Prescription medicine
Encorafenib Brand names: Braftovi
Encorafenib (Braftovi) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the encorafenib FDA label on DailyMed (effective February 26, 2026, Array BioPharma Inc.); the NDA 210496 record on Drugs@FDA; every encorafenib label on DailyMed.
Highlights of the record
FDA label of February 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBRAFTOVI is a kinase inhibitor indicated: Melanoma
in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test.
Forms and strengths
- 75 mg
Capsule.
On the market
- Earliest approval on file
- June 27, 2018 Braftovi, Array Biopharma Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- August 5, 2033 Braftovi capsules; 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
- 9,844 through July 30, 2026
What is encorafenib used for?
From the label: indications and usageBRAFTOVI is a kinase inhibitor indicated: Melanoma
in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC)
in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test. ( 1.2 , 2.1 )
in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy. […]
Conditions named in the indications of encorafenib's FDA labels, with every medicine labeled for each:
From other encorafenib labelsLung cancer: Cancer (NSCLC) BRAFTOVI is indicated, in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test [see Dosage and …
Source: FDA drug label (BRAFTOVI), Array BioPharma Inc., effective February 26, 2026 (SPL set 235dfc38-0f0b-4037-b501-7a9f4294740c), via openFDA; the full label on DailyMed
What does the patient leaflet for encorafenib 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 BRAFTOVI?BRAFTOVI can cause serious side effects, including: Risk of new skin cancers. BRAFTOVI can cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma. Talk to your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider right away about any skin changes, including a: • new wart • skin sore or reddish bump that bleeds or does not heal • change in size or color of a mole Your healthcare provider should check your skin before treatment with BRAFTOVI, every 2 months during treatment, and for up to 6 months after you stop treatment with BRAFTOVI to look for any new skin cancers. Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment with BRAFTOVI. See " What are the possible side effects of BRAFTOVI ? " for more information about side effects.
From the patient leaflet: How should I store BRAFTOVI?Store BRAFTOVI at room temperature between 68°F to 77°F (20°C to 25°C). • Store BRAFTOVI in the original bottle. • Keep the BRAFTOVI bottle tightly closed and protect it from moisture. • BRAFTOVI comes with a desiccant packet in the bottle to help protect your medicine from moisture. Do not remove the desiccant packet from the bottle. Keep BRAFTOVI and all medicines out of the reach of children.
Source: FDA drug label (BRAFTOVI), Array BioPharma Inc., effective February 26, 2026 (SPL set 235dfc38-0f0b-4037-b501-7a9f4294740c), via openFDA; the full label on DailyMed
Is there a generic for encorafenib (Braftovi)?
No generic encorafenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 13 patents for Braftovi capsules: the compound patent runs to August 27, 2030, and the last listed entry to August 5, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the encorafenib label say about other medicines?
The encorafenib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name encorafenib. 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 |
|---|---|---|
| Binimetinib | warnings and precautions | Hepatotoxicity: Monitor liver function tests before and during treatment with BRAFTOVI and binimetinib and as clinically indicated. |
| Cetuximab | warnings and precautions | Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with binimetinib or cetuximab. |
Other labels that name encorafenib
Source: FDA drug label (BRAFTOVI), Array BioPharma Inc., effective February 26, 2026 (SPL set 235dfc38-0f0b-4037-b501-7a9f4294740c), via openFDA; the full label on DailyMed
What do FAERS reports show for encorafenib?
The FDA Adverse Event Reporting System holds 9,844 reports that list encorafenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,627 are coded as a death and 2,733 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 encorafenib?
6 other medicines are given the same way (oral) and in the same FDA class as encorafenib or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Capecitabine | Colorectal cancer | 18 labelers | $0.456 per tablet 500 mg tablet | No current entry |
| Sotorasib | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
| Fruquintinib | Colorectal cancer | none listed | n/a | No current entry |
| Tipiracil and trifluridine | Colorectal cancer | none listed | n/a | No current entry |
| Adagrasib | Lung cancer, Colorectal cancer | none listed | n/a | No current entry |
| Regorafenib | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as encorafenib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to encorafenib
- 6 medicines for the same use
- Encorafenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other