FINGOLIMOD HYDROCHLORIDE - Generic Drug Details

What are the generic 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 two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fingolimod hydrochloride has ninety-eight patent family members in thirty-nine countries.

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

Summary for FINGOLIMOD HYDROCHLORIDE

International Patents:	98
US Patents:	2
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	79
Patent Applications:	1,737
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
TG Therapeutics, Inc.	PHASE2
Novartis	PHASE2
Arizona State University	PHASE2

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
Aurobindo Pharma Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207983-001	Feb 28, 2024	AB	RX	No	No
Hetero Labs Ltd V	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207933-001	May 18, 2020	AB	RX	No	No
Accord Hlthcare	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207991-001	Oct 28, 2020	AB	RX	No	No
Zydus Pharms	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207994-001	Oct 14, 2020	AB	RX	No	No
Sun Pharm	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208014-001	Dec 4, 2019		DISCN	No	No
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes	10,543,179
Hec Pharm Co Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207939-001	Nov 10, 2021	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
Morocco	34981	FORMULATIONS COMPRENANT 2-AMINO-2-2-4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL
Russian Federation	2012117563	РЕЖИМ ДОЗИРОВАНИЯ МОДУЛЯТОРА РЕЦЕПТОРА S1P
South Korea	20140014194	FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL
Australia	2010300918
Tunisia	2013000396	FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
South Africa	201306636	FORMULAIONS COMPRISING 2 -AMINO- 2-[2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
New Zealand	726133	Dosage regimen of an s1p receptor modulator

Supplementary Protection Certificates for FINGOLIMOD HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	CR 2011 00023	Denmark		PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. 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	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

Market Dynamics and Financial Trajectory for Fingolimod Hydrochloride

Last updated: November 14, 2025

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Introduction

Fingolimod Hydrochloride, marketed under the brand name Gilenya among others, has established itself as a pivotal oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). Since its FDA approval in 2010, Fingolimod has not only transformed the landscape of MS treatment but also contributed significantly to the pharmaceutical market, influencing competitiveness, pricing strategies, and R&D investments. This analysis explores the market dynamics shaping Fingolimod's trajectory and projects its financial outlook within the broader neuroimmunology therapeutics sector.

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Market Overview and Historical Context

Fingolimod is a sphingosine-1-phosphate receptor modulator that prevents lymphocyte egress from lymph nodes, reducing central nervous system infiltration of inflammatory cells in MS. The drug's approval marked the first oral DMT for MS, offering a more convenient route compared to injectable therapies like interferons and glatiramer acetate. This positioning rapidly garnered a substantial patient uptake, influencing market share dynamics.

In its initial years, Fingolimod faced competition from emerging therapies, such as teriflunomide, dimethyl fumarate, and later, monoclonal antibodies like ocrelizumab. Despite competition, Fingolimod maintained a strong presence owing to its efficacy, safety profile, and patient preference for oral administration.

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Market Dynamics Influencing Fingolimod

1. Competitive Landscape and Market Share

The MS DMT market is characterized by intense competition, with multiple drugs vying for market dominance. Fingolimod held a leading position early on, with estimates suggesting it captured approximately 60% of the oral MS DMT segment in 2012 [1]. Over time, newer oral agents and infusion therapies have eroded some of its share, compelling Pfizer (original developer) to innovate and expand indications.

The rise of second-generation S1P receptor modulators such as ponesimod and siponimod introduces nuanced differentiation based on selectivity, safety profiles, and dosing regimens. Notably, siponimod's approval for secondary progressive MS (SPMS) enhances market opportunities.

2. Regulatory Approvals and Indications Expansion

The expansion of indications substantially impacts Fingolimod’s market potential. FDA approval for SPMS in 2019 and additional labeling for pediatric populations broaden the customer base. These regulatory advances strengthen its competitive stance and support sustained revenue streams.

Furthermore, ongoing clinical trials exploring neuroprotective properties and combination therapies aim to extend Fingolimod's therapeutic relevance, potentially entering other neurodegenerative domains such as Alzheimer’s disease, expanding its market landscape beyond MS.

3. Patent Lifecycle and Generic Entry

Patent expiration is a critical market dynamic. Pfizer's exclusivity period has been challenged, with patent filings and litigations shaping market entry of generics. As of 2020, patent challenges led to the approval of generic versions in various regions, threatening to reduce pricing power [2].

The trajectory of generic entry varies regionally; while the U.S. and Europe are experiencing imminent or enacted patent cliffs, branded formulations continue controlling substantial market shares due to manufacturing complexities and regulatory delays. Price erosion attributable to generics is a key factor influencing revenue decline in mature markets.

4. Pricing Strategies and Market Penetration

Pricing strategies directly impact revenue trajectory. Despite high per-unit costs (~$70,000 annually), the oral formulation's convenience sustains demand. In regions with robust reimbursement policies, insurance coverage mitigates affordability barriers, aiding market penetration.

Conversely, in emerging markets with limited reimbursement, pricing limits access, constraining growth. Manufacturers are adopting tiered pricing and patient assistance programs to expand access.

