Nuzolvence Generic: When Will Generic Zoliflodacin 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
Nuzolvence Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2039 About 12.5 years away 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? December 2035 FDA exclusivity: antibiotic incentive (gain)
- Can you buy a generic today? Not yet No company lists one for sale
Generic zoliflodacin is expected to be available in January 2039, about 12.5 years away. None is for sale yet.
Why January 2039?
It is when Nuzolvence’s patents 8,889,671 and 9,187,495 end. They cover the active ingredient and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. 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 Nuzolvence 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.
Nuzolvence by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- 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 2025 December 2025 FDA Orange Book
- Patents listed 6 last runs to January 2034 FDA Orange Book
Nuzolvence’s Road to a Generic
Nuzolvence has had the market to itself since the FDA approved it in December 2025 (Entasis Therapeutics Inc). Its FDA protection (antibiotic incentive (gain)) runs to December 2035. Its 6 listed patents run to January 2034.
The first generic of Nuzolvence is expected in January 2039.
Why that month: patents 8,889,671 and 9,187,495, on the active ingredient and a way of using it, end 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.
Nuzolvence Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Nuzolvence’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: patents 8,889,671 and 9,187,495, which end in January 2034; the first generic is expected after it, in January 2039, about 12.5 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,040,528 | A way of using it (U-4369) | October 2029 | Active |
| 8,658,641 | The active ingredient | June 2030 | Active |
| 8,889,671 Sets the expected month of generic availability | The active ingredient; a way of using it (U-4369) | January 2034 | Active |
| 9,187,495 Sets the expected month of generic availability | The active ingredient; a way of using it (U-4369) | January 2034 | Active |
| 9,540,394 | A way of using it (U-4369) | January 2034 | Active |
| 9,839,641 | A way of using it (U-4369) | January 2034 | 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. | December 2030 | Active |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | December 2035 | Active |
Source: FDA Orange Book, application 219491. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Zoliflodacin
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 Nuzolvence yet.
Approved by the FDA
Not yet. The FDA has not approved a generic zoliflodacin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic zoliflodacin 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).
Nuzolvence 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 Nuzolvence, 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.
Nuzolvence Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 3GM/PACKET | For suspension | Oral | December 2025 | Prescription reference product |
Source: FDA Orange Book, Entasis Therapeutics Inc. Listed for sale today by La Jolla Pharmaceutical Company (FDA NDC Directory).
Nuzolvence NDC Codes and Packages
Each Nuzolvence 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 |
|---|---|---|---|
| 68547-0915-10 | ZOLIFLODACIN 3 g/1 for suspension | packet of 1 for suspension | La Jolla Pharmaceutical Company |
Source: the FDA NDC Directory, current listings only. Only packages sold under Nuzolvence’s own FDA approval (NDA 219491) are listed, never a generic. Some codes belong to companies that repackage Nuzolvence: it is the same medicine in a different package.
What a Generic Nuzolvence Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Nuzolvence 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 Nuzolvence”. 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 Nuzolvence
Is there a generic for Nuzolvence right now?
No. As of October 9, 2026 no generic zoliflodacin is listed for sale in the FDA NDC Directory.
When will Nuzolvence go generic?
January 2039 is the expected month, and that is probable but not certain. It is when Nuzolvence’s patents 8,889,671 and 9,187,495 end. They cover the active ingredient and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic zoliflodacin be the same as Nuzolvence?
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 Nuzolvence?
Not yet. The FDA Orange Book lists no approved generic version of Nuzolvence.
When does the Nuzolvence patent expire?
The FDA Orange Book lists 6 patents for Nuzolvence; the last runs to January 2034. The one behind the expected month is patents 8,889,671 and 9,187,495, which end in January 2034. 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 2039) weighs all of that.
Changes to This Projection
- First generic expected January 2039 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
- TradjentaLinagliptinJuly to December 2026
- ZecuitySumatriptan SuccinateOctober 2032
- PrevymisLetermovirFebruary 2033
- BylvayOdevixibat2036 to 2037
- Lonhala MagnairGlycopyrrolateDecember 2036
- FrindovyxCyclophosphamideTBD no date yet
About Nuzolvence
- Generic name zoliflodacin
- How it is taken By mouth
- Company Entasis Therapeutics Inc
- More drugs Brand-name drugs starting with N
- Have a question? A pharmacist answers, free. Ask about Nuzolvence
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.