Utebzi Generic: When Will Generic Tebipenem Pivoxil 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
Utebzi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January to March 2038 A 3-month window Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? February 2038 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic tebipenem pivoxil hydrobromide is expected to be available between January and March 2038. None is for sale yet.
Why January to March 2038?
When a generic maker challenges a patent, FDA must wait up to 30 months before approving it. That wait ends then. We rate it probable: more likely than not, but it can still move.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Utebzi 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.
Utebzi by the Numbers
- Reason
- Court hold endsWhen a generic maker challenges a patent, FDA must wait up to 30 months before approving it. That wait ends then.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2026 June 2026 FDA Orange Book
- Patents listed 2 last runs to February 2038 FDA Orange Book
Utebzi’s Road to a Generic
Utebzi has had the market to itself since the FDA approved it in June 2026 (Glaxosmithkline LLC). Its FDA protection (antibiotic incentive (gain)) runs to June 2036. Its 2 listed patents run to February 2038.
The first generic of Utebzi is expected between January and March 2038.
Why that month: when a generic maker challenges a patent, FDA must wait up to 30 months before approving it. That wait 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.
Utebzi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Utebzi’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 |
|---|---|---|---|
| 12,226,403 | The product’s formulation; a way of using it (U-4569) | December 2037 | Active |
| 10,889,587 | The active ingredient; the product’s formulation; a way of using it (U-4570) | February 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | June 2031 | Active |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | June 2036 | Active |
Source: FDA Orange Book, application 215960. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Tebipenem Pivoxil Hydrobromide
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 company is recorded as having applied to the FDA to make a generic Utebzi yet.
Approved by the FDA
Not yet. The FDA has not approved a generic tebipenem pivoxil hydrobromide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic tebipenem pivoxil hydrobromide for sale with the FDA.
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).
Utebzi 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 Utebzi, 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.
Utebzi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 300MG BASE | Tablet | Oral | June 2026 | Prescription reference product |
Source: FDA Orange Book, Glaxosmithkline LLC. Listed for sale today by GlaxoSmithKline LLC (FDA NDC Directory).
Utebzi NDC Codes and Packages
Each Utebzi 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 |
|---|---|---|---|
| 00173-0956-76 | TEBIPENEM PIVOXIL HYDROBROMIDE 300 mg/1 tablet, film coated | carton of 10 blister packs of 8 tablets | GlaxoSmithKline LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Utebzi’s own FDA approval (NDA 215960) are listed, never a generic. Some codes belong to companies that repackage Utebzi: it is the same medicine in a different package.
What a Generic Utebzi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Utebzi 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 Utebzi”. 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 Utebzi
Is there a generic for Utebzi right now?
No. As of October 9, 2026 no generic tebipenem pivoxil hydrobromide is listed for sale in the FDA NDC Directory.
When will Utebzi go generic?
January to March 2038 is the expected window, and that is probable but not certain. When a generic maker challenges a patent, FDA must wait up to 30 months before approving it. That wait ends then.
Will generic tebipenem pivoxil hydrobromide be the same as Utebzi?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Utebzi?
Not yet. The FDA Orange Book lists no approved generic version of Utebzi.
When does the Utebzi patent expire?
The FDA Orange Book lists 2 patents for Utebzi; the last runs to February 2038. 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 window on this page (January to March 2038) weighs all of that.
Changes to This Projection
- First generic expected January to March 2038 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
- XareltoRivaroxabanMarch 2027
- Esmolol HydrochlorideEsmolol HydrochlorideMarch 2033
- BarhemsysAmisulprideFebruary 2038
- KomziftiZiftomenibNovember 2039
- SymbravoMeloxicam and RizatriptanMay 2040
- OsmoprepSodium Phosphate, Dibasic, Anhydrous and Sodium Phosphate, Monobasic, MonohydrateTBD no date yet
About Utebzi
- Generic name tebipenem pivoxil hydrobromide
- How it is taken By mouth
- Company Glaxosmithkline LLC
- More drugs Brand-name drugs starting with U
- Have a question? A pharmacist answers, free. Ask about Utebzi
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.