GILENYA Drug Patent Profile

Which patents cover Gilenya, and what generic alternatives are available?

Gilenya is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has ninety-eight patent family members in thirty-nine countries.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gilenya

A generic version of GILENYA was approved as fingolimod hydrochloride by BIOCON LTD on December 4^th, 2019.

Summary for GILENYA

International Patents:	98
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	33
Patent Applications:	987
Drug Prices:	Drug price information for GILENYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GILENYA
What excipients (inactive ingredients) are in GILENYA?	GILENYA excipients list
DailyMed Link:	GILENYA at DailyMed

See drug prices for GILENYA

Recent Clinical Trials for GILENYA

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

Sponsor	Phase
Medical University of South Carolina	PHASE2
The Methodist Hospital Research Institute	Phase 2
Genuine Research Center, Egypt	Phase 1

See all GILENYA clinical trials

Pharmacology for GILENYA

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

Paragraph IV (Patent) Challenges for GILENYA

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 GILENYA

GILENYA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018		RX	Yes	No					Y
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes

Expired US Patents for GILENYA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010

International Patents for GILENYA

When does loss-of-exclusivity occur for GILENYA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 GILENYA around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20131352	COMPOSICION FARMACEUTICA QUE CONTIENE UN AGONISTA DEL RECEPTOR S1P Y UN ALCOHOL DE AZUCAR
Japan	2016155840
Russian Federation	2012148593	ПРЕДНАЗНАЧЕННАЯ ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Chile	2013002810	Composicion farmaceutica solida oral que comprende a) un compuesto 2-amino-2-[2-(4-octil-fenil)-etil]-propano-1,3-diol (fingolimod) en una cantidad de 0,5 mg o menos, o una sal del mismo, b) un relleno y c) un estabilizante que comprende una ciclodextrina; y su uso para tratar una enfermedad autoinmune tal como esclerosis multiple.
Japan	2013505983

Supplementary Protection Certificates for GILENYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1613288	CR 2011 00023	Denmark		PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
1613288	399	Finland
1613288	C01613288/01	Switzerland		PRODUCT NAME: FINGOLOMOD; REGISTRATION NO/DATE: SWISSMEDIC 60916 20110103
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

Market Dynamics and Financial Trajectory for GILENYA (Fingolimod): An In-Depth Analysis

Last updated: December 10, 2025

Executive Summary

GILENYA (fingolimod) is a pioneering oral disease-modifying therapy (DMT) approved for relapsing forms of multiple sclerosis (RRMS) by the U.S. FDA in 2010. As one of the first sphingosine-1-phosphate (S1P) receptor modulators, GILENYA set a benchmark for oral MS therapies. This report dissects its market landscape, competitive positioning, regulatory environment, financial performance, and future prospects. It offers vital insights for stakeholders considering investments, market entry, or competitive strategies within the neuroimmunology segment.

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What Are the Market Fundamentals Underpinning GILENYA?

1. Disease Prevalence and Unmet Needs

Multiple sclerosis (MS) affects approximately 2.8 million people globally, with an annual incidence of 3 per 100,000 in developed nations. The increasing prevalence—at a CAGR of 2-3% over the past decade—drives demand for efficacious, convenient treatments.

2. GILENYA’s Mechanism and Therapeutic Positioning

Fingolimod functions as an S1P receptor modulator, effectively sequestering lymphocytes and preventing their infiltration into the CNS, thus reducing MS relapse rates. Its oral administration offers superior compliance over injectable therapies, spearheading its market appeal.

3. Market Size and Revenue Estimates

Global MS drug sales, valued at approximately $22 billion (2022), are projected to grow at ~6% CAGR over the next five years, with oral therapies like GILENYA contributing increasingly due to patient preference for non-injectable options.

Year	MS Drug Market ($B)	GILENYA Revenue ($M)	Share of MS Market (%)
2020	20.7	950	4.6
2022	22.0	1,200	5.5
2025	28.0 (projected)	1,800 (projected)	6.4 (projected)

4. Key Drivers of Growth

• Patient Preference for Oral Agents: Shift from injectables to oral drugs enhances GILENYA’s viability.
• Expanding Global Access: Increasing approval in emerging markets.
• Innovative Pipeline: Next-generation S1P modulators (e.g., ozanimod, ponesimod) introduce competition but also validate the mechanism.

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How Are Competition and Regulatory Factors Shaping GILENYA’s Market?

1. Competitive Landscape

Competitor	Key Drugs	Market Share (2022)	Differentiators
Novartis	Gilyena (ozanimod)	~3%	Better safety profile, CNS selectivity
Sanofi/Genzyme	Aubagio (teriflunomide)	~10%	Different MOA, oral
Biogen	Tecfidera (dimethyl fumarate)	~5%	Oral, immune-modulating
AbbVie	Skyrizi, Humira (non-MS)	N/A	Diversified portfolio

Gilenya faces strategic pressure from newer agents with improved safety profiles and dosing regimens.

2. Regulatory Approvals and Labeling

• FDA (2010): Approval for RRMS.
• EMA (2011): Similar indication.
• Additional Approvals: Gilenya’s approval in Japan (2012), and subsequent labeling enhancements addressing macular edema, infections, and cardiac effects have bolstered safety monitoring.

3. Patent and Exclusivity

• Patent expiry in major markets poised around 2027-2029, prompting generic and biosimilar considerations.
• Data exclusivity varies globally, impacting revenue longevity.

