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

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.

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
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No			Y
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No			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
Japan	2018502168	安定な固体フィンゴリモド剤形
Taiwan	201642842	Stable solid FINGOLIMOD dosage forms
Canada	2974375	FORME GALENIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS)
Australia	2016209466

Supplementary Protection Certificates for TASCENSO ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	C300497	Netherlands		PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
0627406	SPC/GB11/026	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
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
0627406	11C0021	France		PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317

Market Dynamics and Financial Trajectory for TASCENSO ODT

Last updated: July 29, 2025

Introduction

TASCENSO ODT (Orodispersible Tablets) represents a novel pharmaceutical formulation aimed at enhancing drug delivery and patient compliance. As a product designed to dissolve rapidly in the mouth without water, TASCENSO ODT addresses a key patient need, especially in populations with swallowing difficulties. Its market potential hinges on evolving treatment paradigms, regulatory landscapes, competitive activity, and commercialization strategies. This analysis explores the current market dynamics and forecasts TASCENSO ODT’s financial trajectory within the global pharmaceutical landscape.

Market Overview

Growing Demand for Orally Dispersible Tablets

The global orally dispersible tablet market has experienced significant growth, driven by rising geriatric populations, pediatric needs, and increased prevalence of swallowing disorders. According to Mordor Intelligence, the global ODM market was valued at approximately USD 13.7 billion in 2021, with projections indicating a compound annual growth rate (CAGR) of 7-8% during 2022–2027[1]. This growth underscores a favorable environment for new products like TASCENSO ODT.

Key Therapeutic Areas

TASCENSO ODT's market penetration largely depends on its target therapeutic segments. If formulated for central nervous system (CNS) disorders, such as schizophrenia or depression, or for infectious diseases, these segments enjoy robust growth driven by unmet needs and new drug approvals. Alternatively, for chronic conditions like hypertension or diabetes, compliance improves via formulations like ODTs, supporting market expansion.

Regulatory Environment and Approvals

Regulatory agencies, notably the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), have frameworks facilitating approval of ODT formulations. The approval process emphasizes safety, efficacy, and manufacturing quality. Given the growing acceptance, regulatory pathways are streamlined, reducing time-to-market and associated costs.

Competitive Landscape

The ODT market features established players such as Actavis, Novartis, and Sun Pharmaceutical Industries, many offering formulations for similar indications. However, a proprietary formulation like TASCENSO ODT, especially with unique bioavailability or stability features, can carve a niche. Patent protection and exclusivity periods influence market share and revenue potential.

Market Penetration and Adoption Factors

Patient Preference and Compliance

Patient-centric formulations increase medication adherence, especially among pediatric, elderly, and military populations. The convenience of TASCENSO ODT positions it favorably in these segments, driving adoption and prescriptions.

Clinical Evidence and Physician Acceptance

Robust clinical data demonstrating bioequivalence or superiority over existing therapies bolster physician confidence. Integration into treatment guidelines accelerates uptake, directly influencing sales.

Distribution Channels

Key channels include hospitals, retail pharmacies, and specialty clinics. Partnerships with key healthcare providers and payers facilitate market access and reimbursement strategies, critical for revenue realization.

Revenue and Financial Trajectory Projections

Short-term (1-3 Years)

In the initial phase post-launch, revenue growth primarily depends on:

• Regulatory approval timelines
• Market access and reimbursement negotiations
• Early adoption within targeted therapeutic areas

Assuming TASCENSO ODT secures FDA approval within two years and gains swift reimbursement, modest revenues begin accruing, potentially in the hundreds of millions USD in cumulative sales globally.

Medium-term (3-5 Years)

Within 3–5 years, as manufacturing scales and physician awareness increases, sales expansion is expected. With strategic marketing, and continued clinical validation, revenues may scale to USD 500 million - 1 billion annually, assuming successful market penetration and exclusive rights.

Long-term (5+ Years)

Long-term trajectory depends on lifecycle management strategies, potential line extensions, and geographic expansion. If TASCENSO ODT becomes a first-line therapy, annual revenues could surpass USD 1 billion, aligning with blockbuster thresholds. The revenue trajectory also hinges on patent protection longevity and competitive responses.

Key Market Drivers and Challenges

Drivers

• Growing prevalence of swallowing disorders
• Patient preference for convenient dosage forms
• Enhanced compliance leading to better clinical outcomes
• Regulatory support for ODTs

Challenges

• High R&D and regulatory costs
• Potential patent expirations
• Competitive pressure from generic formulations
• Pricing and reimbursement complexities

Financial Risks and Opportunities

Risks include delays in regulatory approval, unfavorable reimbursement policies, and market saturation. Conversely, opportunities exist in expanding indications, geographic penetration (notably emerging markets), and leveraging digital health integrations for adherence monitoring.

Strategic Recommendations

To maximize TASCENSO ODT’s market and financial potential:

• Invest in robust clinical trials to demonstrate efficacy and safety
• Engage with key opinion leaders to endorse the formulation
• Develop strategic partnerships for manufacturing, distribution, and marketing
• Monitor competitive landscape continuously for innovation opportunities
• Focus on patient education to foster acceptance

Conclusion

TASCENSO ODT's market prospects are promising within the expanding ODT segment. Its success hinges on rapid regulatory approval, clinical validation, strategic marketing, and effective distribution channels. With a favorable trend towards patient-centric formulations, TASCENSO ODT possesses the potential to realize substantial revenue growth over the coming years, offering enhanced therapeutic adherence and improved health outcomes.

---

Key Takeaways

• The global ODT market is expanding at a CAGR of approximately 7-8%, bolstered by increasing demand for patient-friendly drug formulations.
• TASCENSO ODT’s success depends on swift regulatory approvals, clinical evidence, and strategic market access.
• Short-term revenues are modest but poised to grow significantly within 3–5 years, potentially reaching blockbuster status.
• Addressing competitive challenges, patent protection, and reimbursement strategies will be critical for sustained financial growth.
• Emphasizing patient-centric benefits and forming strong partnerships will optimize TASCENSO ODT’s market adoption and revenue trajectory.

---

FAQs

Q1: What therapeutic areas is TASCENSO ODT most suitable for?
A1: TASCENSO ODT is suitable for therapeutic areas requiring improved patient compliance, including CNS disorders, infectious diseases, and chronic conditions like hypertension or diabetes.

Q2: How does the regulatory landscape influence TASCENSO ODT’s market potential?
A2: Favorable regulatory frameworks for ODTs facilitate faster approval, reducing time-to-market and enabling earlier revenue generation.

Q3: What are the main factors affecting TASCENSO ODT’s adoption by physicians?
A3: Clinical evidence supporting efficacy and safety, inclusion in treatment guidelines, and demonstrated patient benefits drive physician acceptance.

Q4: How does patent protection impact the financial trajectory of TASCENSO ODT?
A4: Patents provide exclusivity, allowing premium pricing and market control for a defined period, directly influencing revenue potential.

Q5: What strategies can enhance TASCENSO ODT’s market penetration?
A5: Investing in clinical trials, engaging key opinion leaders, forming strategic partnerships, and patient education campaigns are vital strategies.

---

References

1. Mordor Intelligence. “Orally Dispersible Tablet Market – Growth, Trends, and Forecast (2022–2027).”