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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.

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
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

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
European Patent Office	3247341	FORME GALÉNIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS)
Australia	2016209466	Stable solid fingolimod dosage forms
Taiwan	201642842	Stable solid FINGOLIMOD dosage forms
China	107530301	稳定的固体芬戈莫德剂型 (STABLE SOLID FINGOLIMOD DOSAGE FORMS)

Supplementary Protection Certificates for TASCENSO ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	C 2011 005	Romania		PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1613288	2011C/030	Belgium		PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
0627406	1190015-6	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
1613288	28/2011	Austria		PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317

TASCENSO ODT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TASCENSO ODT

Introduction

TASCENSO ODT, a bioequivalent, non-generic formulation of fingolimod, has been launched in the US market to treat relapsing forms of multiple sclerosis (MS). This article delves into the market dynamics and financial trajectory of this drug, highlighting its significance, patient support services, and the broader market context.

Market Need and Patient Base

Multiple sclerosis affects an estimated 1 million people in the US, with around 200 new cases diagnosed each week. Approximately 100,000 MS patients in the US have been treated with Gilenya, the original fingolimod formulation. The introduction of TASCENSO ODT addresses a critical need for these patients, especially as Gilenya's patient support services were scheduled to be withdrawn[1][2].

Unique Formulation and Convenience

TASCENSO ODT is the first orally disintegrating tablet (ODT) approved for MS treatment in the US. Developed using Catalent's ZYDIS technology, it dissolves on the tongue in seconds without the need for water. This unique formulation offers convenience and is expected to be an attractive option for MS patients seeking ease of administration[1].

Patient Support Services

The launch of TASCENSO ODT is accompanied by Cycle Vita™, Cycle Pharmaceuticals' dedicated patient support platform. This program provides essential services such as a $0 co-pay, bridge programs, in-home baseline assessments, and first-dose observations. These services ensure that patients can continue their fingolimod treatment without interruptions and access necessary financial and medical support[1][2].

Clinical Indications and Safety Profile

TASCENSO ODT is indicated for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. It is available in 0.25 mg and 0.5 mg doses. The drug has a known safety profile, with potential side effects including bradyarrhythmia, AV blocks, and increased blood pressure. Patients with certain preexisting cardiac conditions require careful monitoring during the initial dose[1][4].

Market Growth and Projections

The global market for multiple sclerosis drugs is projected to grow significantly. In 2023, the market was estimated at $21.3 billion and is expected to reach $33.8 billion by 2030, growing at a CAGR of 6.9%. This growth is driven by advancements in MS pathology, increased prevalence of MS, and the approval of new and innovative drugs. The US market, in particular, is estimated at $5.6 billion in 2023 and is expected to continue growing[3].

Competitive Landscape

The introduction of TASCENSO ODT into the market comes at a time when generic fingolimod capsules are becoming more prevalent. However, TASCENSO ODT offers a unique advantage with its ODT formulation and comprehensive patient support services, which are not available with generic alternatives. This positions TASCENSO ODT as a competitive option for patients who need to remain on fingolimod therapy but require additional support[1][2].

Financial Implications

The financial trajectory of TASCENSO ODT is closely tied to its market acceptance and the ongoing demand for MS treatments. With a growing market and a unique value proposition, TASCENSO ODT is expected to capture a significant share of the MS drug market. The drug's pricing strategy, including the $0 co-pay program, is designed to make it more accessible to patients, which could positively impact its adoption rates and revenue growth.

Expert Insights

Industry experts highlight the importance of TASCENSO ODT in maintaining therapeutic consistency for patients stable on fingolimod therapy. Dr. Clyde E. Markowitz and Dr. Bruce A. C. Cree emphasize the benefits of TASCENSO ODT in providing continuous patient support services and ensuring that patients can avoid switching to other treatments due to unaffordable co-pay deductibles[1].

Regional Analysis

The US market is a key focus for TASCENSO ODT, given the high prevalence of MS and the existing patient base on Gilenya. The drug's launch and marketing efforts are concentrated in this region to ensure maximum impact and patient access. Other regions, such as Europe and Asia-Pacific, may also see future expansions as the global MS drug market continues to grow[3].

Regulatory and Safety Considerations

TASCENSO ODT has been approved by the FDA, and its safety profile is well-documented. However, ongoing monitoring and postmarketing surveillance are crucial to identify any rare or long-term adverse effects. The drug's contraindications and potential interactions with other medications must be carefully managed to ensure patient safety[4].

Conclusion

TASCENSO ODT represents a significant development in the treatment of multiple sclerosis, offering a convenient and bioequivalent alternative to existing fingolimod formulations. With its unique ODT formulation and comprehensive patient support services, TASCENSO ODT is well-positioned to capture a substantial share of the growing MS drug market.

Key Takeaways

• Market Need: TASCENSO ODT addresses the need for continuous patient support services as Gilenya's support programs are withdrawn.
• Unique Formulation: The ODT formulation offers convenience and ease of administration.
• Patient Support: Cycle Vita™ provides essential financial and medical support to patients.
• Market Growth: The global MS drug market is projected to grow significantly, driven by advancements and increased prevalence.
• Competitive Advantage: TASCENSO ODT's unique formulation and patient support services differentiate it from generic alternatives.
• Financial Trajectory: Expected to capture a significant market share due to its unique value proposition.

FAQs

Q: What is TASCENSO ODT used for? A: TASCENSO ODT is used for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Q: What makes TASCENSO ODT unique? A: TASCENSO ODT is the first orally disintegrating tablet (ODT) approved for MS treatment in the US, offering convenience and ease of administration.

Q: What patient support services are available for TASCENSO ODT? A: Cycle Vita™ provides patient support services including a $0 co-pay program, bridge programs, in-home baseline assessments, and first-dose observations.

Q: How does TASCENSO ODT fit into the broader MS drug market? A: TASCENSO ODT is part of a growing global MS drug market projected to reach $33.8 billion by 2030, driven by advancements and increased prevalence.

Q: What are the potential side effects of TASCENSO ODT? A: Potential side effects include bradyarrhythmia, AV blocks, and increased blood pressure, requiring careful monitoring especially for patients with preexisting cardiac conditions.

Sources

1. Catalent: New Drug, TASCENSO ODT® (Fingolimod), Launched | Catalent
2. MSCare: Cycle Pharmaceuticals to launch TASCENSO ODT® (fingolimod) in ...
3. GlobeNewswire: Multiple Sclerosis Drugs Market Outlook and Strategic Business Report 2024-2030
4. FDA: TASCENSO ODT (fingolimod) - accessdata.fda.gov