Xenleta Generic: When Will Generic Lefamulin 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
Xenleta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? March 2033 About 6.5 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 brand’s protection end? June 2036 The last of 4 listed patents Why sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistGeneric lefamulin is expected to be available in March 2033, about 6.5 years away. None is for sale yet.
Why March 2033?
It is when Xenleta’s patent 8,071,643 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to 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 Xenleta’s protection runs to June 2036, how can a generic come sooner?
The patent that runs to June 2036 (12,121,582) covers the product’s formulation. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
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 Xenleta 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.
Xenleta 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 2019 August 2019 FDA Orange Book
- Patents listed 4 last runs to June 2036 FDA Orange Book
Xenleta’s Road to a Generic
Xenleta has had the market to itself since the FDA approved it in August 2019 (Hong Kong King Friend Industrial Co Ltd). Its FDA protection (antibiotic incentive (gain)) runs to August 2029. Its 4 listed patents run to June 2036.
The first generic of Xenleta is expected in March 2033.
Why that month: patent 8,071,643, on the active ingredient and the product’s formulation, ends then. That is about 3 years before the last listed patent runs out, in June 2036.
Why a Generic Can Come Before June 2036
The last listed patent runs to June 2036, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Xenleta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xenleta’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 8,071,643, which ends in March 2033, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,153,689 | The active ingredient; the product’s formulation | March 2028 | Active |
| 9,120,727 | The active ingredient; the product’s formulation | May 2031 | Active |
| 8,071,643 Sets the expected month of generic availability | The active ingredient; the product’s formulation | March 2033 | Active |
| 12,121,582 | The product’s formulation | June 2036 | 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. | August 2024 | Ended |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | August 2029 | Active |
Source: FDA Orange Book, application 211673, 211672. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Lefamulin
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 Xenleta yet.
Approved by the FDA
Not yet. The FDA has not approved a generic lefamulin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic lefamulin 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).
Xenleta 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 Xenleta, 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.
Xenleta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 150MG BASE/15ML (EQ 10MG BASE/ML) | Solution | Intravenous | August 2019 | Prescription reference product |
| EQ 600MG BASE | Tablet | Oral | August 2019 | Prescription reference product |
Source: FDA Orange Book, Hong Kong King Friend Industrial Co Ltd. Listed for sale today by Nabriva Therapeutics US, Inc. and Meitheal Pharmaceuticals Inc. (FDA NDC Directory).
Xenleta NDC Codes and Packages
Each Xenleta 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 |
|---|---|---|---|
| 72000-0120-06 | 150 mg/15mL injection, solution | carton of 6 vials of 15 mL | Nabriva Therapeutics US, Inc. |
| 72000-0110-10 | 600 mg tablet, coated | blister pack of 10 tablets | Nabriva Therapeutics US, Inc. |
| 72000-0110-30 | 600 mg tablet, coated | bottle of 30 tablets | Nabriva Therapeutics US, Inc. |
| 71288-0039-16 | LEFAMULIN ACETATE 150 mg/15mL injection, solution | carton of 6 vials of 15 mL | Meitheal Pharmaceuticals Inc. |
| 71288-0037-10 | LEFAMULIN ACETATE 600 mg/1 tablet, coated | blister pack of 10 tablets | Meitheal Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xenleta’s own FDA approval (NDA 211673, NDA 211672) are listed, never a generic. Some codes belong to companies that repackage Xenleta: it is the same medicine in a different package.
What a Generic Xenleta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Xenleta 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 Xenleta”. 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 Xenleta
Is there a generic for Xenleta right now?
No. As of October 9, 2026 no generic lefamulin is listed for sale in the FDA NDC Directory.
When will Xenleta go generic?
March 2033 is the expected month, and that is toss-up but not certain. It is when Xenleta’s patent 8,071,643 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to June 2036, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic lefamulin be the same as Xenleta?
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 Xenleta?
Not yet. The FDA Orange Book lists no approved generic version of Xenleta.
When does the Xenleta patent expire?
The FDA Orange Book lists 4 patents for Xenleta; the last runs to June 2036. The one behind the expected month is patent 8,071,643, which ends in March 2033. 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 (March 2033) weighs all of that.
Changes to This Projection
- First generic expected March 2033 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
- RhopressaNetarsudil Mesylate2032 to 2033
- ImbruvicaIbrutinibMarch 2032
- NetspotGallium Ga-68 DotatateAugust 2032
- DaybueTrofinetide2038 to 2039
- Vantrela ERHydrocodone BitartrateTBD no date yet
- ActharCorticotropinTBD no date yet
About Xenleta
- Generic name lefamulin
- How it is taken By mouth
- Company Hong Kong King Friend Industrial Co Ltd
- More drugs Brand-name drugs starting with X
- Have a question? A pharmacist answers, free. Ask about Xenleta
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.