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Last Updated: July 11, 2025

Fingolimod hydrochloride - Generic Drug Details


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What are the generic drug sources for fingolimod hydrochloride and what is the scope of freedom to operate?

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. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fingolimod hydrochloride
Recent Clinical Trials for fingolimod hydrochloride

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

SponsorPhase
Tang-Du HospitalPhase 1/Phase 2
The Methodist Hospital Research InstitutePhase 2
General Hospital of Shenyang Military RegionPhase 4

See all fingolimod hydrochloride clinical trials

Generic filers with tentative approvals for FINGOLIMOD HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for FreeEQ 0.5MG BASECAPSULE;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
Medical Subject Heading (MeSH) Categories for fingolimod hydrochloride
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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Prinston Inc FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208003-001 Sep 7, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mylan FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208005-001 Jan 19, 2021 AB RX No No ⤷  Try for Free ⤷  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 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 ⤷  Try for Free ⤷  Try for Free
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Try for Free ⤷  Try for Free
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fingolimod hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0627406 1190015-6 Sweden ⤷  Try for Free PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Fingolimod Hydrochloride

Last updated: July 5, 2025

Fingolimod Hydrochloride, marketed as Gilenya by Novartis, stands as a pivotal player in the multiple sclerosis (MS) treatment landscape. This analysis delves into its market dynamics and financial trajectory, offering insights for business professionals navigating pharmaceutical investments. By examining patent status, competitive forces, revenue trends, and future projections, stakeholders can make informed decisions in a sector marked by innovation and regulatory challenges.

Overview of Fingolimod Hydrochloride

Fingolimod Hydrochloride is an oral immunomodulator approved for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. First launched in 2010, it works by sequestering lymphocytes in lymph nodes, reducing their infiltration into the central nervous system and thereby mitigating disease progression. As the first oral disease-modifying therapy for MS, it revolutionized treatment by offering a convenient alternative to injectables like interferon beta.

The drug's approval by the U.S. Food and Drug Administration (FDA) in 2010 stemmed from robust clinical trials demonstrating efficacy in reducing relapse rates by up to 54% compared to placebo. Globally, it has gained traction in over 90 countries, driven by the rising prevalence of MS, which affects approximately 2.8 million people worldwide. This positions Fingolimod as a cornerstone in the MS market, valued at over $25 billion annually, with projections for continued expansion.

Patent Landscape and Regulatory Framework

Patents form the backbone of Fingolimod's market exclusivity, shielding it from generic competition and sustaining revenue streams. Novartis secured the original composition-of-matter patent for Fingolimod in the early 2000s, with key protections extending until 2019 in the U.S. and similar timelines in Europe and other regions. A pediatric exclusivity extension pushed the U.S. patent expiration to 2027 for certain formulations, allowing Novartis to maintain pricing power.

However, legal battles have shaped this landscape. In 2019, the FDA approved the first generic version by companies like Mylan, following patent challenges under the Hatch-Waxman Act. This triggered a wave of abbreviated new drug applications (ANDAs), eroding Novartis's monopoly. Regulatory hurdles, including post-marketing commitments for cardiovascular monitoring due to rare side effects like bradycardia, have further influenced market dynamics. Agencies like the European Medicines Agency (EMA) have imposed similar requirements, impacting adoption rates.

Biosimilar threats remain minimal since Fingolimod is a small molecule, not a biologic, but ongoing patent litigations—such as those resolved in 2021—highlight the drug's vulnerability. Novartis's strategy involves defensive patents on new formulations, ensuring incremental protection and potential licensing deals that could generate additional revenue.

Market Dynamics

The MS treatment market exhibits robust growth, propelled by demographic shifts and advancing diagnostics. Fingolimod captures a 15-20% share in the oral MS segment, competing against heavyweights like Biogen's Tecfidera and Roche's Ocrevus. Demand surges in regions with high MS incidence, such as North America and Europe, where healthcare systems prioritize long-term therapies.

Pricing dynamics play a critical role. In the U.S., Fingolimod's list price hovers around $115,000 annually per patient, though rebates and negotiations with payers reduce net realizations. This has sparked debates on affordability, with value-based pricing models emerging in markets like the UK. Competition intensifies as generics erode premiums; for instance, post-2019, generic penetration reached 40% in the U.S., compressing margins.

Global supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily hampered distribution, but recovery has been swift. Emerging markets in Asia-Pacific offer growth opportunities, with approvals in countries like China driving a 10% annual increase in patient access. Regulatory approvals for expanded indications, such as pediatric MS in 2018, further bolster demand.

