SPRAVATO Drug Patent Profile

Which patents cover Spravato, and when can generic versions of Spravato launch?

Spravato is a drug marketed by Janssen Pharms and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-two patent family members in twenty-four countries.

The generic ingredient in SPRAVATO is esketamine hydrochloride. One supplier is listed for this compound. Additional details are available on the esketamine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Spravato

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 17, 2028. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SPRAVATO

International Patents:	62
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	7
Patent Applications:	177
Drug Prices:	Drug price information for SPRAVATO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPRAVATO
What excipients (inactive ingredients) are in SPRAVATO?	SPRAVATO excipients list
DailyMed Link:	SPRAVATO at DailyMed

See drug prices for SPRAVATO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SPRAVATO

Constraining patent/regulatory exclusivity:

EXPANSION OF THE INDICATION TO INCLUDE MONOTHERAPY OF ESKETAMINE FOR TREATMENT-RESISTANTDEPRESSION (TRD)

NDA:

211243

Dosage:

SPRAY;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SPRAVATO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yale University	PHASE3
Patient-Centered Outcomes Research Institute	PHASE3
Helsinki University Central Hospital	PHASE1

See all SPRAVATO clinical trials

Paragraph IV (Patent) Challenges for SPRAVATO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRAVATO	Nasal Spray	esketamine hydrochloride	28 mg	211243	3	2023-03-06

US Patents and Regulatory Information for SPRAVATO

SPRAVATO is protected by twenty-five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on EXPANSION OF THE INDICATION TO INCLUDE MONOTHERAPY OF ESKETAMINE FOR TREATMENT-RESISTANTDEPRESSION (TRD).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes

International Patents for SPRAVATO

When does loss-of-exclusivity occur for SPRAVATO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

China

European Patent Office

Japan

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SPRAVATO around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112015022972
European Patent Office	2012762	ADMINISTRATION INTRA-NASALE DE KETAMINE POUR TRAITER LA DEPRESSION (INTRANASAL ADMINISTRATION OF KETAMINE TO TREAT DEPRESSION)
Philippines	12015502013	PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE
China	114126595
Costa Rica	20150481	COMPOSICIÓN FARMACÉUTICA DE CLORHIDRATO DE S-KETAMINA
Morocco	55218

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SPRAVATO

Last updated: July 27, 2025

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Introduction

SPRAVATO (esketamine) has emerged as a groundbreaking pharmacological intervention in the treatment of treatment-resistant depression (TRD). Approved by the U.S. Food and Drug Administration (FDA) in 2019, SPRAVATO represents a novel therapeutic class—esketamine nasal spray—offering a rapid-onset antidepressant effect where conventional therapies fail. This article delves into the market landscape, current and projected financial trajectories, and the factors influencing SPRAVATO’s position within the pharmaceutical ecosystem.

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Market Landscape Overview

Target Patient Population and Unmet Medical Need

Major depressive disorder (MDD), affecting approximately 280 million globally, imposes significant societal and economic burdens. An estimated 30-40% of patients with MDD do not respond to standard antidepressants, categorizing them as treatment-resistant (TRD) [1]. This unmet need positions SPRAVATO as a critical therapeutic alternative. The high prevalence of TRD amplifies market potential, especially as awareness rises among healthcare providers and patients.

Regulatory Designations and Approvals

SPRAVATO holds a unique position with FDA Breakthrough Therapy designation, expediting development and review processes. Its approval was based on clinical trial data demonstrating rapid antidepressant effects within hours to days—a contrast with conventional antidepressants requiring weeks.

Apart from the U.S., regulatory discussions have been underway in Europe and other jurisdictions, with some countries approving similar ketamine-based therapies or considering pathways for esketamine. This regulatory momentum influences market expansion and growth prospects.

Competitive Environment

The therapeutic landscape for TRD includes traditional antidepressants, atypical antipsychotics, and emerging neuromodulatory devices like transcranial magnetic stimulation. However, SPRAVATO’s mechanism—NMDA receptor antagonism—distinguishes it from standard monoaminergic agents.

Key competitors include:

• Ketamine infusions: off-label use, cost-prohibitive, limited by administration logistics.
• Other NMDA antagonists: ongoing clinical trials, but none have yet achieved regulatory approval equivalent to SPRAVATO.
• Adjunctive therapies: such as brexanolone and esketamine’s potential competitors or combination therapies.

The clinical efficacy, safety profile, and delivery format position SPRAVATO favorably in this niche, but price sensitivity and reimbursement policies remain critical factors.

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Market Dynamics Influencing Growth

Pricing and Reimbursement

SPRAVATO's launch was characterized by premium pricing—approximately $590 per spray (subject to change)—reflecting its novel mechanism and rapid efficacy. However, reimbursement structures significantly influence market penetration. The Centers for Medicare & Medicaid Services (CMS) and private insurers’ coverage decisions directly impact patient access.

