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. Twenty 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:	139
Clinical Trials:	32
Patent Applications:	389
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
The Methodist Hospital Research Institute	Phase 2
Hikma Pharmaceuticals LLC	Phase 1
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	9,592,208*PED				Y
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes	10,543,179

Expired US Patents for GILENYA

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

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
Denmark	3143990
European Patent Office	2959894	MODULATEURS DU RÉCEPTEUR S1P POUR TRAITER LA SCLÉROSE EN PLAQUES (S1P RECEPTOR MODULATORS FOR TREATING MULTIPLE SCLEROSIS)
Spain	2887042
Serbia	59917	FORMULACIJE KOJE SADRŽE 2-AMINO-2-[2-(4-OKTILFENIL)ETIL]PROPAN-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Ukraine	112857	ПРЕПАРАТ, ЩО МІСТИТЬ 2-АМІНО-2-[2-(4-ОКТИЛФЕНІЛ)ЕТИЛ]ПРОПАН-1,3-ДІОЛ
Tunisia	2013000396	FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Japan	6931019

Supplementary Protection Certificates for GILENYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	2011C/030	Belgium		PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
1613288	28/2011	Austria		PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317
0627406	C00627406/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0627406	1190015-6	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
0627406	CA 2011 00015	Denmark
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	1190025-5	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240407 - 20260321

Market Dynamics and Financial Trajectory for GILENYA

Introduction to GILENYA

GILENYA (fingolimod) is a sphingosine 1-phosphate receptor modulator used in the treatment of multiple sclerosis (MS), a chronic and often disabling autoimmune disease. Developed by Novartis, GILENYA has been a significant player in the MS drugs market since its approval in 2010.

Market Size and Growth

The multiple sclerosis drugs market, within which GILENYA operates, has been experiencing robust growth. As of 2023, the global MS drugs market was valued at approximately $29.66 billion and is projected to grow to $31.5 billion in 2024, with a compound annual growth rate (CAGR) of 6.2%[1].

GILENYA's Role in the Market

GILENYA is one of the key oral therapies in the MS treatment landscape. It has been a major contributor to Novartis's revenue, particularly in the early years following its launch. However, recent trends indicate that while GILENYA remains a significant product, its sales have been impacted by several factors.

Sales Performance

In recent years, Novartis has reported mixed results for GILENYA. The drug's sales have faced challenges due to increased competition from newer therapies and generic alternatives. For instance, in the Q4 2023 financial report, Novartis mentioned that sales in the US were partly offset by generic competition for Lucentis and GILENYA[5].

Competitive Landscape

The MS drugs market is highly competitive, with several major pharmaceutical companies like Biogen, Novartis, and others vying for market share. GILENYA competes directly with other oral and infusion therapies. The market is driven by advances in drug development, increasing prevalence of MS, and growing awareness of the disease[3].

Impact of Generic Competition

Generic competition has been a significant factor affecting GILENYA's sales. The expiration of patents and the entry of generic versions of fingolimod have reduced the drug's market share. This trend is expected to continue, impacting GILENYA's financial performance in the coming years[5].

Geographical Performance

GILENYA's sales performance varies by region. In emerging markets, Novartis has seen growth driven by increased accessibility and government initiatives to improve healthcare. However, in mature markets like the US and Europe, the drug faces intense competition and pricing pressures[5].

Financial Trajectory

Novartis's financial reports indicate that while GILENYA remains a profitable drug, its contribution to the company's overall revenue is diminishing due to the aforementioned factors. Here are some key financial highlights:

• Revenue Growth: Despite the challenges, Novartis's overall net sales grew by 10% (constant currency) in 2023, driven by strong performance from other products like Entresto, Kesimpta, and Pluvicto. However, GILENYA's specific sales figures have not kept pace with these newer products[2].
• Operating Income: Novartis's operating income increased by 39% (constant currency) in 2023, but this growth was largely driven by other successful products rather than GILENYA[2].
• Market Share: The market share of GILENYA is expected to decline as newer therapies and generic versions gain traction. This shift is part of the broader trend in the MS drugs market, where innovation and cost-effectiveness are key drivers of market share[3].

Strategic Moves by Novartis

To mitigate the impact of declining GILENYA sales, Novartis has been focusing on other areas:

• Diversification: Novartis has diversified its portfolio with successful drugs like Entresto, Kesimpta, and Pluvicto, which have shown significant growth[2].
• Innovation: The company continues to invest in research and development to bring new therapies to the market, ensuring a robust pipeline of future products[2].
• Geographical Expansion: Novartis is expanding its reach in emerging markets, where there is a growing demand for MS treatments and fewer generic competitors[5].

Future Outlook

The future outlook for GILENYA is mixed. While it will continue to be a part of the MS treatment landscape, its sales are expected to decline as the market becomes more competitive.

• Market Trends: The MS drugs market is expected to grow, driven by increasing prevalence, advances in drug development, and growing awareness. However, GILENYA's share in this growing market is likely to decrease[1][3][4].
• Competitive Pressure: The entry of new therapies, including biosimilars and generic versions, will continue to pressure GILENYA's sales. Companies like Biogen and Novartis are focusing on innovative and patient-centric care, which may further erode GILENYA's market share[1][3].

Key Takeaways

• GILENYA remains a significant but declining player in the MS drugs market.
• Generic competition and new therapies are major challenges facing GILENYA.
• Novartis's diversification and innovation efforts are crucial for maintaining market presence.
• Emerging markets offer growth opportunities, but mature markets face intense competition.

FAQs

Q: What is GILENYA used for? A: GILENYA (fingolimod) is used in the treatment of multiple sclerosis (MS), a chronic autoimmune disease.

Q: How has GILENYA's sales performance been in recent years? A: GILENYA's sales have faced challenges due to generic competition and the rise of newer therapies, leading to a decline in its market share.

Q: What are the key factors affecting the MS drugs market? A: The MS drugs market is driven by increasing prevalence, advances in drug development, growing awareness, and government initiatives to improve healthcare.

Q: How is Novartis addressing the decline in GILENYA sales? A: Novartis is diversifying its portfolio with successful new drugs, investing in R&D, and expanding its reach in emerging markets.

Q: What is the future outlook for GILENYA in the MS drugs market? A: GILENYA's sales are expected to decline as the market becomes more competitive with new therapies and generic versions entering the market.

Cited Sources

1. The Business Research Company: Multiple Sclerosis Drugs Market Analysis and Industry Insights.
2. Novartis: Novartis Financial Results Q4 2023 – English.
3. SkyQuest: Multiple Sclerosis Drugs Market Analysis, Size, Share & Trends | 2031.
4. GlobeNewswire: Multiple Sclerosis Drugs Market Outlook and Strategic Business Report 2024-2030.
5. Novartis: Novartis Q4 2023 Condensed Financial Report – Supplementary Data.