Bydureon 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 Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2030 About 3.5 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? September 2028 6 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 January 2030, about 3.5 years away. None is for sale yet.
Why January 2030?
A patent that protects the brand runs out. After that, approved generics can be sold. 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 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 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 2012 January 2012 FDA Orange Book
- Patents listed 6 last runs to September 2028 FDA Orange Book
- Generics FDA-approved 1 company, approved November 2024 FDA Orange Book
Bydureon’s Road to a Generic
Bydureon has had the market to itself since the FDA approved it in January 2012 (Astrazeneca AB). Its 6 listed patents run to September 2028 (1 already expired).
The first generic of Bydureon is expected in January 2030.
Why that month: a patent that protects the brand runs out. After that, approved generics can be sold.
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 Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Bydureon’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.
| 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-2596, U-2595, U-2589, U-2588, U-2590, U-2593, U-2594, U-3189, U-3190, U-3188) | February 2027 with the pediatric extension | Active |
| 8,906,851 | A way of using it (U-2588, U-2589, U-2593, U-2590, U-3189, U-3190, U-3188) | February 2027 with the pediatric extension | Active |
| 9,884,092 | A way of using it (U-2593, U-2594, U-2595, U-2596, U-2590, U-2588, U-2589, U-3189, U-3190, U-3188) | February 2027 with the pediatric extension | Active |
| 8,501,698 | The product’s formulation; 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 |
Source: FDA Orange Book, application 022200. 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, 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 Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Bydureon, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay 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).
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.
Bydureon Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 2MG/VIAL | For suspension, extended release | Subcutaneous | January 2012 | Discontinued reference product |
Source: FDA Orange Book, Astrazeneca AB. Listed for sale today by AstraZeneca Pharmaceuticals LP (FDA NDC Directory).
Bydureon NDC Codes and Packages
Each Bydureon 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 |
|---|---|---|---|
| 00310-6530-04 | 2 mg/.65mL injection, suspension, extended release | tray of 4 cartridges of .65 mL | AstraZeneca Pharmaceuticals LP |
Source: the FDA NDC Directory, current listings only. Only packages sold under Bydureon’s own FDA approval (NDA 22200) are listed, never a generic. Some codes belong to companies that repackage Bydureon: it is the same medicine in a different package.
What a Generic Bydureon Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Bydureon 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”. 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
Is there a generic for Bydureon 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 go generic?
January 2030 is the expected month, and that is toss-up but not certain. A patent that protects the brand runs out. After that, approved generics can be sold.
Will generic exenatide synthetic be the same as Bydureon?
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?
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 patent expire?
The FDA Orange Book lists 6 patents for Bydureon; the last runs to September 2028, counting a six-month pediatric extension. 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 (January 2030) weighs all of that.
Changes to This Projection
- First generic expected January 2030 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
- SigniforPasireotide DiaspartateDecember 2026
- VivitrolNaltrexoneJanuary 2027
- AmvuttraVutrisiran SodiumJuly 2036
- OgsiveoNirogacestat2037 to 2038
- ItovebiInavolisibOctober 2038
- DuaveeBazedoxifene Acetate and Estrogens, ConjugatedTBD no date yet
About Bydureon
- 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
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.