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Last Updated: July 17, 2025

Dimethyl fumarate - Generic Drug Details


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What are the generic drug sources for dimethyl fumarate and what is the scope of patent protection?

Dimethyl fumarate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Torrent, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in eighteen NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has ninety-two patent family members in twenty-nine countries.

There are twenty-eight drug master file entries for dimethyl fumarate. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for dimethyl fumarate

See drug prices for dimethyl fumarate

Recent Clinical Trials for dimethyl fumarate

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

SponsorPhase
Imcyse SAPhase 1/Phase 2
Assistance Publique - Hôpitaux de ParisPhase 2
Xuanwu Hospital, BeijingPhase 2

See all dimethyl fumarate clinical trials

Generic filers with tentative approvals for DIMETHYL FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free240MGCAPSULE, DELAYED RELEASE;ORAL
⤷  Try for Free⤷  Try for Free120MGCAPSULE, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for dimethyl fumarate
Anatomical Therapeutic Chemical (ATC) Classes for dimethyl fumarate
Paragraph IV (Patent) Challenges for DIMETHYL FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TECFIDERA Delayed-release Capsules dimethyl fumarate 120 mg and 240 mg 204063 29 2017-03-27

US Patents and Regulatory Information for dimethyl fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes 11,246,850 ⤷  Try for Free ⤷  Try for Free
Accord Hlthcare DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210499-002 Sep 24, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zydus Pharms DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210538-001 Sep 24, 2020 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Twi Pharms DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210382-002 Oct 14, 2020 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 dimethyl fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 7,320,999 ⤷  Try for Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 8,524,773 ⤷  Try for Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 8,759,393 ⤷  Try for Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 7,803,840 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for dimethyl fumarate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Almirall S.A Skilarence dimethyl fumarate EMEA/H/C/002157
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Authorised no no no 2017-06-23
Biogen Netherlands B.V. Tecfidera dimethyl fumarate EMEA/H/C/002601
Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Authorised no no no 2014-01-30
Mylan Ireland Limited Dimethyl fumarate Mylan dimethyl fumarate EMEA/H/C/005956
Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Authorised yes no no 2022-05-13
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. Dimethyl fumarate Polpharma dimethyl fumarate EMEA/H/C/005955
Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Authorised yes no no 2022-05-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for dimethyl fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0284288 SPC/GB98/002 United Kingdom ⤷  Try for Free PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
2653873 122023000006 Germany ⤷  Try for Free PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837 20140130
2653873 LUC00294 Luxembourg ⤷  Try for Free PRODUCT NAME: DIMETHYL FUMARATE (TECFIDERA); AUTHORISATION NUMBER AND DATE: EU/1/13/837/001-002 20140203
0605697 SPC/GB01/008 United Kingdom ⤷  Try for Free PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Dimethyl Fumarate

Last updated: July 4, 2025

Introduction

Dimethyl fumarate, a cornerstone treatment for multiple sclerosis (MS) and psoriasis, has reshaped the pharmaceutical landscape since its approval. Marketed primarily as Tecfidera by Biogen, this oral medication generates billions in revenue while navigating intense competition and regulatory hurdles. As businesses eye opportunities in the MS market—projected to exceed $30 billion globally by 2028—understanding dimethyl fumarate's dynamics offers critical insights for investors and executives. This analysis dives into its market forces and financial path, equipping professionals with data-driven perspectives.

Overview of Dimethyl Fumarate

Dimethyl fumarate operates as an immunomodulator, reducing inflammation in the central nervous system to manage relapsing-remitting MS and moderate-to-severe plaque psoriasis. First approved by the U.S. Food and Drug Administration (FDA) in 2013, it quickly became a go-to therapy due to its efficacy and convenience over injectables like interferon beta. Biogen holds the primary rights, but generics have emerged in select markets, influencing accessibility and pricing.

The drug's patent landscape remains pivotal. Biogen's core patents for Tecfidera expired in the U.S. in 2020, opening doors for competitors such as Mylan and Dr. Reddy's Laboratories. Despite this, secondary patents and formulations have sustained Biogen's market position, with global sales peaking at over $4.2 billion in 2021 before a gradual decline.

Current Market Dynamics

The market for dimethyl fumarate reflects a blend of robust demand and escalating competition. Valued at approximately $5.5 billion in 2023, it forms a significant segment of the MS therapeutics market, which grows at a compound annual growth rate (CAGR) of 4.5% through 2030.

Key Drivers of Growth

Rising MS prevalence drives demand, with global cases surpassing 2.8 million in 2023, according to World Health Organization estimates. Aging populations and improved diagnostics amplify this trend, particularly in North America and Europe, where dimethyl fumarate captures over 60% of oral MS treatments. Healthcare providers favor it for its safety profile, including a lower risk of infections compared to biologics like ocrelizumab.

Emerging markets in Asia-Pacific, such as China and India, present untapped potential. Here, increasing healthcare spending and regulatory approvals—China's National Medical Products Administration greenlit a generic in 2022—fuel adoption. However, supply chain disruptions and raw material costs have pushed prices up by 10-15% in some regions, challenging affordability.

Competition and Market Share

Biogen dominates with a 70% share in branded dimethyl fumarate sales, but generics erode this edge. In the U.S., competitors like Sandoz entered with lower-cost versions in 2021, slashing Biogen's revenue by 20% in that market. Novartis and Sanofi counter with alternatives like Gilenya and Aubagio, offering similar efficacy at competitive prices, intensifying price wars.

