Prescription medicine

Esketamine Brand names: Spravato

Esketamine (Spravato) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $429.98 per unit (Spravato 84 mg dose pack) in the October 7, 2026 NADAC survey.

No generic listed
Boxed warning
DEA Schedule III

Check it at the source: the esketamine FDA label on DailyMed (effective March 31, 2026, Janssen Pharmaceuticals, Inc.); the NDA 211243 record on Drugs@FDA; every esketamine label on DailyMed.

Highlights of the record

FDA label of March 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

SEDATION; DISSOCIATION; RESPIRATORY DEPRESSION; ABUSE AND MISUSE.

and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: SEDATION; DISSOCIATION; RESPIRATORY DEPRESSION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Risk for sedation, dissociation, and respiratory depression after administration. Monitor patients for at least two hours after administration. ( 5.1 , 5.2 , 5.3 ) Potential for abuse and misuse. Consider the risks and benefits of prescribing SPRAVATO prior to using in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse. ( 5.4 ) SPRAVATO is only available through a restricted program called the SPRAVATO REMS. ( 5.5 ) Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. SPRAVATO is not approved for use in pediatric patients. ( 5.6 ) Sedation Patients are at risk for sedation after administration of SPRAVATO [see Warnings and Precautions (5.1) ]. Dissociation Patients are at risk for dissociative or perceptual changes after administration of SPRAVATO [see Warnings and Precautions (5.2) ]. […]

Used for

From the label: indications and usage
SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant SPRAVATO is a non-competitive N -methyl D -aspartate (NMDA) receptor antagonist indicated for the treatment of: Treat

Forms and strengths

28 mg/.2ml

Solution.

On the market

Earliest approval on file: March 5, 2019 Spravato, Janssen Pharms; 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: February 18, 2040 Spravato spray; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $429.98 per unit Spravato 84 mg dose pack
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is esketamine used for?

From the label: indications and usage
SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant SPRAVATO is a non-competitive N -methyl D -aspartate (NMDA) receptor antagonist indicated for the treatment of: Treatment-resistant depression (TRD) in adults, as monotherapy or in conjunction with an oral antidepressant. ( 1 ) Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. […]

Source: FDA drug label (Spravato), Janssen Pharmaceuticals, Inc., effective March 31, 2026 (SPL set d81a6a79-a74a-44b7-822c-0dfa3036eaed), via openFDA; the full label on DailyMed

What does the patient leaflet for esketamine 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 SPRAVATO?
SPRAVATO can cause serious side effects, including: Sedation, dissociation, and respiratory depression. SPRAVATO may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), and breathing problems (respiratory depression and respiratory arrest). Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out. Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO. Your healthcare provider will decide when you are ready to leave the healthcare setting. Abuse and misuse. There is a risk for abuse and misuse with SPRAVATO, which may lead to physical and psychological dependence. Your healthcare provider should check you for signs of abuse, misuse, and dependence before and during treatment. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence in drug addiction. SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression, abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO can only be administered at healthcare settings certified in the SPRAVATO REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program. Increased risk of suicidal thoughts and actions. […]

From the patient leaflet: What should I avoid while taking SPRAVATO?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO. Do not take part in these activities until the next day following a restful sleep. See " What is the most important information I should know about SPRAVATO? " What are the possible side effects of SPRAVATO? SPRAVATO may cause serious side effects, including: See " What is the most important information I should know about SPRAVATO? " Increased blood pressure. SPRAVATO can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO and for at least 2 hours after you take SPRAVATO. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO. […]

Source: FDA drug label (Spravato), Janssen Pharmaceuticals, Inc., effective March 31, 2026 (SPL set d81a6a79-a74a-44b7-822c-0dfa3036eaed), via openFDA; the full label on DailyMed

Is there a generic for esketamine (Spravato)?

No generic esketamine is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 7 patents for Spravato spray, the last expiring on February 18, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2019 earliest approval on file
2040 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for esketamine (Spravato)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $429.98 per unit (Spravato 84 mg dose pack), up 8% from $399.10 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Spravato 56 mg dose pack (brand)

$426.30

$373.28

July 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Spravato 56 mg dose pack	Brand	$426.30 per unit	n/a	+8%
Spravato 84 mg dose pack	Brand	$429.98 per unit	n/a	+8%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the esketamine label say about other medicines?

The esketamine label names 4 other medicines in its interaction, contraindication or warning sections. 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
Armodafinil	drug interactions	Concomitant use with psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil) may increase blood pressure [see Warnings and Precautions (5.7) ].
Ketamine	contraindications	… Precautions (5.7) ] History of intracerebral hemorrhage [see Warnings and Precautions (5.7) ] Hypersensitivity to esketamine, ketamine, or any of the excipients.
Methylphenidate	drug interactions	Concomitant use with psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil) may increase blood pressure [see Warnings and Precautions (5.7) ].
Modafinil	drug interactions	Concomitant use with psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil) may increase blood pressure [see Warnings and Precautions (5.7) ].

Check esketamine against other medicines

Source: FDA drug label (Spravato), Janssen Pharmaceuticals, Inc., effective March 31, 2026 (SPL set d81a6a79-a74a-44b7-822c-0dfa3036eaed), via openFDA; the full label on DailyMed

What next?

Check an interaction: what two or more labels say about each other