FINGOLIMOD LAURYL SULFATE - Generic Drug Details

What are the generic sources for fingolimod lauryl sulfate and what is the scope of freedom to operate?

Fingolimod lauryl sulfate is the generic ingredient in one branded drug marketed by Cycle and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fingolimod lauryl sulfate has seven patent family members in seven countries.

One supplier is listed for this compound.

Summary for FINGOLIMOD LAURYL SULFATE

International Patents:	7
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in FINGOLIMOD LAURYL SULFATE?	FINGOLIMOD LAURYL SULFATE excipients list
DailyMed Link:	FINGOLIMOD LAURYL SULFATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FINGOLIMOD LAURYL SULFATE

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 FINGOLIMOD LAURYL SULFATE

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

Anatomical Therapeutic Chemical (ATC) Classes for FINGOLIMOD LAURYL SULFATE

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AE	Sphingosine-1-phosphate (S1P) receptor modulators
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FINGOLIMOD LAURYL SULFATE

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

International Patents for FINGOLIMOD LAURYL SULFATE

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 FINGOLIMOD LAURYL SULFATE

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

FINGOLIMOD LAURYL SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fingolimod Lauryl Sulfate

Introduction

Fingolimod lauryl sulfate, marketed as Tascenso, is a significant advancement in the treatment of relapsing forms of multiple sclerosis (MS). This drug, a sphingosine 1-phosphate receptor modulator, has been approved via the 505(b)(2) regulatory pathway, leveraging the established safety and efficacy profile of its predecessor, Gilenya (fingolimod).

FDA Approval and Regulatory Pathway

Tascenso was approved using the 505(b)(2) pathway, which allows for the submission of an application that relies on the findings of safety and effectiveness for a previously approved drug, in this case, Gilenya. The approval was granted for the 0.25 mg dose, specifically for pediatric patients 10 years and older weighing up to 40 kg, after demonstrating bioequivalence in pivotal studies[1].

Market Indications

Fingolimod lauryl sulfate is indicated for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This broad indication aligns with the approved uses of Gilenya, positioning Tascenso as a viable alternative, particularly for pediatric patients[1][3].

Pharmacokinetics and Bioequivalence

The bioequivalence of Tascenso to Gilenya was established through two pivotal studies, FGL-P01 and FGL-P02. These studies showed that the pharmacokinetic parameters of Tascenso met the standard bioequivalence criteria, ensuring that the drug delivers comparable efficacy and safety to Gilenya[1].

Clinical Trials and Efficacy

The efficacy of fingolimod, the active ingredient in Tascenso, has been extensively demonstrated in clinical trials such as the FREEDOMS, FREEDOMS II, and TRANSFORMS trials. These trials highlighted fingolimod's ability to reduce relapse rates, slow disease progression, and decrease MRI lesions and brain atrophy in patients with RRMS[3].

Patient Populations

Tascenso is particularly beneficial for pediatric patients with MS, a population that often faces challenges with traditional treatments. The drug's oral disintegrating tablet form makes it easier to administer, especially in younger patients. Additionally, the drug's safety profile in various patient populations, including those with hepatic and renal impairments, has been well-documented[3].

Market Competition

The market for MS treatments is highly competitive, with several disease-modifying therapies available. However, Tascenso's unique formulation and approval for pediatric use provide a distinct market niche. The drug competes with other oral and injectable MS treatments but offers the advantage of an orally disintegrating tablet, which can improve patient compliance[4].

Financial Trajectory

Approval and Launch

The approval of Tascenso marked a significant milestone for its manufacturer, Handa Pharma. The drug's launch was anticipated to expand the market share for fingolimod-based treatments, particularly in the pediatric segment. The financial impact of this approval includes potential revenue growth from the new indication and patient population[1].

Revenue Projections

Given the established efficacy and safety of fingolimod, Tascenso is expected to generate substantial revenue. The drug's approval for pediatric use opens up a new market segment, which could contribute significantly to the overall revenue of the drug. Market analysts project that the MS treatment market will continue to grow, driven by the increasing prevalence of the disease and the demand for effective treatments.

Cost and Pricing

The pricing strategy for Tascenso will be crucial in determining its market success. The drug's cost-effectiveness compared to other MS treatments will influence its adoption by healthcare providers and payers. Given its bioequivalence to Gilenya, Tascenso is likely to be priced competitively, ensuring it remains a viable option for patients and healthcare systems[2].

Challenges and Opportunities

Patent Exclusivities

The approval of Tascenso was initially delayed due to patent exclusivities related to Gilenya. However, with these exclusivities having expired, Tascenso can now be fully marketed, presenting a significant opportunity for revenue growth[1].

Regulatory Guidance

The FDA's draft guidance on fingolimod lauryl sulfate provides a clear roadmap for future approvals and studies, ensuring that any new formulations or indications will meet regulatory standards. This guidance helps in maintaining the drug's market position and facilitates further development[2].

Global Market Expansion

Tascenso's approval in the U.S. sets the stage for potential global market expansion. The drug's efficacy and safety profile make it a strong candidate for approval in other regions, further expanding its revenue potential[4].

Key Takeaways

• Approval and Indications: Tascenso (fingolimod lauryl sulfate) is approved for the treatment of relapsing forms of MS in pediatric patients 10 years and older weighing up to 40 kg.
• Bioequivalence: Demonstrated bioequivalence to Gilenya, ensuring comparable efficacy and safety.
• Market Niche: Unique formulation and approval for pediatric use provide a distinct market advantage.
• Financial Trajectory: Expected to generate significant revenue from the new indication and patient population.
• Challenges and Opportunities: Managed patent exclusivities and regulatory guidance support market growth and future development.

FAQs

Q: What is the primary indication for Tascenso (fingolimod lauryl sulfate)?

A: Tascenso is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in pediatric patients 10 years and older weighing up to 40 kg.

Q: How does Tascenso differ from Gilenya?

A: Tascenso is an orally disintegrating tablet form of fingolimod, while Gilenya is available in a traditional oral tablet form. Tascenso is specifically approved for pediatric patients, whereas Gilenya is approved for a broader age range.

Q: What are the key clinical trials that established the efficacy of fingolimod?

A: The FREEDOMS, FREEDOMS II, and TRANSFORMS trials demonstrated the efficacy of fingolimod in reducing relapse rates and slowing disease progression in patients with RRMS.

Q: How does the FDA's draft guidance impact the market for Tascenso?

A: The FDA's draft guidance provides a clear regulatory pathway for future studies and approvals, ensuring that Tascenso meets regulatory standards and facilitating further market expansion.

Q: What are the potential financial implications of Tascenso's approval?

A: The approval of Tascenso is expected to generate significant revenue from the new indication and patient population, contributing to the overall growth of the MS treatment market.

Sources

1. FDA Summary Review: "Summary Review - Tascenso (fingolimod lauryl sulfate orally disintegrating tablet)"[1].
2. FDA Draft Guidance: "Draft Guidance on Fingolimod Lauryl Sulfate"[2].
3. StatPearls: "Fingolimod - StatPearls - NCBI Bookshelf"[3].
4. Patsnap: "Fingolimod Lauryl Sulfate - Drug Targets, Indications, Patents"[4].