Dimethyl fumarate - Generic Drug Details

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.

Summary for dimethyl fumarate

International Patents:	92
US Patents:	9
Tradenames:	2
Applicants:	18
NDAs:	18
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	71
Patent Applications:	5,478
Drug Prices:	Drug price trends for dimethyl fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dimethyl fumarate
What excipients (inactive ingredients) are in dimethyl fumarate?	dimethyl fumarate excipients list
DailyMed Link:	dimethyl fumarate at DailyMed

See drug prices for dimethyl fumarate

Recent Clinical Trials for dimethyl fumarate

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

Sponsor	Phase
Imcyse SA	Phase 1/Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 2
Xuanwu Hospital, Beijing	Phase 2

See all dimethyl fumarate clinical trials

Generic filers with tentative approvals for DIMETHYL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		240MG	CAPSULE, DELAYED RELEASE;ORAL
		120MG	CAPSULE, 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

Dermatologic Agents

Immunosuppressive Agents

Radiation-Sensitizing Agents

Anatomical Therapeutic Chemical (ATC) Classes for dimethyl fumarate

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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
Accord Hlthcare	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210499-002	Sep 24, 2020	AB	RX	No	No
Zydus Pharms	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210538-001	Sep 24, 2020		DISCN	No	No
Twi Pharms	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210382-002	Oct 14, 2020	AB	RX	No	No

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
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	8,524,773
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	8,759,393
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	7,803,840

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

International Patents for dimethyl fumarate

Country	Patent Number	Title	Estimated Expiration
South Korea	102299842
Slovenia	2137537
Australia	2018229422	Dimethyl fumarate and vaccination regimens
China	113368091	治疗多发性硬化的方法 (Methods of treating multiple sclerosis)

Supplementary Protection Certificates for dimethyl fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0284288	SPC/GB98/002	United Kingdom		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		PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837 20140130
2653873	LUC00294	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE (TECFIDERA); AUTHORISATION NUMBER AND DATE: EU/1/13/837/001-002 20140203
0605697	SPC/GB01/008	United Kingdom		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

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.