5. Clinical Efficacy and Safety Profile

Fingolimod’s efficacy in reducing relapse rates and MRI activity has maintained its appeal. However, safety concerns—including risks of cardiac events, macular edema, infections, and bradyarrhythmias—necessitate vigilant monitoring, which can influence prescribing patterns and patient adherence.

Post-marketing surveillance and new safety data influence market dynamics. In particular, the rare but serious cardiovascular adverse events limit use in certain patient populations, thereby constraining overall market sizing.

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Financial Trajectory Analysis

1. Revenue Trends

Globally, Fingolimod’s peak revenues reached over $3 billion annually around 2016-2018 [3]. Since then, revenues have plateaued or declined due to patent expiration and market saturation, with estimates indicating a 10-15% annual decline in mature markets post-generic entry [4].

Emerging markets, however, present growth opportunities as increased MS diagnosis and healthcare infrastructure improvements expand access. The Asia-Pacific and Latin America are projected to experience compound annual growth rates (CAGR) of approximately 8–10% over the next five years, driven by infrastructural growth and disease awareness.

2. R&D Investment and Pipeline Developments

Pfizer and other pharmaceutical companies continue investing in R&D to enhance Fingolimod’s formulation, delivery systems, and explore new indications. The company's pipeline includes derivatives with improved selectivity and safety profiles, potentially extending patent life or creating new revenue streams.

Such pipeline advancements could mitigate revenue erosion from generics, although the pipeline's success remains uncertain. Strategic collaborations and licensing deals are increasingly used to expand indications and mitigate R&D risks.

3. Market Outlook and Growth Drivers

The outlook for Fingolimod remains cautiously optimistic. Key growth drivers include:

• Expanded Indications: Neuroprotective and pediatric uses can add revenue streams.
• Increased Diagnosis Rates: Growing prevalence of MS, notably in Asia, can enhance demand.
• Combination Therapies: Synergies with other agents may unlock niche markets.
• Technological Innovations: Improved formulations aimed at reducing adverse effects could gradually expand the patient base.

However, the looming patent expiration and competition from both oral and infused therapies necessitate strategic agility. The ability to innovate and adapt reimbursement strategies will be critical for sustaining profitability.

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Regulatory and Market Challenges

Regulatory bodies increasingly demand long-term safety data, influencing market access. Price pressures, especially in cost-conscious healthcare systems, could further jeopardize profit margins. Moreover, the evolving landscape of personalized medicine could pose challenges or opportunities depending on how Fingolimod's efficacy is stratified across patient subgroups.

The geopolitical landscape, exemplified by import restrictions or price controls, also influences export and distribution strategies, particularly in emerging markets.

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Conclusion

Fingolimod Hydrochloride has experienced a complex market trajectory shaped by competing therapies, patent dynamics, regulatory landscapes, and safety profiles. While it retains a significant role in MS management, particularly in developed regions, its future revenue streams will depend upon innovation, expanded indications, strategic market positioning, and management of competitive and regulatory challenges.

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Key Takeaways

• Market Maturity and Patent Expiry: Arrival of generics has diminished high-margin revenues, prompting manufacturers to innovate and pursue new indications.
• Competitive Dynamics: Newer oral agents and monoclonal antibodies continue to challenge Fingolimod’s market share, requiring differentiation through safety, efficacy, or formulation improvements.
• Regional Growth Opportunities: Emerging markets present significant upside, contingent on healthcare infrastructure development and affordability.
• Pipeline and Innovation: Ongoing clinical trials and formulation enhancements could extend the product lifecycle and maintain relevance.
• Strategic Focus: Reimbursement strategies, safety management, and indications expansion are central to sustaining financial performance.

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FAQs

1. What factors primarily influence Fingolimod’s market share decline?
The primary factors include patent expiration leading to generic competition, emergence of newer oral agents with improved safety profiles, and evolving clinical guidelines favoring personalized treatment approaches.

2. How significant are generics to Fingolimod’s future revenues?
Generics are poised to substantially impact revenues post-patent expiration, especially in regions with cost-sensitive healthcare systems. Price erosion is expected to drive down revenues unless offset by new indications or formulations.

3. Are there upcoming regulatory approvals that could enhance Fingolimod’s market prospects?
Yes, approvals for additional indications like secondary progressive MS and pediatric MS are anticipated, potentially expanding market size and duration.

4. What role does safety profile play in Fingolimod's market dynamics?
Safety concerns, including cardiovascular risks, influence prescriber confidence and patient adherence. Managing and communicating safety effectively is crucial for sustained market penetration.

5. What strategies can manufacturers adopt to sustain profitability amid patent challenges?
Strategies include developing next-generation formulations, seeking additional indications, engaging in strategic collaborations, and implementing patient assistance and tiered pricing programs for emerging markets.

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References

[1] IMS Health, "Multiple Sclerosis Market Analysis," 2012.
[2] U.S. Food and Drug Administration, "Patent Litigation and Generic Entry Data," 2020.
[3] IQVIA, "Pharmaceutical Market Reports," 2018-2020.
[4] MarketResearchFuture, "Neuroimmunology Therapeutics Market Outlook," 2022.