FINGOLIMOD HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for fingolimod hydrochloride and what is the scope of patent protection?

Fingolimod hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Ltd, Bionpharma, Chartwell Rx, Dr Reddys, Ezra Ventures, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in nineteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fingolimod hydrochloride has two hundred and forty-six patent family members in fifty countries.

There are twenty drug master file entries for fingolimod hydrochloride. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for FINGOLIMOD HYDROCHLORIDE

International Patents:	246
US Patents:	4
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	75
Patent Applications:	747
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINGOLIMOD HYDROCHLORIDE
What excipients (inactive ingredients) are in FINGOLIMOD HYDROCHLORIDE?	FINGOLIMOD HYDROCHLORIDE excipients list
DailyMed Link:	FINGOLIMOD HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FINGOLIMOD HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tang-Du Hospital	Phase 1/Phase 2
The Methodist Hospital Research Institute	Phase 2
General Hospital of Shenyang Military Region	Phase 4

See all FINGOLIMOD HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for FINGOLIMOD HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.5MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FINGOLIMOD HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for FINGOLIMOD HYDROCHLORIDE

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for FINGOLIMOD HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GILENYA	Capsules	fingolimod hydrochloride	0.25 mg	022527	1	2018-07-19
GILENYA	Capsules	fingolimod hydrochloride	0.5 mg	022527	19	2014-09-22

US Patents and Regulatory Information for FINGOLIMOD HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208014-001	Dec 4, 2019	AB	RX	No	No
Prinston Inc	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208003-001	Sep 7, 2022	AB	RX	No	No
Aurobindo Pharma Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207983-001	Feb 28, 2024	AB	RX	No	No
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes	8,324,283*PED				Y
Mylan	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208005-001	Jan 19, 2021	AB	RX	No	No
Zydus Pharms	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207994-001	Oct 14, 2020	AB	RX	No	No
Biocon Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207979-001	Dec 4, 2019	AB	RX	No	No

Expired US Patents for FINGOLIMOD HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018	5,604,229*PED
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	6,004,565
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	5,604,229*PED

International Patents for FINGOLIMOD HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	2008016133	MODULADORES DEL RECEPTOR S1P PARA EL TRATAMIENTO DE ESCLEROSIS MULTIPLE. (S1P RECEPTOR MODULATORS FOR TREATING MULTIPLE SCLEROSIS.)
Australia	2016266058	S1P receptor modulators for treating multiple sclerosis
European Patent Office	2482810	SCHÉMA POSOLOGIQUE D'UN MODULATEUR DES RÉCEPTEURS DE S1P (DOSAGE REGIMEN OF AN S1P RECEPTOR MODULATOR)
New Zealand	586280	Oral pharmaceutical composition comprising FTY720 and mannitol
Peru	20170913	FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
France	2854073	COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN AGONISTE DU RECEPTEUR S1P ET UN ALCOOL DE SUCRE
Cyprus	1117071

Supplementary Protection Certificates for FINGOLIMOD HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	C01613288/01	Switzerland		PRODUCT NAME: FINGOLOMOD; REGISTRATION NO/DATE: SWISSMEDIC 60916 20110103
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	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	107 5008-2011	Slovakia		FIRST REGISTRATION NO/DATE: EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004, 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
0627406	2011020	Ireland		PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011

FINGOLIMOD HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fingolimod Hydrochloride

Introduction to Fingolimod Hydrochloride

Fingolimod hydrochloride, marketed under names such as Gilenya, Fynefta, and Filosir, is a sphingosine-1-phosphate (S1P) receptor modulator used primarily for the treatment of relapsing forms of multiple sclerosis (MS). This oral medication has revolutionized the management of MS by reducing the frequency of relapses and delaying the progression of disability.

Market Size and Growth

The global fingolimod hydrochloride market is experiencing steady growth. As of 2023, the market was valued at US$ 26 million and is projected to reach US$ 37 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.9% during the forecast period of 2024-2030[1].

Key Drivers of Market Growth

Several factors are driving the growth of the fingolimod hydrochloride market:

Advancements in Immunology and Drug Delivery Systems

Advancements in immunology and drug delivery systems have enhanced the efficacy of fingolimod hydrochloride formulations. These improvements have made the treatment more effective and tolerable for patients, contributing to increased adoption[4].

Government Initiatives and Support

Government initiatives and support for the treatment of chronic neurological disorders have fostered innovation and increased access to fingolimod hydrochloride. In emerging markets, government programs have driven growth by making the drug more accessible[5].

Strategic Alliances and Partnerships

Strategic alliances among pharmaceutical companies have boosted research and marketing efforts, further driving the market growth. These collaborations have led to better distribution, marketing, and development of fingolimod hydrochloride capsules[4].

Increasing Awareness and Diagnosis of MS

The increasing incidence of MS worldwide, coupled with growing awareness and diagnosis of the condition, has significantly contributed to the demand for fingolimod hydrochloride. Early treatment initiatives are also fueling market growth[4].