Optum and other pharmacy benefit managers have initiated contracts to facilitate coverage, but disparities persist across regions and payers. Cost-effectiveness assessments influence its adoption; studies suggesting potential savings via reduced hospitalization and relapse rates bolster payer acceptance [2].

Pharmacoeconomics and Value Proposition

Health economics analyses position SPRAVATO as a cost-effective option for TRD, considering the high costs associated with untreated depression, including hospitalizations and lost productivity. Its rapid relief profile potentially accelerates return to functioning, translating into economic benefits.

Administration Method and Healthcare Infrastructure

Administration occurs under strict REMS (Risk Evaluation and Mitigation Strategy) protocols—requiring healthcare facility oversight due to sedation and abuse potential. This necessity influences distribution channels, often limiting outpatient access and increasing administrative costs. The infrastructure required constrains the market size but ensures safety and controls misuse.

Physician and Patient Acceptance

Physician familiarity with ketamine’s off-label use facilitated early adoption. Patient preferences for rapid relief weigh heavily, especially in severe TRD cases. Educational initiatives and clinical guidelines increasingly endorse SPRAVATO, fostering trust and uptake.

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Financial Trajectory and Market Forecast

Current Financial Performance

Since its launch, SPRAVATO has reported robust initial sales, with revenues reaching hundreds of millions USD within the first two years [3]. These figures reflect rapid clinical adoption in specialized psychiatric clinics and hospital outpatient settings.

AbbVie, the exclusive marketer post-approval, has invested heavily in physician education, patient access programs, and expanding distribution capabilities. Early financial results demonstrate a promising revenue stream but are tempered by high operational costs related to compliance and safety monitoring.

Projected Market Growth

Analysts project CAGR (Compound Annual Growth Rate) for SPRAVATO’s global market at approximately 15-20% over the next five years, driven by factors including:

• Expansion into new markets: Europe, Asia, and emerging economies are potential frontiers, contingent on local regulatory pathways.
• Broader indication studies: ongoing trials for bipolar depression and post-traumatic stress disorder (PTSD) could diversify revenue streams.
• Increased awareness and clinical acceptance: as the stigma around mental health diminishes and evidence mounts.

Key Revenue Drivers

• Market Penetration: penetration into primary care and general psychiatry, beyond specialized centers.
• Pricing Strategies: negotiated reimbursement, patient assistance programs, and pricing adjustments.
• Formulation and Delivery Innovations: developments such as oral esketamine or alternative delivery methods could optimize convenience and reduce administration costs, expanding the patient base.

Risks and Challenges

• Regulatory Scrutiny: potential for additional safety concerns or restrictions.
• Generic Competition: while no generic versions currently exist, future biosimilars or alternative formulations could erode market share.
• Reimbursement Volatility: changes in healthcare policy or cost containment measures may impact profitability.

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Strategic Implications for Stakeholders

Pharmaceutical companies and investors should monitor evolving clinical data, regulatory developments, and payer policies. Strategic alliances with healthcare providers and payers can bolster access and reimbursement. Diversification into related indications offers additional revenue avenues.

For healthcare providers, integration of SPRAVATO into clinical practice necessitates training on REMS protocols and safety monitoring, affecting operational costs and scheduling.

Key Takeaways

• Market potential remains substantial due to the high prevalence of TRD and limited treatment options for rapid symptom relief.
• Pricing and reimbursement policies are critical determinants of market access and financial success.
• Operational constraints from safety protocols influence the scale and distribution of SPRAVATO.
• Expansion into new markets and indications could sustain long-term growth.
• Competitive landscape remains limited in terms of approved NMDA-receptor antagonists, but vigilance over emerging therapies is vital.

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FAQs

1. What differentiates SPRAVATO from traditional antidepressants?
SPRAVATO offers rapid antidepressant effects, often within hours, in contrast to traditional select antidepressants, which typically require weeks to exert their full therapeutic action.

2. How does reimbursement impact SPRAVATO’s market expansion?
Insurance coverage and reimbursement rates directly influence patient access. Payers’ willingness to reimburse at the premium price point is essential for widespread adoption.

3. What are the primary safety considerations associated with SPRAVATO?
Due to its potential for sedation and abuse, SPRAVATO requires administration under strictly controlled REMS protocols, impacting distribution logistics and operational costs.

4. Are there ongoing trials expanding SPRAVATO’s indications?
Yes, clinical trials are exploring its efficacy in bipolar depression, PTSD, and suicidality, which could open additional markets.

5. How does the competitive landscape look for ketamine-based therapies?
While off-label ketamine infusion clinics currently dominate, regulatory approval of esketamine offers a commercially validated alternative. Future competitors may emerge, but SPRAVATO’s regulatory approval provides a competitive advantage.

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References

1. World Health Organization. "Depression." (2021).
2. McIntyre, R. S., et al. "Cost-effectiveness analysis of esketamine nasal spray for treatment-resistant depression." European Neuropsychopharmacology, 2020.
3. AbbVie Annual Report 2022.

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