Bydureon BCise Generic: When Will Generic Exenatide Synthetic Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Bydureon BCise Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2031 About 4.5 years away Why then?
- Has the FDA approved a generic? November 2024 1 company approved Why not on sale?
- When does the last patent end? April 2031 7 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic exenatide synthetic is expected to be available in April 2031, about 4.5 years away. None is for sale yet.
Why April 2031?
It is when Bydureon BCise’s patent 8,895,033 ends. That patent covers the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since November 2024, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually. The FDA has already approved one company to make a generic, and how many of them launch decides how far the price falls. See the price pattern
What should I do now?
Keep taking Bydureon BCise as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Bydureon BCise by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2017 October 2017 FDA Orange Book
- Patents listed 7 last runs to April 2031 FDA Orange Book
- Generics FDA-approved 1 company, approved November 2024 FDA Orange Book
- Pharmacies pay $234.22 per mL, up 0.1% in a year NADAC, February 2026
- Medicare Part D spent $37.8M in 2025, for 14.9K people CMS Part D Spending by Drug
- Medicaid prescriptions 14.9K in the last four reported quarters, $12.2M CMS Medicaid drug utilization, to Q4 2025
Bydureon BCise’s Road to a Generic
Bydureon BCise has had the market to itself since the FDA approved it in October 2017 (Astrazeneca AB). Its 7 listed patents run to April 2031 (1 already expired).
The first generic of Bydureon BCise is expected in April 2031.
Why that month: patent 8,895,033, on the product’s formulation and a way of using it, ends then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Bydureon BCise Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Bydureon BCise’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 8,895,033, which ends in April 2031, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 6,515,117 | The active ingredient; the product’s formulation; a way of using it (U-2588) | April 2026 with the pediatric extension | Expired |
| 8,329,648 | A way of using it (U-2590, U-2593, U-2594, U-2596, U-2595, U-2588, U-2589, U-3189, U-3188, U-3190) | February 2027 with the pediatric extension | Active |
| 8,906,851 | A way of using it (U-2590, U-2593, U-2597, U-2589, U-3188, U-3189, U-2588, U-3190) | February 2027 with the pediatric extension | Active |
| 9,884,092 | A way of using it (U-2593, U-2589, U-2594, U-2596, U-2597, U-2595, U-2590, U-2588, U-3188, U-3190, U-3189) | February 2027 with the pediatric extension | Active |
| 8,501,698 | A way of using it (U-2588) | December 2027 with the pediatric extension | Active |
| 8,361,972 | A way of using it (U-2588) | September 2028 with the pediatric extension | Active |
| 8,895,033 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-2597, U-2590, U-2601, U-2589, U-2602, U-3190, U-3188, U-3189) | April 2031 with the pediatric extension | Active |
Source: FDA Orange Book, application 209210. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Exenatide Synthetic
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for Bydureon BCise, but the FDA has already approved 1 company (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in November 2024. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic exenatide synthetic for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Amneal Eu Ltd | November 2024 | 300MCG/1.2ML (250MCG/ML), 600MCG/2.4ML (250MCG/ML) | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Bydureon BCise Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Bydureon bcise 2 mg autoinject
$234.22 per mL in February 2026, up 0.1% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| February 2026 | $234.22 |
| January 2026 | $234.22 |
| February 2024 | $234.05 |
| January 2024 | $234.05 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Bydureon BCise today: $234.22 per mL for Bydureon bcise 2 mg autoinject in February 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Dollar figures apply FDA’s median drops to the $234.22 pharmacies pay per mL today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Bydureon BCise
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Bydureon BCise, before manufacturer rebates.
- $37.8M
- 2025, the whole year
For 14,934 people, about $1,114 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $37,843,513 | 14,934 | $1,114.32 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Bydureon BCise only, so no generic is counted in it. What CMS says it is used for: Exenatide is used either alone or with other medications, and with a proper diet and exercise program, to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.
Medicaid Prescriptions by Quarter
14,884 prescriptions in the four quarters to Q4 2025, $12.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 0 | $0 |
| Q3 2025 | 29 | $22,412 |
| Q2 2025 | 2,288 | $1,873,454 |
| Q1 2025 | 12,567 | $10,267,716 |
Source: CMS Medicaid State Drug Utilization Data, over Bydureon BCise’s own package codes.
Bydureon BCise Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 2MG/0.85ML (2MG/0.85ML) | Suspension, extended release | Subcutaneous | October 2017 | Discontinued reference product |
Source: FDA Orange Book, Astrazeneca AB. Listed for sale today by AstraZeneca Pharmaceuticals LP (FDA NDC Directory).
Bydureon BCise NDC Codes and Packages
Each Bydureon BCise package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00310-6540-04 | 2 mg/.85mL injection, suspension, extended release | carton of 4 cartridges of .85 mL | AstraZeneca Pharmaceuticals LP |
| 00310-6540-85 | 2 mg/.85mL injection, suspension, extended release | cartridge of .85 mL | AstraZeneca Pharmaceuticals LP |
Source: the FDA NDC Directory, current listings only. Only packages sold under Bydureon BCise’s own FDA approval (NDA 209210) are listed, never a generic. Some codes belong to companies that repackage Bydureon BCise: it is the same medicine in a different package.
What a Generic Bydureon BCise Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Bydureon BCise as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Bydureon BCise”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Bydureon BCise
Is there a generic for Bydureon BCise right now?
No. As of October 9, 2026 no generic exenatide synthetic is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Bydureon BCise go generic?
April 2031 is the expected month, and that is toss-up but not certain. It is when Bydureon BCise’s patent 8,895,033 ends. That patent covers the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic exenatide synthetic be the same as Bydureon BCise?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved one company to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Bydureon BCise?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in November 2024: Amneal Eu Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Bydureon BCise patent expire?
The FDA Orange Book lists 7 patents for Bydureon BCise; the last runs to April 2031, counting a six-month pediatric extension. The one behind the expected month is patent 8,895,033, which ends in April 2031. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (April 2031) weighs all of that.
How much does Bydureon BCise cost now?
Pharmacies paid about $234.22 per mL for Bydureon bcise 2 mg autoinject in February 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected April 2031 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
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- Signifor LARPasireotide PamoateMay 2028
- DuobriiHalobetasol Propionate and Tazarotene2034 to 2035
- IwilfinEflornithine HydrochlorideFebruary 2036
- VivjoaOteseconazoleApril 2036
- OhtuvayreEnsifentrineJune 2038
About Bydureon BCise
- Generic name exenatide synthetic
- How it is taken Injection under the skin
- Company Astrazeneca AB
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Bydureon BCise
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.