Zevtera Generic: When Will Generic Ceftobiprole Medocaril 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
Zevtera Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2036 to 2037 A wide 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 FDA protection end? April 2034 FDA exclusivity: antibiotic incentive (gain)
- Can you buy a generic today? Not yet No company lists one for sale
Generic ceftobiprole medocaril sodium is expected to be available between 2036 and 2037. None is for sale yet.
Why 2036 to 2037?
The patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
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 Zevtera 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.
Zevtera by the Numbers
- Reason
- Awaiting FDA approvalThe patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
- 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 2024 April 2024 FDA Orange Book
- Patents listed 0 none listed FDA Orange Book
- Medicare Part D spent $25.9K in January to March 2026 CMS Part D Spending by Drug
Zevtera’s Road to a Generic
Zevtera has had the market to itself since the FDA approved it in April 2024 (Istx LLC). Its FDA protection (antibiotic incentive (gain)) runs to April 2034.
The first generic of Zevtera is expected between 2036 and 2037.
Why that month: the patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
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.
Zevtera Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zevtera’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.
| 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. | April 2029 | Active |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | April 2034 | Active |
Source: FDA Orange Book, application 218275. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Ceftobiprole Medocaril Sodium
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 Zevtera yet.
Approved by the FDA
Not yet. The FDA has not approved a generic ceftobiprole medocaril sodium. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ceftobiprole medocaril sodium 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).
Zevtera 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 Zevtera, 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.
What Medicare and Medicaid Spend on Zevtera
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 Zevtera, before manufacturer rebates.
- $25.9K
- January to March 2026, the latest CMS has posted
About $1,727 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $25,906 | – | $1,727.09 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Zevtera only, so no generic is counted in it. What CMS says it is used for: Ceftobiprole is used to treat a variety of bacterial infections. This medication is known as a cephalosporin antibiotic.
Zevtera Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 667MG/VIAL | Powder | Intravenous | April 2024 | Prescription reference product |
Source: FDA Orange Book, Istx LLC. Listed for sale today by La Jolla Pharmaceutical Company (FDA NDC Directory).
Zevtera NDC Codes and Packages
Each Zevtera 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 |
|---|---|---|---|
| 68547-0578-10 | CEFTOBIPROLE MEDOCARIL SODIUM 667 mg/1 injection, powder, for solution | box of 10 vials of 1 injection | La Jolla Pharmaceutical Company |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zevtera’s own FDA approval (NDA 218275) are listed, never a generic. Some codes belong to companies that repackage Zevtera: it is the same medicine in a different package.
What a Generic Zevtera Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Zevtera 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 Zevtera”. 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 Zevtera
Is there a generic for Zevtera right now?
No. As of October 9, 2026 no generic ceftobiprole medocaril sodium is listed for sale in the FDA NDC Directory.
When will Zevtera go generic?
2036 to 2037 is the expected window, and that is toss-up but not certain. The patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
Will generic ceftobiprole medocaril sodium be the same as Zevtera?
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 Zevtera?
Not yet. The FDA Orange Book lists no approved generic version of Zevtera.
When does the Zevtera patent expire?
No patents are listed for Zevtera in the FDA Orange Book. Why that month: the patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
Changes to This Projection
- First generic expected 2036 to 2037 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
- OnuregAzacitidine2027 to 2028
- SovaldiSofosbuvirSeptember 2029
- Vykat XRDiazoxide Choline2034 to 2035
- JideytroZidesamtinib2041 to 2042
- ArtesunateArtesunateFebruary 2044
- EmendAprepitantTBD no date yet
About Zevtera
- Generic name ceftobiprole medocaril sodium
- How it is taken Into a vein (IV)
- Company Istx LLC
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Zevtera
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, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.