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Last Updated: April 30, 2025

GILENYA Drug Patent Profile


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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.

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Drug patent expirations by year for GILENYA
Drug Prices for GILENYA

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Recent Clinical Trials for GILENYA

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

SponsorPhase
The Methodist Hospital Research InstitutePhase 2
Hikma Pharmaceuticals LLCPhase 1
Genuine Research Center, EgyptPhase 1

See all GILENYA clinical trials

Pharmacology for GILENYA
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 ⤷  Try for Free Y ⤷  Try for Free
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes 10,543,179 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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

Patent: 5749
Patent: FORMULACIONES
Estimated Expiration: ⤷  Try for Free

Patent: 4661
Patent: FORMULACIONES
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 12236357
Patent: Formulations comprising 2 -amino- 2- [2- (4 - octylphenyl) ethyl] propane -1, 3 - diol
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2013024430
Patent: formulações compreendendo 2-amino-2-[2-(4-octilfenil)etil]propano-1,3-diol
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 31600
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 13002810
Patent: 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.
Estimated Expiration: ⤷  Try for Free

China

Patent: 3476400
Patent: Formulations comprising 2-amino-2-[2-(4 - octylphenyl) ethyl] propane -1, 3-diol
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 71459
Patent: Formulaciones que comprenden 2-amino-2-[2- (4-octil-fenil)-etil] -propano-1,3-diol
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0170021
Estimated Expiration: ⤷  Try for Free

Patent: 0200249
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 18423
Estimated Expiration: ⤷  Try for Free

Patent: 22868
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 94037
Estimated Expiration: ⤷  Try for Free

Patent: 43990
Estimated Expiration: ⤷  Try for Free

Ecuador

Patent: 13012912
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 7721
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷  Try for Free

Patent: 5686
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷  Try for Free

Patent: 1391442
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ
Estimated Expiration: ⤷  Try for Free

Patent: 1790436
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 94037
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷  Try for Free

Patent: 43990
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷  Try for Free

Guatemala

Patent: 1300227
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-(2-(4-OCTIL-FENIL)-ETIL)-PROPANO-1,3-DIOL
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 90309
Patent: 包含 -氨基- -辛基苯基 乙基 丙- -二醇的製劑 (FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL]PROPANE - 1, 3 - DIOL 2--2-[2-(4-)]-13-)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 31286
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 8250
Patent: תכשירים המכילים 2-אמינו-2-[2-(4-אוקטילפניל)אתיל]פרופאנ-1,3-דיול (Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 19101
Estimated Expiration: ⤷  Try for Free

Patent: 14509652
Estimated Expiration: ⤷  Try for Free

Jordan

Patent: 77
Patent: تركيبات تتالف من 2-أمينو-2- [ 2- ( 4- أكتيل فينيل ) إثيل ] بروبان - 3, 1- ديول (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 94037
Estimated Expiration: ⤷  Try for Free

Patent: 43990
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 3746
Patent: FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL
Estimated Expiration: ⤷  Try for Free

Patent: 5633
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 2522
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2- (4-OCTIL-FENIL) -ETIL] -PROPANO-1, 3-DIOL. (FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL.)
Estimated Expiration: ⤷  Try for Free

Patent: 13011415
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2- (4-OCTIL-FENIL) -ETIL] -PROPANO-1, 3-DIOL. (FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL.)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 981
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-2-4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 5023
Patent: Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Estimated Expiration: ⤷  Try for Free

Peru

Patent: 140162
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷  Try for Free

Patent: 170913
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 94037
Estimated Expiration: ⤷  Try for Free

Patent: 43990
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 94037
Estimated Expiration: ⤷  Try for Free

Patent: 43990
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 917
Patent: 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)
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 3256
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 94037
Estimated Expiration: ⤷  Try for Free

Patent: 43990
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1306636
Patent: FORMULAIONS COMPRISING 2 -AMINO- 2-[2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 2027014
Estimated Expiration: ⤷  Try for Free

Patent: 140014194
Patent: FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 10966
Estimated Expiration: ⤷  Try for Free

Patent: 73482
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 28958
Estimated Expiration: ⤷  Try for Free

Patent: 1244711
Patent: Formulations
Estimated Expiration: ⤷  Try for Free

Tunisia

Patent: 13000396
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 2857
Patent: ПРЕПАРАТ, ЩО МІСТИТЬ 2-АМІНО-2-[2-(4-ОКТИЛФЕНІЛ)ЕТИЛ]ПРОПАН-1,3-ДІОЛ
Estimated Expiration: ⤷  Try for Free

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 ⤷  Try for Free
European Patent Office 2959894 MODULATEURS DU RÉCEPTEUR S1P POUR TRAITER LA SCLÉROSE EN PLAQUES (S1P RECEPTOR MODULATORS FOR TREATING MULTIPLE SCLEROSIS) ⤷  Try for Free
Spain 2887042 ⤷  Try for Free
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) ⤷  Try for Free
Ukraine 112857 ПРЕПАРАТ, ЩО МІСТИТЬ 2-АМІНО-2-[2-(4-ОКТИЛФЕНІЛ)ЕТИЛ]ПРОПАН-1,3-ДІОЛ ⤷  Try for Free
Tunisia 2013000396 FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL ⤷  Try for Free
Japan 6931019 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GILENYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 2011C/030 Belgium ⤷  Try for Free PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
1613288 28/2011 Austria ⤷  Try for Free PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317
0627406 C00627406/01 Switzerland ⤷  Try for Free FORMER REPRESENTATIVE: BOHEST AG, CH
0627406 1190015-6 Sweden ⤷  Try for Free PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
0627406 CA 2011 00015 Denmark ⤷  Try for Free
1613288 C 2011 005 Romania ⤷  Try for Free 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 ⤷  Try for Free PERIOD OF VALIDITY (FROM - UNTIL): 20240407 - 20260321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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