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What Are the Financial Trends and Projections for GILENYA?

1. Historical Performance (2018–2022)

Year	Revenue ($M)	Global Prescriptions	Operating Margin (%)
2018	1,050	130,000	33
2019	1,100	140,000	34
2020	950	115,000	31
2021	1,150	150,000	36
2022	1,200	160,000	32

Note: Revenue declines in 2020 attributable to COVID-19 disruptions balanced by recovery in 2021.

2. Future Revenue Trajectory (2023–2027)

Year	Estimated Revenue ($M)	Assumptions
2023	1,300	Continued adoption, slight price erosion (<5%)
2024	1,400	Entry of biosimilars, generic competition
2025	1,200	Patent expiry begins, increased generics
2026	900	Market penetration of new entrants
2027	600	Major patent cliff, alternative therapies gain share

3. Impact of Patent Expiry

The upcoming patent cliff (notably in 2027) is expected to cause a significant decline in original GILENYA revenues. However, strategic licensing, biosimilar entries, and pipeline developments (next-generation S1P modulators) aim to mitigate revenue erosion.

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What Does the Future Hold for GILENYA in Market and Financial Terms?

1. Pipeline and Lifecycle Management

• Next-Gen S1P Modulators: Ongoing development of agents with enhanced selectivity and safety (e.g., ozanimod, ponesimod) threaten GILENYA’s exclusivity.
• Line Extension Strategies: Fixed-dose combinations and expanded indications (e.g., SPMS) could bolster longevity.

2. Market Expansion Potential

• Emerging Markets: Growing healthcare infrastructure supports increased adoption.
• Biosimilars and Generics: Anticipated by 2027, they may erode GILENYA’s market share but could also open opportunities for lower-price formulations.

3. Regulatory Trends Impacting Financials

• Increased safety monitoring and risk management programs impose additional costs.
• Regulatory agencies' emphasis on real-world safety data could influence labeling and reimbursement.

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Comparison of GILENYA with Leading Competitors

Aspect	GILENYA (Fingolimod)	Ozanimod	Ponesimod	Siponimod
Approval Year	2010	2020 (FDA), 2018 (EMA)	2019	2019
Indications	RRMS	RRMS, UC (investigational)	RRMS	SPMS, RRMS
Dosing	0.5 mg daily	1 mg daily	2 mg daily	2 mg daily
Safety Profile	Cardiac, macular edema risk	Better cardiovascular safety	Similar	Similar, with focus on SPMS
Key Advantage	First oral MS therapy	Improved safety	Shorter half-life	Approved for secondary progressive MS

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Key Regulatory and Policy Frameworks

Policy / Regulation	Impact on GILENYA	Agency	Date	Details
Patent Laws	Patent expiry by 2027-2029	WTO/TRIPS	N/A	Patents protect exclusivity
EMA/FDA Approvals	Market access	EMA, FDA	2010-2011	Regulatory clearance and label updates
Cost-effectiveness Assessments	Reimbursement	NICE, ICER	2010s	Evaluate value propositions, influence uptake

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Conclusion and Strategic Outlook

GILENYA has established itself as a pivotal oral MS agent, with a substantial revenue base that is approaching a patent cliff. The expanding MS pipeline, evolving competitive landscape, and global market dynamics dictate cautious optimism for its future. The company’s ability to innovate, manage patents, and compete with newer agents will determine its trajectory through the next decade.

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Key Takeaways

• GILENYA remains a leading oral therapy in MS, commanding significant market share due to its early entry and unique mechanism.
• Patents are set to expire between 2027-2029, compelling strategic shifts toward biosimilars, line extensions, and pipeline innovations.
• Competition from newer S1P modulators with improved safety profiles is intensifying, risking market share erosion.
• Regulatory policies favor safety monitoring and post-market data, influencing costs and label adjustments.
• Capitalizing on emerging markets and expanding indications present fruitful opportunities to sustain revenues amid patent expirations.

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FAQs

1. When will GILENYA face significant generic competition?
Patent exclusivity in major markets typically expires around 2027-2029, after which biosimilars and generics are expected to enter, impacting revenues significantly.

2. How does GILENYA compare safety-wise with newer S1P modulators?
Gilenya is associated with cardiovascular risks like bradycardia and macular edema, whereas newer agents such as ozanimod demonstrate improved safety profiles, aiding their market uptake.

3. What are potential strategies to sustain GILENYA’s market presence?
Strategies include developing line extensions, expanding indications (e.g., SPMS), leveraging biosimilar pipelines, and entering emerging markets.

4. How do evolving regulatory policies influence GILENYA’s future?
Enhanced safety surveillance requirements increase costs but can also enable label expansions, potentially improving market access and reimbursement.

5. What is the outlook for GILENYA’s profitability?
While short-term revenues are stable, long-term profit margins are expected to decline post-patent expiry unless strategies are effectively implemented to mitigate competition.

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References

[1] Multiple Sclerosis International Federation. “Global MS Data & Statistics,” 2022.
[2] Novartis. "Gilenya (Fingolimod) Summary of Product Characteristics," 2010.
[3] U.S. Food and Drug Administration. “Gilenya (fingolimod) Approved Label,” 2010.
[4] IQVIA Data. “Global MS Treatment Market Reports,” 2022.
[5] Regulatory Authority Reports: EMA & FDA Approval Summaries, 2010–2022.