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SPRAVATO

NDA

ESKETAMINE HYDROCHLORIDE | N211243 | JANSSEN PHARMACEUTICALS INC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Mar. 5, 2033

Mar. 20, 2027

Sep. 10, 2035

Sep. 10, 2035

Sep. 10, 2035

Mar. 14, 2034

Feb. 18, 2040

I-959

Jan. 17, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Janssen Pharmaceuticals, Inc. et al v. Hikma Pharmaceuticals USA Inc. et al 1:2023cv00595	D. Del.	2023-05-31	Terminated 2023-08-16	—
JANSSEN PHARMACEUTICALS, INC. et al v. ALKEM LABORATORIES LTD. et al 1:2023cv02939 4 patentsANDA 218468esketamine	D.N.J.	2023-05-30	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

20 trials from ClinicalTrials.gov — 1 recruiting, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery NCT03756961	N/A	Recruiting	Göteborg University	220	2019-05-01 → 2029-12-31
Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants NCT02568176	Phase 1	Completed	Janssen Research & Development, LLC	71	2015-10 → 2016-02
A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide NCT02133001	Phase 2	Completed	Janssen Research & Development, LLC	68	2014-05-23 → 2016-02-01
A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression NCT02417064	Phase 3	Completed	Janssen Research & Development, LLC	346	2015-08-10 → 2018-02-20
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression NCT02493868	Phase 3	Completed	Janssen Research & Development, LLC	719	2015-10-01 → 2018-02-16
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine NCT00847418	Phase 1	Completed	University Hospital, Basel, Switzerland	—	2009-02 → 2009-10
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression NCT02422186	Phase 3	Completed	Janssen Research & Development, LLC	139	2015-08-20 → 2017-08-10
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression NCT03434041	Phase 3	Completed	Janssen Research & Development, LLC	252	2018-05-25 → 2021-04-13
A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression NCT02418585	Phase 3	Completed	Janssen Research & Development, LLC	236	2015-08-07 → 2017-11-06
Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)NCT01394757	N/A	Completed	Medical University of Vienna	52	2011-08 → 2012-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$429.43

per ea

Lowest NADAC/Unit

$426.30

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50458002803SPRAVATO 84 MG DOSE PACK	$429.43	EA	Brand	—	2026-06-17
50458002802SPRAVATO 56 MG DOSE PACK	$426.30	EA	Brand	—	2026-01-29

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$520.99

Highest Price

$1193.50

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50458-0028-02SPRAVATO 28MG SOLN,NASAL DEVICE	$795.66	FSS	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0028-02SPRAVATO 28MG SOLN,NASAL DEVICE	$520.99	Big4	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0028-03SPRAVATO 28MG SOLN,NASAL DEVICE	$1193.50	FSS	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0028-03SPRAVATO 28MG SOLN,NASAL DEVICE	$776.56	Big4	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Spravato (2024)

Total Spending

$128.1M

Total Claims

84,544

Beneficiaries

5,542

Avg Cost/Unit

$394.89

Spending Trend

$7.6M(2019)→$21.8M(2020)→$32.9M(2021)→$50.0M(2022)→$80.5M(2023)→$128.1M(2024)

YoY Change:+3.3%

5yr CAGR:+5.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

SUPRIYA LIFESCIENCE LTDESKETAMINE HYDROCHLORIDE

DMF 364262021

AREVIPHARMA GMBHESKETAMINE HYDROCHLORIDE

DMF 369902022

MAITHRI DRUGS PRIVATE LTDESKETAMINE HYDROCHLORIDE

DMF 370122022

ALKEM LABORATORIES LTDESKETAMINE HYDROCHLORIDE

DMF 374612022

NORTEC QUIMICA SAESKETAMINE HYDROCHLORIDE

DMF 376472022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Jun 26, 2026	SUPPL -29	View Letter (PDF)
Apr 21, 2026	SUPPL -28	View Letter (PDF)
Jan 26, 2026	SUPPL -27	View Letter (PDF)
Oct 10, 2025	SUPPL -25	View Letter (PDF)
Aug 1, 2025	SUPPL -24	View Letter (PDF)
May 19, 2025	SUPPL -21	View Letter (PDF)
May 1, 2025	SUPPL -19	View Letter (PDF)
Mar 28, 2025	SUPPL -18	View Letter (PDF)
Feb 4, 2025	SUPPL -16	View Letter (PDF)
Jan 2, 2025	SUPPL -13	View Letter (PDF)
Nov 5, 2024	SUPPL -15	View Letter (PDF)
Oct 19, 2023	SUPPL -12	View Letter (PDF)
Jan 5, 2022	SUPPL -6	View Letter (PDF)
Aug 3, 2020	SUPPL -4	View Letter (PDF)
Feb 12, 2020	SUPPL -3	View Letter (PDF)
Jun 26, 2019	SUPPL -2	View Letter (PDF)
May 13, 2019	SUPPL -1	View Letter (PDF)
Mar 6, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 28MG BASE

RLD

7 patents1 exclusivity▴

SPRAY;NASAL | Approved: Mar 5, 2019

Patents (7) · 25 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8785500	Mar 5, 2033	—	—	—	—
9592207	Mar 20, 2027	—	—	—	—
10869844	Sep 10, 2035	—	—	—	—
11173134	Sep 10, 2035	—	—	—	—
11311500	Sep 10, 2035	—	—	—	—
11446260	Mar 14, 2034	—	—	—	—
11883526	Feb 18, 2040	—	—	—	—

Exclusivities (1)

Code	Date	Status
I-959	Jan 17, 2028	Active