Strategic partnerships enhance market resilience. Biogen's collaborations with distributors in emerging economies help offset losses, while innovations like extended-release formulations aim to differentiate Tecfidera. Yet, biosimilars and pipeline drugs from Johnson & Johnson threaten to capture shares, with J&J's experimental MS therapies in late-stage trials.

Regulatory Environment

Stringent regulations shape dimethyl fumarate's trajectory. The FDA and European Medicines Agency (EMA) mandate ongoing post-market surveillance for side effects, such as gastrointestinal issues and rare cases of progressive multifocal leukoencephalopathy. These requirements increase compliance costs for manufacturers, potentially delaying generic launches.

Globally, patent disputes add complexity. Biogen successfully defended against challenges in Europe, extending exclusivity until 2025 in some countries. Conversely, India's patent office rejected Biogen's claims in 2023, allowing immediate generic entry. Such variances force companies to adapt strategies, balancing innovation with cost control amid evolving intellectual property laws.

Financial Trajectory

Dimethyl fumarate's finances tell a story of peak performance followed by strategic adaptation. Biogen reported peak annual revenues of $4.2 billion for Tecfidera in 2021, driven by strong U.S. sales and international expansion. Since then, figures dipped to $3.8 billion in 2023 as patents lapsed and generics proliferated.

Revenue and Sales History

From 2013 to 2020, dimethyl fumarate enjoyed exponential growth, with sales compounding at 25% annually. This surge stemmed from its FDA approval and subsequent EMA nod, positioning it as a blockbuster. Biogen's net profits from the drug hit $1.5 billion in 2019, bolstered by premium pricing—around $85,000 per patient annually in the U.S.

Post-2020, revenue contracted due to generic competition. In the U.S., generic penetration reached 40% by 2023, eroding Biogen's margins. Internationally, sales in Europe stabilized at €2.5 billion, supported by favorable reimbursement policies. Overall, the drug contributed 15-20% to Biogen's total revenue in recent years, underscoring its financial significance.

Future Projections

Looking ahead, analysts forecast a moderated growth path. Grand View Research projects global dimethyl fumarate sales to reach $6.1 billion by 2030, with a CAGR of 3.5%, fueled by demand in developing markets. Biogen anticipates offsetting declines through cost efficiencies and new indications, such as expanded use in psoriasis, potentially adding $500 million in annual revenue.

However, risks loom. Patent expirations could deepen generic impact, projecting a 15% revenue drop by 2025. Inflation and supply chain issues may raise production costs by 8-10%, squeezing profits. On the upside, Biogen's R&D investments—totaling $1.2 billion in 2023—aim at next-generation therapies, possibly extending dimethyl fumarate's lifecycle.

Impact of Patents and Generics

Patents dictate financial outcomes. Biogen's original composition-of-matter patent expired in 2020, but process patents provide interim protection. This has enabled price adjustments, with Biogen reducing U.S. list prices by 10% in 2022 to retain market share. Generics, priced 70-80% lower, appeal to cost-sensitive payers, yet quality concerns limit their uptake.

Financially, this dynamic pressures Biogen's earnings per share, which fell 5% in 2023. Investors should monitor ongoing lawsuits, such as Biogen's appeal against generic approvals, as outcomes could sway projections by hundreds of millions.

Challenges and Opportunities

Dimethyl fumarate faces headwinds from alternative treatments and economic volatility. Supply shortages, exacerbated by global events, disrupted availability in 2022, impacting sales. Additionally, patient adherence issues—due to side effects—reduce long-term revenue.

Yet, opportunities abound. Expanding into psoriasis markets could double addressable patients, while digital health integrations enhance outcomes and loyalty. For businesses, acquiring generic manufacturers or investing in R&D partnerships offers entry points, potentially yielding high returns in a $30 billion MS ecosystem.

Conclusion

Dimethyl fumarate remains a vital asset in pharmaceuticals, balancing market challenges with financial resilience. As competition intensifies, strategic adaptations will determine its future, guiding informed decisions for stakeholders.

Key Takeaways

  • Dimethyl fumarate's market size reached $5.5 billion in 2023, driven by MS prevalence and oral therapy demand.
  • Biogen's revenues peaked at $4.2 billion in 2021 but face pressure from generics, projecting a 15% decline by 2025.
  • Patent expirations and regulatory shifts create opportunities in emerging markets, with growth potential at 3.5% CAGR through 2030.
  • Competition from players like Novartis intensifies, but innovations could extend product lifecycle.
  • Investors should prioritize R&D and partnerships to mitigate risks in this evolving sector.

FAQs

  1. What factors most influence dimethyl fumarate's market growth? The drug's growth hinges on increasing MS diagnoses and regulatory approvals in new regions, though generics pose a counterbalance.
  2. How has patent expiration affected Biogen's financials? It led to a 20% revenue drop in the U.S. by introducing cheaper alternatives, prompting Biogen to explore new formulations.
  3. What role do emerging markets play in dimethyl fumarate's trajectory? These markets offer untapped demand, potentially offsetting declines in mature regions like North America.
  4. Are there upcoming challenges for dimethyl fumarate investors? Yes, supply chain disruptions and side effect monitoring could increase costs and regulatory scrutiny.
  5. How does dimethyl fumarate compare financially to other MS drugs? It outperforms many in revenue history but lags behind biologics in long-term growth due to generic threats.

Sources

  1. Biogen Annual Report 2023, available on Biogen's investor relations website.
  2. Grand View Research, "Multiple Sclerosis Drugs Market Size, Share & Trends Analysis Report," published 2023.
  3. U.S. Food and Drug Administration, "Tecfidera Approval History," accessed via FDA database.

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