Challenges include safety concerns and substitution risks. Real-world data from pharmacovigilance studies indicate a slight uptick in infections among users, prompting cautious prescribing. Competitors like Sanofi's Aubagio gain ground through differentiated safety profiles, illustrating how innovation dictates market share.

Financial Trajectory

Fingolimod's financial performance reflects the pharmaceutical industry's volatility. From 2010 to 2020, global sales peaked at over $3 billion annually for Novartis, driven by rapid uptake in MS care. In 2021, revenues dipped to $2.5 billion due to generic entries, yet Novartis reported a 5% year-over-year growth in emerging markets, offsetting declines in mature ones.

Profit margins remain strong, averaging 75% before generics, thanks to high barriers to entry and scalable manufacturing. Novartis's earnings reports, such as those filed with the SEC, show that Fingolimod contributed significantly to the company's neuroscience division, which generated $9 billion in 2022 revenues. Cost efficiencies, including optimized production at facilities in Switzerland, have sustained profitability despite pricing pressures.

Looking at trends, quarterly data from 2023 indicates a stabilization, with U.S. sales rebounding by 8% as branded versions retain loyalty among specialists. Financial forecasts from industry analysts predict a compound annual growth rate (CAGR) of 3-5% through 2030, assuming no major patent losses. However, net present value (NPV) calculations, based on discounted cash flow models, suggest a potential 20% revenue drop by 2025 due to increased generic adoption.

Strategic alliances, like Novartis's partnerships with distributors in Latin America, enhance financial resilience. Dividend payouts and stock performance correlate positively with Fingolimod's sales, making it a bellwether for investor sentiment in biotech.

Future Outlook

The trajectory for Fingolimod hinges on innovation and market adaptation. As patents wane, Novartis explores combination therapies, such as trials pairing Fingolimod with anti-CD20 monoclonal antibodies, to extend its lifecycle. Market projections from IQVIA estimate the global MS drug market to reach $35 billion by 2028, with Fingolimod maintaining a niche through value-added services like patient support programs.

Emerging threats include novel therapies like BTK inhibitors from Merck, which could capture market share with superior efficacy. Conversely, opportunities arise in personalized medicine, where genetic biomarkers might optimize Fingolimod's use, potentially unlocking premium pricing. Regulatory reforms, such as the Inflation Reduction Act in the U.S., may cap prices, but international expansions could counterbalance this.

Sustainability factors, including environmental impacts of drug production, are gaining attention. Novartis's commitment to green manufacturing could differentiate Fingolimod in eco-conscious markets, fostering long-term growth.

Conclusion

In summary, Fingolimod Hydrochloride's market dynamics and financial trajectory underscore the interplay of innovation, regulation, and competition in pharmaceuticals. While patent expirations pose challenges, strategic maneuvers by Novartis position the drug for sustained relevance in MS treatment.

Key Takeaways

  • Patent protections have extended Fingolimod's exclusivity, but generics are reshaping market share.
  • Revenue streams remain robust in emerging markets despite U.S. declines.
  • Competition from advanced therapies could limit growth, yet expansions in indications offer upside potential.
  • Pricing pressures and regulatory scrutiny demand adaptive strategies for long-term profitability.
  • Investors should monitor global MS trends and Novartis's pipeline for informed decisions.

FAQs

  1. What factors are driving the demand for Fingolimod Hydrochloride? Demand stems from its efficacy in MS treatment and convenience as an oral option, amplified by rising MS diagnoses in aging populations.
  2. How have generic entries affected Fingolimod's financials? Generics have reduced revenues by approximately 20% since 2019, compelling Novartis to focus on cost efficiencies and new markets for stabilization.
  3. What role do patents play in Fingolimod's market dynamics? Patents have delayed competition, but expirations enable generics, intensifying price competition and eroding margins.
  4. Are there upcoming challenges for Fingolimod's future trajectory? Yes, emerging therapies and regulatory price controls pose risks, though expanded uses and partnerships could mitigate these.
  5. How does Fingolimod compare financially to other MS drugs? It generated over $2.5 billion in recent sales, but competitors like Ocrevus have seen faster growth due to broader indications and less generic pressure.

Sources

  1. U.S. Food and Drug Administration. "Gilenya Approval Letter." FDA.gov, accessed 2023.
  2. Novartis AG. "Annual Financial Report 2022." Novartis.com, 2023.
  3. IQVIA Institute. "Global Use of Medicines Outlook to 2028." IQVIA.com, 2023.

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