Market Restraints and Challenges

Despite the growth, the market faces several challenges:

Quality Control and Production Issues

Quality control and production issues have slowed the expansion of the fingolimod hydrochloride capsule market. Ensuring consistent quality and addressing manufacturing hurdles are critical for sustained growth[4].

Barriers to Entry and Operational Hurdles

New entrants in the market face significant barriers, including operational hurdles and the need to comply with stringent regulatory requirements. These challenges can limit market penetration and expansion[4].

Dominance of Established Treatments

The dominance of established injectable MS treatments hinders the market penetration of fingolimod hydrochloride capsules. Overcoming this competition and convincing healthcare providers and patients of the benefits of oral treatments is a significant challenge[4].

Market Opportunities

Several opportunities exist for the growth and diversification of the fingolimod hydrochloride market:

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in emerging markets, are enhancing the distribution and availability of fingolimod capsules. This expansion is expected to increase market reach and accessibility[4].

Diversification in Dosage Formulations

The potential for diversification in dosage formulations caters to various patient needs, offering a competitive edge. Developing different formulations can help in addressing side effects and improving patient compliance[4].

Increasing Awareness of Early MS Treatment

Increasing awareness about the importance of early MS treatment is fueling market growth. Educational campaigns and healthcare provider initiatives are crucial in this regard[4].

Competitive Landscape

The competitive landscape of the fingolimod hydrochloride market is dynamic, with several key players:

• Dr. Reddy's Laboratories
• Senova Technology
• Metrochem
• Toronto Research Chemicals
• BOC Sciences
• Arcadia
• Amadis Chemical
• LKT Laboratories
• Selleck Chemicals
• Hefei Home Sunshine Pharmaceutical
• Clinivex
• Tecoland
• Novartis AG (the original developer and marketer of Gilenya)[1][4].

Financial Trajectory

The financial trajectory of the fingolimod hydrochloride market is positive, driven by the factors mentioned above. Here are some key financial metrics:

• Market Size in 2023: US$ 26 million
• Projected Market Size in 2030: US$ 37 million
• CAGR: 4.9% during the forecast period 2024-2030[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of fingolimod hydrochloride. Regulatory approvals and compliance are essential for market entry and expansion. For instance, fingolimod was approved by the FDA and European Medicines Agency (EMA) in 2009, and it has been registered in various countries including Australia, where it is used to treat relapsing forms of MS[2].

Nonclinical and Clinical Findings

Nonclinical and clinical studies have supported the efficacy and safety of fingolimod hydrochloride. These studies have shown that fingolimod can significantly reduce the frequency of relapses and delay the progression of disability in MS patients. The drug's mechanism of action involves modulating S1P receptors, which helps in sequestering lymphocytes away from the central nervous system[2].

Conclusion

The market for fingolimod hydrochloride is poised for steady growth, driven by advancements in immunology, government initiatives, and strategic alliances among pharmaceutical companies. Despite challenges such as quality control issues and competition from established treatments, the market offers several opportunities for expansion and diversification.

Key Takeaways

• The global fingolimod hydrochloride market is expected to grow at a CAGR of 4.9% from 2024 to 2030.
• The market is driven by advancements in immunology, government initiatives, and strategic alliances.
• Key challenges include quality control issues, barriers to entry, and competition from established treatments.
• Opportunities for growth include advancements in healthcare infrastructure, diversification in dosage formulations, and increasing awareness of early MS treatment.
• The competitive landscape is dynamic with several key players, including Dr. Reddy's Laboratories, Senova Technology, and Novartis AG.

FAQs

What is the primary use of fingolimod hydrochloride?

Fingolimod hydrochloride is primarily used for the treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS and secondary progressive MS with superimposed relapses[2].

What is the projected market size of fingolimod hydrochloride by 2030?

The global fingolimod hydrochloride market is projected to reach US$ 37 million by 2030[1].

What are the key drivers of the fingolimod hydrochloride market?

Key drivers include advancements in immunology, government initiatives, strategic alliances among pharmaceutical companies, and increasing awareness and diagnosis of MS[4].

Who are the main players in the fingolimod hydrochloride market?

Main players include Dr. Reddy's Laboratories, Senova Technology, Metrochem, Toronto Research Chemicals, BOC Sciences, Arcadia, Amadis Chemical, LKT Laboratories, Selleck Chemicals, Hefei Home Sunshine Pharmaceutical, Clinivex, Tecoland, and Novartis AG[1].

What are the challenges faced by the fingolimod hydrochloride market?

Challenges include quality control and production issues, barriers to entry, competition from established injectable MS treatments, and intellectual property challenges such as potential patent expirations and generic competition[4].

Sources:

1. Global Fingolimod Hydrochloride Market Research Report 2024 - Valuates Reports
2. Australian Public Assessment Report for Fingolimod - TGA
3. Outlook for Global Medicines through 2021 - IQVIA
4. Fingolimod Hydrochloride Capsules Market Size 2025-2030 - 360 Research Reports
5. When will the GILENYA patents expire, and when will generic versions be available? - Drug Patent Watch