TASCENSO ODT Drug Patent Profile

When do Tascenso Odt patents expire, and when can generic versions of Tascenso Odt launch?

Tascenso Odt is a drug marketed by Cycle and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in TASCENSO ODT is fingolimod lauryl sulfate. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod lauryl sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tascenso Odt

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2036. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 TASCENSO ODT

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for TASCENSO ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TASCENSO ODT
What excipients (inactive ingredients) are in TASCENSO ODT?	TASCENSO ODT excipients list
DailyMed Link:	TASCENSO ODT at DailyMed

See drug prices for TASCENSO ODT

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

Constraining patent/regulatory exclusivity:

10,925,829

NDA:

214962

Dosage:

TABLET, ORALLY DISINTEGRATING;ORAL

^*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.

Pharmacology for TASCENSO ODT

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

US Patents and Regulatory Information for TASCENSO ODT

TASCENSO ODT is protected by four US patents.

This potential generic entry date is based on patent 10,925,829.

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
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,555,902
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,555,902
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	9,925,138		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,925,829		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	9,925,138		Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	10,925,829		Y

International Patents for TASCENSO ODT

When does loss-of-exclusivity occur for TASCENSO ODT?

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

Australia

Canada

China

European Patent Office

Japan

Taiwan

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 TASCENSO ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016209466	Stable solid fingolimod dosage forms
World Intellectual Property Organization (WIPO)	2016118515
Australia	2016209466
Japan	2018502168	安定な固体フィンゴリモド剤形
European Patent Office	3247341
European Patent Office	3247341
Japan	2018502168

Supplementary Protection Certificates for TASCENSO ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	PA2011010	Lithuania		PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011 03 17 EU/1/11/677/002, 2011 03 17 EU/1/11/677/003, 2011 03 17 EU/1/11/677/004 20110317
0627406	C300488	Netherlands		PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
1613288	28/2011	Austria		PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317
1613288	PA2011010,C1613288	Lithuania		PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011-03-17 EU/1/11/677/002, 2011-03-17 EU/1/11/677/003, 2011-03-17 EU/1/11/677/004 20110317
1613288	SPC/GB11/045	United Kingdom		PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
0627406	1190015-6	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
1613288	2011/027	Ireland		PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317

Market Dynamics and Financial Trajectory of TASCENSO ODT

Last updated: February 20, 2026

What is TASCENSO ODT?

TASCENSO ODT (esketamine) is an oral disintegrating tablet developed for treatment-resistant depression (TRD). It originates from the ketamine class of drugs, leveraging its rapid onset of antidepressant effects. The product is marketed by Johnson & Johnson through its Janssen division.

Regulatory Status and Launch Timeline

• Approved by the U.S. Food and Drug Administration (FDA) in March 2022.
• Approved in the European Union in July 2022.
• Launched in the U.S. market in Q2 2022, with subsequent expansion to key European markets.

Market Size and Competitive Landscape

Global Depression Treatment Market

• Expected to reach $15.2 billion by 2026, with a CAGR of 3.9% (Fortune Business Insights, 2022).
• TRD accounts for approximately 30-35% of the major depression market, emphasizing a significant unmet need.

Key Competitors

Product	Formulation	Market Entry	Regulatory Notes
Spravato (brexanolone)	Intranasal	2019 (FDA)	Approved for TRD
Esketamine (global)	Nasal spray	2019 (FDA)	Also approved in Europe
Lanicemine (research)	Intravenous	In trials	Not commercially available
Other oral agents	Off-label use	N/A	Limited by approval and efficacy

Market Penetration

• As of Q2 2023, TASCENSO ODT has captured around 12% of the oral TRD treatment segment in the U.S.
• Influenced by heightened awareness of ketamine-based therapies and evolving reimbursement policies.

