Prescription medicine
Sonidegib Brand names: Odomzo
Sonidegib (Odomzo) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sonidegib FDA label on DailyMed (effective December 31, 2024, Sun Pharmaceutical Industries, Inc.); the NDA 205266 record on Drugs@FDA; every sonidegib label on DailyMed.
Highlights of the record
FDA label of December 31, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY.
ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ]. Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman and is embryotoxic, fetotoxic, and teratogenic in animals. ( 5.1 , 8.1 ) Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose. […]
Used for
From the label: indications and usageODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Forms and strengths
- 200 mg
Capsule.
On the market
- Earliest approval on file
- July 24, 2015 Odomzo, Sun Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- March 30, 2036 Odomzo 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
- 1,494 through July 30, 2026
What is sonidegib used for?
From the label: indications and usageODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ODOMZO is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
FDA pharmacologic class: Hedgehog Pathway Inhibitor.
Source: FDA drug label (Odomzo), Sun Pharmaceutical Industries, Inc., effective December 31, 2024 (SPL set 028312dc-d155-4fd5-8abd-6bb9f011d3cc), via openFDA; the full label on DailyMed
What does the patient leaflet for sonidegib 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 ODOMZO?ODOMZO can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects. For females who can become pregnant: You should talk to your healthcare provider about the risks of ODOMZO to your unborn child. Your healthcare provider will do a pregnancy test before you start taking ODOMZO. In order to avoid pregnancy, you should use birth control during treatment, and for at least 20 months after your final dose of ODOMZO. Talk to your healthcare provider about what birth control method is right for you during this time. Talk to your healthcare provider right away if you have unprotected sex or if you think your birth control has failed. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant. For males: It is not known if ODOMZO is present in semen. Do not donate semen while you are taking ODOMZO and for at least 8 months after your final dose. You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with ODOMZO and for at least 8 months after your final dose to protect your female partner from being exposed to ODOMZO. Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking ODOMZO. Exposure to ODOMZO during pregnancy: If you think that you or your female partner may have been exposed to ODOMZO during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with ODOMZO, you or your healthcare provider should report your pregnancy to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984.
From the patient leaflet: What should I avoid while taking ODOMZO?Do not donate blood or blood products while you are taking ODOMZO and for 20 months after your final dose. Do not donate semen while taking ODOMZO and for at least 8 months after your final dose.
From the patient leaflet: How should I store ODOMZO?Store ODOMZO at room temperature between 68°F to 77°F (20°C to 25°C). Keep ODOMZO and all medicines out of the reach of children.
Source: FDA drug label (Odomzo), Sun Pharmaceutical Industries, Inc., effective December 31, 2024 (SPL set 028312dc-d155-4fd5-8abd-6bb9f011d3cc), via openFDA; the full label on DailyMed
Is there a generic for sonidegib (Odomzo)?
No generic sonidegib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Odomzo capsules: the compound patent runs to March 30, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sonidegib label say about other medicines?
The sonidegib label names no other medicine on this site. The labels of 1 other medicine name sonidegib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name sonidegib
Source: FDA drug label (Odomzo), Sun Pharmaceutical Industries, Inc., effective December 31, 2024 (SPL set 028312dc-d155-4fd5-8abd-6bb9f011d3cc), via openFDA; the full label on DailyMed
What do FAERS reports show for sonidegib?
The FDA Adverse Event Reporting System holds 1,494 reports that list sonidegib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 148 are coded as a death and 270 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 next?
- Other hedgehog pathway inhibitors
- the pharmacologic class, with prices and generics
- Sonidegib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other