicant notified FDA of its plan to permanently discontinue marketing of Byetta." It says the same about Bydureon BCise, also on 16 August 2024.1 The same review says the applicant for the original Bydureon "discontinued marketing with permanent withdrawal from sale of all strengths of Bydureon as of March 2021."1

A generic did reach approval after that notice. FDA's list of 2024 first generic approvals includes exenatide injection USP (ANDA 206697), a generic of Byetta Injection, approved 11/19/2024 "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."2 When we checked Drugs@FDA on 21 October 2026, both strengths under ANDA 206697 were listed as Discontinued.6

What we could not confirm

The FDA sources above record the applicant's plan to discontinue marketing. They do not give a reason, and we have not found an FDA source that ties the decision to a safety problem. Drugs@FDA marketing status is a database field. If you need to know whether you can still fill a prescription, ask your pharmacist.

What Drugs@FDA shows for each exenatide product

We searched Drugs@FDA for exenatide on 21 October 2026 and found five applications:34567

ApplicationProductOriginal approvalMarketing status on Drugs@FDA
NDA 021773Byetta04/28/2005Discontinued (both strengths)3
NDA 021919Byetta (2009 application, classified "Type 6 - New Indication (no longer used)")10/30/2009Prescription (both strengths)7
NDA 022200Bydureon and Bydureon Pen01/27/2012Discontinued4
NDA 209210Bydureon BCise10/20/20171Discontinued5
ANDA 206697Exenatide (generic of Byetta)11/19/2024Discontinued (both strengths)6

The NDA 021919 entry is the only exenatide record still marked Prescription. FDA's 2025 review lists NDA 021773 as the Byetta application.17 We have not found an FDA source that explains why the 2009 record still shows that status, so we report it as listed.

What it is, and its approval

The Byetta label describes exenatide as a GLP-1 receptor agonist "that was originally identified in the lizard Heloderma suspectum," and as "a 39-amino acid peptide amide."8 Byetta is indicated "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."8 Drugs@FDA lists Byetta's original approval on 04/28/2005 as a Type 1 New Molecular Entity.3 The FDA review gives first US approval dates of 27 January 2012 for Bydureon and 20 October 2017 for Bydureon BCise.1

The pivotal trial evidence

Three 30-week, placebo-controlled trials enrolled 1,446 patients in total. Buse et al. randomized 377 patients whose type 2 diabetes was not controlled on a sulfonylurea.9 DeFronzo et al. randomized 336 patients on metformin.10 Kendall et al. randomized 733 patients on metformin plus a sulfonylurea.11 Each trial concluded that exenatide reduced HbA1c. Buse et al. reported weight loss, and the other two reported no weight gain.91011

Safety warnings on the labels

Bydureon BCise carries a boxed warning for risk of thyroid C-cell tumors. It says extended-release exenatide caused an increased incidence of thyroid C-cell tumors in rats, and that it is unknown whether it causes such tumors, including medullary thyroid carcinoma (MTC), in humans. The label says Bydureon BCise is contraindicated in patients with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).12

Byetta is contraindicated after a prior severe hypersensitivity reaction to exenatide or its excipients, and in patients with a history of drug-induced immune-mediated thrombocytopenia from exenatide products.8 Its warnings include acute pancreatitis ("Discontinue if pancreatitis is suspected"), and it says never to share a Byetta pen between patients, even if the needle is changed. Its postmarketing section lists hemorrhagic and necrotizing pancreatitis "sometimes resulting in death."8

Questions people ask

Was Byetta discontinued in 2024 in the US?

An FDA review says the applicant notified FDA on 16 August 2024 of its plan to permanently discontinue marketing Byetta.1 The main Byetta application, NDA 021773, is listed as Discontinued on Drugs@FDA.3

Is there a generic Byetta?

FDA approved a first generic of Byetta (ANDA 206697) on 19 November 2024.2 Drugs@FDA lists it as Discontinued as of 21 October 2026.6

Is Bydureon still available?

The original Bydureon was permanently withdrawn from sale as of March 2021. The applicant notified FDA in August 2024 that it planned to permanently stop marketing Bydureon BCise.1 Both are listed as Discontinued on Drugs@FDA.45

Was it discontinued for safety reasons?

The FDA sources we checked record the plan to discontinue marketing but do not give a reason.1

What you can do next

References

  1. FDA, Office of Surveillance and Epidemiology, Pediatric Postmarketing Pharmacovigilance Review: Bydureon BCise, Bydureon and Byetta (exenatide), review date April 14, 2025: fda.gov (PDF). Accessed 21 October 2026.
  2. FDA, "2024 First Generic Drug Approvals" (entry for ANDA 206697, exenatide injection USP, 11/19/2024): fda.gov. Accessed 21 October 2026.
  3. FDA, Drugs@FDA, NDA 021773 (Byetta): accessdata.fda.gov. Accessed 21 October 2026.
  4. FDA, Drugs@FDA, NDA 022200 (Bydureon): accessdata.fda.gov. Accessed 21 October 2026.
  5. FDA, Drugs@FDA, NDA 209210 (Bydureon BCise): accessdata.fda.gov. Accessed 21 October 2026.
  6. FDA, Drugs@FDA, ANDA 206697 (exenatide synthetic): accessdata.fda.gov. Accessed 21 October 2026.
  7. FDA, Drugs@FDA, NDA 021919 (Byetta): accessdata.fda.gov; also the openFDA Drugs@FDA endpoint search for exenatide (five applications), api.fda.gov. Accessed 21 October 2026.
  8. BYETTA (exenatide) injection prescribing information and Medication Guide, Revised 9/2025, via DailyMed (National Library of Medicine): dailymed.nlm.nih.gov — sections 1, 4, 5, 6.2 and 11. Accessed 21 October 2026.
  9. Buse JB et al., "Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes," Diabetes Care 2004;27(11):2628-2635, PMID 15504997 (abstract via PubMed). Accessed 21 October 2026.
  10. DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD, "Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes," Diabetes Care 2005;28(5):1092-1100, PMID 15855572 (abstract via PubMed). Accessed 21 October 2026.
  11. Kendall DM et al., "Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea," Diabetes Care 2005;28(5):1083-1091, PMID 15855571 (abstract via PubMed). Accessed 21 October 2026.
  12. BYDUREON BCISE (exenatide) extended-release injectable suspension prescribing information, Revised 05/2025: accessdata.fda.gov (PDF) — boxed warning and section 4. Accessed 21 October 2026.