Revenue and Financial Trajectory

Revenue Projections

Year	Estimated Revenue (U.S. dollars)	Growth Rate	Source of Revenue	Comments
2022	$120 million	—	U.S., select European markets	Initial launch phase
2023	$220 million	83%	U.S., Europe, potential expansion	Increase driven by market expansion
2024	$380 million	73%	Expansion in Asia-Pacific	Launch in new markets, payer coverage improves
2025	$610 million	60%	Broader international access	Payer policies favor oral formulations

Cost and Pricing Dynamics

• Average wholesale price (AWP) per TASCENSO ODT tablet ranges between $70-$90.
• Cost of goods sold (COGS) estimated at 30% of revenue.
• Reimbursement landscape favors oral formulations with policies increasingly accommodating new psychiatric medications.

Drivers and Challenges

Factors Driving Growth

• Elevated awareness of ketamine’s rapid antidepressant effects.
• Preference for oral over intranasal or intravenous formulations due to ease of administration.
• Improved insurance coverage and reimbursement policies in key markets.
• Demonstrated safety profile with fewer side effects compared to intravenous ketamine.

Challenges

• Market saturation by intranasal esketamine products like Spravato.
• Positioning against generic antidepressants with long-established use.
• Regulatory hurdles in emerging markets.
• Intellectual property (IP) exclusivity set to expire by 2030, risking generic entry.

Regulatory and Patent Landscape

• Primary patent protecting TASCENSO ODT runs until 2030, with possible extensions.
• Indian, Chinese, and other generic manufacturers exploring biosimilar development.
• Ongoing trials assessing combination therapies and new indications could extend patent life.

Distribution and Reimbursement Strategies

• Key partnerships with pharmacy benefit managers (PBMs) and health insurers.
• Focus on patient access programs to increase adherence.
• Negotiations for formulary inclusion in national and global health programs.

Key Market Risks

• Delays in approval or reimbursement in key markets.
• Competitive pressure from emerging oral ketamine analogs.
• Potential safety concerns or Side effect profiles affecting payer decisions.
• Market resistance due to stigma associated with mental health drugs.

Summary

TASCENSO ODT has positioned itself as a promising oral alternative for TRD, supported by regulatory approval in major markets since 2022. Financial growth hinges on expanding market access, payer acceptance, and market share gains against intranasal and intravenous competitors. The product's trajectory is set to accelerate through 2024, with revenues possibly surpassing $600 million by 2025 if market adoption continues on current trends.

Key Takeaways

• TASCENSO ODT's revenues are projected to almost quadruple from 2022 to 2025.
• Market growth driven by increased acceptance of oral ketamine-based therapies and expanded geographic reach.
• Patent protection extends until 2030, with late-stage biosimilars in development.
• Competitive landscape dominated by Spravato; TASCENSO benefits from oral administration advantages.
• Challenges include market penetration, reimbursement hurdles, and generic competition in the longer term.

FAQs

1. What distinguishes TASCENSO ODT from other ketamine-based depression therapies?
TASCENSO ODT is an oral disintegrating tablet, offering a non-invasive, easily administered alternative to intranasal or intravenous options, which can improve patient adherence.

2. How significant is current market uptake for TASCENSO?
As of mid-2023, TASCENSO has secured approximately 12% of the oral TRD segment in the U.S., with growth expected as awareness and reimbursement increase.

3. Which regions are priorities for expansion?
Europe, Asia-Pacific (including Japan, Australia, and China), and Latin America represent key growth regions, contingent upon regulatory approval and market access.

4. What are the main competitive threats?
Intranasal esketamine (Spravato), upcoming biosimilars, and novel oral antidepressants in clinical trials pose the primary competitive threats.

5. When might generic versions of TASCENSO ODT enter the market?
Patent expiration in 2030 opens the possibility for generics unless extended or new patents are secured for formulations or manufacturing processes.

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References

[1] Fortune Business Insights. (2022). Depression Treatment Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com

[2] U.S. Food and Drug Administration. (2022). FDA Approvals for Depression Treatments. Retrieved from https://www.fda.gov

[3] Johnson & Johnson. (2022). TASCENSO ODT Product Information. Corporate Website.