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-one 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 March 20, 2027. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for SPRAVATO

International Patents:	61
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	4
Patent Applications:	288
Drug Prices:	Drug price information 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

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
Royal North Shore Hospital	Phase 4
Janssen-Cilag Pty Ltd	Phase 4
VA Office of Research and Development	Phase 4

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.

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
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
Canada	2961208
Chile	2015002736
Costa Rica	20150481
European Patent Office	3725307	RÉGIMES POSOLOGIQUES SPÉCIFIQUES AU GÉNOTYPE VAL66MET (SNP RS6265) ET PROCÉDÉS POUR LE TRAITEMENT DE LA DÉPRESSION (VAL66MET (SNP RS6265) GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR THE TREATMENT OF DEPRESSION)
European Patent Office	3934632
Mexico	2021010683
Singapore	11201507347Q

Market Dynamics and Financial Trajectory for the Drug: SPRAVATO

Introduction

SPRAVATO, a nasal spray formulation of ketamine, has been a significant player in the psychiatric pharmaceutical market since its FDA approval in 2019 for treatment-resistant depression and depressive symptoms in patients with major depressive disorder who have acute suicidal ideation or behavior. Here, we delve into the market dynamics and financial trajectory of this groundbreaking drug.

Approval and Initial Market Performance

SPRAVATO was the first FDA-approved psychedelic for commercial use, marking a new era in psychiatric treatment. Initially, its sales were modest, partly due to the COVID-19 pandemic's impact on in-clinic visits, a necessity for its administration[3].

Recent Sales Growth

In recent quarters, SPRAVATO has shown impressive sales growth. For the second quarter of 2024, global sales totaled $271 million, representing a 61% increase from the same period in the previous year and a 20% jump from the first quarter of 2024. This acceleration is attributed to increased physician and patient confidence in the drug[1].

Quarterly and Annual Sales Projections

The strong sales trajectory suggests that SPRAVATO is on pace to eclipse $1 billion in annual revenue for 2024. This is a significant milestone, especially considering that the drug was initially seen as a small product within Johnson & Johnson's vast portfolio[1].

Market Potential and Growth Expectations

Johnson & Johnson anticipates that SPRAVATO's sales could grow to between $1 billion and $5 billion annually. This forecast is supported by the drug's current performance and the expanding market for treatment-resistant depression. The global market for this condition is expected to grow due to extensive research and increased healthcare spending[1][4].

Competitive Landscape

SPRAVATO operates in a competitive market with other emerging therapies for treatment-resistant depression. Companies like Compass Pathways, which is developing psilocybin, and Atai Life Sciences, working on dimethyltryptamine, are also making strides in this field. However, SPRAVATO's head start and the backing of a major pharmaceutical company like Johnson & Johnson give it a significant advantage[1][4].

Regulatory and Developmental Activities

The regulatory environment remains crucial for SPRAVATO's success. While the FDA has approved SPRAVATO, other psychedelic therapies, such as MDMA for post-traumatic stress disorder, face regulatory hurdles. The FDA's decision on MDMA, expected by August 11, 2024, could have broader implications for the psychedelic drug market[1].

Mechanism of Action and Administration

SPRAVATO's mechanism of action involves the modulation of glutamate neurotransmission, which is different from traditional antidepressants. It is administered as a nasal spray under the supervision of a healthcare professional due to the risk of dissociation and suicidal thoughts[1][4].

Impact on the Psychedelic Drug Market

The success of SPRAVATO has significant implications for the broader psychedelic drug market. It provides evidence that psychedelics can generate meaningful sales in hard-to-treat central nervous system disorders, even if their use is restricted to hospitals or treatment clinics. This has piqued the interest of investors and large pharmaceutical companies in developing or acquiring psychedelic-based drugs[1][3].

Expert Insights

Industry experts, such as Dina Burkitbayeva, CEO of Freedom Biosciences, believe that SPRAVATO's sales indicate that psychedelics can succeed in mainstream pharma, generating hundreds of millions to billions of dollars in annual sales. This sentiment is echoed by analysts like Andrew Tsai from Jefferies, who see SPRAVATO's strong sales as a positive sign for the commercial viability of psychedelic drugs[1][3].

Future Market Forecast

The market forecast for SPRAVATO is optimistic, with the drug expected to continue its growth trajectory. A detailed analysis of forecasted sales data from 2019 to 2032 suggests that SPRAVATO will remain a key player in the treatment-resistant depression market, despite the emergence of other therapies[4].

Challenges and Opportunities

While SPRAVATO faces challenges such as regulatory scrutiny and competition from emerging therapies, it also presents opportunities for further research and development. Johnson & Johnson is developing two additional depression drugs behind SPRAVATO, seltorexant and aticaprant, which could further bolster its position in the psychiatric pharmaceutical market[1].

Conclusion

SPRAVATO's financial trajectory is marked by significant growth and promising projections. As the first FDA-approved psychedelic for commercial use, it has paved the way for other psychedelic drugs and has become a cornerstone in the treatment of treatment-resistant depression. With continued support from Johnson & Johnson and favorable market conditions, SPRAVATO is poised to remain a major player in the psychiatric pharmaceutical market.

Key Takeaways

• Strong Sales Growth: SPRAVATO's sales have accelerated, with a 61% increase in the second quarter of 2024 compared to the same period in 2023.
• Market Potential: The drug is expected to reach $1 billion to $5 billion in annual sales, driven by increasing physician and patient confidence.
• Competitive Landscape: SPRAVATO faces competition from other emerging therapies but maintains an advantage due to its early market entry and backing by Johnson & Johnson.
• Regulatory Environment: The FDA's decisions on other psychedelic therapies will impact the broader market, but SPRAVATO's approval sets a positive precedent.
• Future Forecast: The drug is expected to continue growing, with a detailed forecast suggesting significant market presence through 2032.

FAQs

Q: What is SPRAVATO used for? A: SPRAVATO is used for the treatment of treatment-resistant depression and depressive symptoms in patients with major depressive disorder who have acute suicidal ideation or behavior.

Q: How is SPRAVATO administered? A: SPRAVATO is administered as a nasal spray under the supervision of a healthcare professional due to the risk of dissociation and suicidal thoughts.

Q: What are the sales projections for SPRAVATO? A: SPRAVATO is projected to reach $1 billion to $5 billion in annual sales, with current sales already showing a strong growth trajectory.

Q: How does SPRAVATO impact the broader psychedelic drug market? A: SPRAVATO's success provides evidence that psychedelics can generate meaningful sales in hard-to-treat central nervous system disorders, attracting investor interest and large pharmaceutical companies.

Q: What are the challenges faced by SPRAVATO in the market? A: SPRAVATO faces challenges such as regulatory scrutiny, competition from emerging therapies, and the need for supervised administration due to its side effects.

Sources

1. Yahoo Finance - "In strengthening Spravato sales, a positive sign for psychedelic drugs"
2. Johnson & Johnson Investor Relations - "Johnson & Johnson Reports Q4 and Full-Year 2023 Results"
3. Microdose - "The Commercial Market for Legal Psychedelics: Spravato"
4. Research and Markets - "SPRAVATO Drug Insight and Market Forecast - 2032"
5. Johnson & Johnson Investor Relations - "Johnson & Johnson reports Q2 2024 results"