Lampit Generic: When Will Generic Nifurtimox 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
Lampit Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2027 About 10 months 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? August 2027 FDA exclusivity: orphan drug
- Can you buy a generic today? Not yet No company lists one for sale
Generic nifurtimox is expected to be available in August 2027, about 10 months away. None is for sale yet.
Why August 2027?
It is when Lampit’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease. 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 Lampit 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.
Lampit by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It 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
- under $10M a yearSmall seller
- FDA approved 2020 August 2020 FDA Orange Book
- Patents listed 0 none listed FDA Orange Book
Lampit’s Road to a Generic
Lampit has had the market to itself since the FDA approved it in August 2020 (Bayer Healthcare Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to August 2027.
The first generic of Lampit is expected in August 2027.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It 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.
Lampit Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lampit’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 |
|---|---|---|---|
| Orphan drug ODE-319 | Seven years of protection for a use in a rare disease. | August 2027 | Active |
Source: FDA Orange Book, application 213464. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Nifurtimox
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 Lampit yet.
Approved by the FDA
Not yet. The FDA has not approved a generic nifurtimox. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic nifurtimox 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).
Lampit 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 Lampit, 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.
Lampit Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 120MG | Tablet | Oral | August 2020 | Prescription reference product |
| 30MG | Tablet | Oral | August 2020 | Prescription reference product |
Source: FDA Orange Book, Bayer Healthcare Pharmaceuticals Inc. Listed for sale today by Bayer Healthcare Pharmaceuticals INC. (FDA NDC Directory).
Lampit NDC Codes and Packages
Each Lampit 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 |
|---|---|---|---|
| 50419-0751-01 | NIFURTIMOX 120 mg/1 tablet, film coated | bottle of 100 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0751-01 | NIFURTIMOX 120 mg/1 tablet, film coated | bottle of 100 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0750-01 | NIFURTIMOX 30 mg/1 tablet, film coated | bottle of 100 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0750-01 | NIFURTIMOX 30 mg/1 tablet, film coated | bottle of 100 tablets | Bayer HealthCare Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lampit’s own FDA approval (NDA 213464) are listed, never a generic. Some codes belong to companies that repackage Lampit: it is the same medicine in a different package.
What a Generic Lampit Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Lampit 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 Lampit”. 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 Lampit
Is there a generic for Lampit right now?
No. As of October 9, 2026 no generic nifurtimox is listed for sale in the FDA NDC Directory.
When will Lampit go generic?
August 2027 is the expected month, and that is probable but not certain. It is when Lampit’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease.
Will generic nifurtimox be the same as Lampit?
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 Lampit?
Not yet. The FDA Orange Book lists no approved generic version of Lampit.
When does the Lampit patent expire?
No patents are listed for Lampit in the FDA Orange Book. Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
Changes to This Projection
- First generic expected August 2027 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
- NexplanonEtonogestrel2028 to 2029
- Venlafaxine BesylateVenlafaxine BesylateMay 2028
- AemcoloRifamycinNovember 2028
- InbrijaLevodopaFebruary 2029
- RuzurgiAmifampridineJune 2032
- Definity RTPerflutrenMay 2037
About Lampit
- Generic name nifurtimox
- How it is taken By mouth
- Company Bayer Healthcare Pharmaceuticals Inc
- 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 L
- Have a question? A pharmacist answers, free. Ask about Lampit
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.