Prescription medicine
Neratinib Brand names: Nerlynx
Neratinib (Nerlynx) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the neratinib FDA label on DailyMed (effective July 2, 2026, Puma Biotechnology, Inc.); the NDA 208051 record on Drugs@FDA; every neratinib label on DailyMed.
Highlights of the record
FDA label of July 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
Forms and strengths
- 40 mg
Tablet.
On the market
- Earliest approval on file
- July 17, 2017 Nerlynx, Puma Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 18, 2031 Nerlynx tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,294 through July 30, 2026
What is neratinib used for?
From the label: indications and usageNERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. ( 1.1 ) In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. […]
Conditions named in the indications of neratinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Nerlynx), Puma Biotechnology, Inc., effective July 2, 2026 (SPL set d1e41dcf-e82a-47c2-a0ad-6c6eef621834), via openFDA; the full label on DailyMed
What does the patient leaflet for neratinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about NERLYNX?NERLYNX may cause serious side effects, including: Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. Diarrhea may lead to loss of too much body salts and fluid, which can cause dehydration. Your healthcare provider will prescribe NERLYNX in one of two ways to help manage diarrhea: Full dose of NERLYNX: Your healthcare provider will prescribe the antidiarrheal medicine loperamide for you during your first 2 months (56 days) of treatment with NERLYNX and then as needed. Your healthcare provider will tell you exactly how much and how often to take this medicine. If you are prescribed the full dose of NERLYNX from the start of your treatment, be sure that your healthcare provider also prescribes antidiarrheals with NERLYNX. You should start taking loperamide with your first dose of NERLYNX. After 2 months (56 days) of treatment with NERLYNX, follow your healthcare provider's instructions about taking loperamide as needed to control diarrhea. A lower starting dose of NERLYNX: Your healthcare provider will start you on a lower dose of NERLYNX for the first 2 weeks of treatment and then increase you to a full dose NERLYNX regimen. Tell your healthcare provider right away if you develop diarrhea. You may be prescribed loperamide as needed. To help prevent or reduce diarrhea during treatment with NERLYNX: Your healthcare provider may also need to give you additional antidiarrheals, fluids, and electrolytes to manage diarrhea when you start treatment with NERLYNX. Follow your healthcare provider's instructions on how to take antidiarrheal medicines. Always take antidiarrheals exactly as your healthcare provider tells you. […]
From the patient leaflet: What should I avoid while taking NERLYNX?You should avoid eating products that contain grapefruit during treatment with NERLYNX.
From the patient leaflet: How should I store NERLYNX?Store NERLYNX at room temperature between 68°F to 77°F (20°C to 25°C). Keep NERLYNX and all medicines out of the reach of children.
Source: FDA drug label (Nerlynx), Puma Biotechnology, Inc., effective July 2, 2026 (SPL set d1e41dcf-e82a-47c2-a0ad-6c6eef621834), via openFDA; the full label on DailyMed
Is there a generic for neratinib (Nerlynx)?
No generic neratinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 9 patents for Nerlynx tablets: the compound patent runs to December 29, 2030, and the last listed entry to July 18, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the neratinib label say about other medicines?
The neratinib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name neratinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Capecitabine | warnings and precautions | Diarrhea was reported in 83% of NERLYNX plus capecitabine treated patients in NALA, a randomized placebo-controlled trial in the metastatic breast cancer setting who were required to receive anti-diarrheal prophylaxis in the first 21-day cycle. |
| Loperamide | warnings and precautions | Diarrhea was reported in 83% of NERLYNX plus capecitabine treated patients in NALA, a randomized placebo-controlled trial in the metastatic breast cancer setting who were required to receive anti-diarrheal prophylaxis in the first 21-day cycle. |
Other labels that name neratinib
Source: FDA drug label (Nerlynx), Puma Biotechnology, Inc., effective July 2, 2026 (SPL set d1e41dcf-e82a-47c2-a0ad-6c6eef621834), via openFDA; the full label on DailyMed
What do FAERS reports show for neratinib?
The FDA Adverse Event Reporting System holds 2,294 reports that list neratinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 360 are coded as a death and 678 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as neratinib?
17 other medicines are given the same way (oral) and in the same FDA class as neratinib or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Abemaciclib | Breast cancer | none listed | n/a | No current entry |
| Lapatinib ditosylate | Breast cancer | 3 labelers | n/a | No current entry |
| Ribociclib | Breast cancer | none listed | $289.72 per unit 600 mg daily dose | No current entry |
| Tucatinib | Breast cancer | none listed | n/a | No current entry |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to neratinib
- 17 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Neratinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other