TECFIDERA Drug Patent Profile

When do Tecfidera patents expire, and what generic alternatives are available?

Tecfidera is a drug marketed by Biogen Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in twenty-nine countries.

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tecfidera

A generic version of TECFIDERA was approved as dimethyl fumarate by MYLAN on August 17^th, 2020.

Summary for TECFIDERA

International Patents:	94
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	58
Drug Prices:	Drug price information for TECFIDERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TECFIDERA
What excipients (inactive ingredients) are in TECFIDERA?	TECFIDERA excipients list
DailyMed Link:	TECFIDERA at DailyMed

See drug prices for TECFIDERA

Recent Clinical Trials for TECFIDERA

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

Sponsor	Phase
Spanish Clinical Research Network - SCReN	PHASE2
Instituto de Salud Carlos III	PHASE2
Pujol, Aurora, M.D.	PHASE2

See all TECFIDERA clinical trials

Paragraph IV (Patent) Challenges for TECFIDERA

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 TECFIDERA

TECFIDERA is protected by nine US patents.

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	204063-001	Mar 27, 2013	AB	RX	Yes	No
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No

Expired US Patents for TECFIDERA

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
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013

EU/EMA Drug Approvals for TECFIDERA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Almirall S.A	Skilarence	dimethyl fumarate	EMEA/H/C/002157Skilarence 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/002601Tecfidera 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/005956Dimethyl 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/005955Dimethyl 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 TECFIDERA

See the table below for patents covering TECFIDERA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2025109834	METHODS FOR TREATING MULTIPLE SCLEROSIS
Israel	269885
China	1615839
Spain	2916649

Supplementary Protection Certificates for TECFIDERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1131065	92488	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
2137537	2014C/039	Belgium		PRODUCT NAME: DIMETHYL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/13/837/001 20140203
2653873	122023000006	Germany		PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837 20140130
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

Market Dynamics and Financial Trajectory for Tecfidera (Dimethyl Fumarate)

Last updated: November 20, 2025

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Introduction

Tecfidera (dimethyl fumarate) is a leading oral disease-modifying therapy (DMT) approved for relapsing forms of multiple sclerosis (MS). Since its launch in 2013 by Biogen Idec, Tecfidera has significantly impacted the MS treatment landscape, driven by its unique oral administration and efficacy profile. This article examines the evolving market dynamics and financial trajectory of Tecfidera within the context of competitive pressures, evolving regulatory and healthcare landscapes, and emerging pipeline developments.

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Market Overview

Global Multiple Sclerosis Treatment Market

The global MS therapeutics market is projected to reach approximately USD 28 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 5-6% [1]. The rise is driven by increasing prevalence, greater diagnosis rates, and a strong pipeline of innovative therapies. Among these, oral agents like Tecfidera have gained significant market share due to their convenience over injectable therapies.

Therapeutic Positioning and Market Share

Tecfidera pioneered the oral MS treatment segment, initially capturing a sizeable proportion of the market. By 2020, it held a dominant position with a market share exceeding 25% in the U.S., surpassing traditional injectable therapies such as interferon beta formulations [2]. Nevertheless, competition has intensified with the entry of newer oral DMTs and biosimilars.

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Market Dynamics Influencing Tecfidera

Competitive Landscape

Emergence of New Oral DMTs
The competitive landscape features Roche’s Ocrevus (ocrelizumab), Novartis’s Mayzent (siponimod), and Bayer’s Vumerity, among others [3]. These drugs offer comparable or improved efficacy profiles, often with favorable safety and tolerability, challenging Tecfidera’s market dominance.

Biosimilars and Next-Generation Therapies
Although Tecfidera's active ingredient is a small molecule, the broader landscape sees biosimilar competition and transformational therapies such as anti-CD20 antibodies, which threaten market share. The recent patent expiry waves for older injectable therapies further shift focus toward newer oral options.

Regulatory Environment and Patent Landscape

Biogen’s patent protections for Tecfidera are expiring in key markets, including the U.S. and EU, around 2024–2026 [4]. This opens pathways for generic manufacturers to enter the market, likely inducing significant price erosion and revenue decline. The company has pursued patent extensions and hesitated to launch legal challenges, but inevitable generic entry remains a major market dynamic.

Pricing and Reimbursement Trends

Pricing pressures are intensifying globally. Payers increasingly favor cost-effective therapies, often favoring generics or biosimilars once patent protections lapse. Biogen’s strategy to negotiate rebates and offer patient assistance programs aims to sustain Tecfidera’s market share amid these pressures.

Patient Preferences and Adherence

The oral administration route remains a key differentiator. Tecfidera’s side effect profile, primarily flushing and gastrointestinal discomfort, has affected adherence but remains manageable with proper management strategies. Real-world adherence data favor oral DMTs, reinforcing Tecfidera’s role [5].

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Financial Trajectory Analysis

Revenue Trends and Forecasts

Historical Revenue Performance
Tecfidera generated approximately USD 4.8 billion globally in 2020, marking it as Biogen’s top-selling product at that time. The 2021 revenues declined slightly due to generic competition, with estimates around USD 4.3 billion [6].

Future Revenue Outlook
Analysts predict a gradual revenue decline starting 2024–2025, aligning with patent expirations, unless Biogen successfully maintains market share through line extensions or new indications. However, the anticipated launch of biosimilars is expected to accelerate revenue erosion.

Impact of Patent Expiry and Generic Entry

Based on industry patterns, generic entry typically causes a 60-80% reduction in prices within the first year of entry [7]. For Tecfidera, revenue could decline by 40-50% over 2–3 years post-patent expiry if biosimilar penetration is robust. Biogen’s strategies include portfolio diversification and pipeline expansion to mitigate this impact.

Pipeline and Future Developments

Biogen is developing next-generation formulations, such as optimized oral DMTs (e.g., Vumerity), and exploring remyelination agents. These efforts aim to extend the company's MS portfolio and offset Tecfidera’s revenue decline.

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Strategic Implications and Market Opportunities

Market Expansion and New Indications

Expanding indications, for example, in pediatric MS or secondary progressive MS, can enhance Tecfidera’s revenue potential. Additionally, entering emerging markets with high unmet needs offers growth opportunities.

Pipeline Innovations

Innovation in formulations to reduce side effects, improve adherence, and extend dosing intervals could sustain Tecfidera’s appeal. Additionally, combination therapies and biomarkers for personalized treatment may redefine its market role.

Partnerships and Licensing

Collaborations with generic manufacturers and licensees can facilitate early market entry in biosimilar markets, providing revenue streams despite patent challenges.

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Conclusion

Tecfidera’s market dynamics are shaped by patent expiries, increasing competition, pricing pressures, and evolving therapeutic options. While currently a dominant oral therapy, its financial trajectory faces headwinds from generic entry and pipeline challenges. Nevertheless, strategic diversification, pipeline innovation, and market expansion can mitigate declines and sustain long-term value. Executives should monitor patent landscapes, competitive actions, and regulatory developments to navigate the shifting landscape effectively.

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Key Takeaways

• Tecfidera remains a significant contributor to Biogen’s revenue but faces imminent patent expiration from 2024 onwards.
• Emerging competitors and biosimilars will impose substantial price and market share pressures.
• Strategic pipeline investment and market expansion are vital for maintaining long-term revenue streams.
• Real-world adherence remains favorable but management of side effects remains critical.
• Proactive patent strategies and alliances with generic manufacturers may optimize revenue during patent cliffs.

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FAQs

1. When does Tecfidera’s patent protection expire, and what are the implications?
Patent protections in key markets are expiring between 2024 and 2026, opening the market for biosimilars and generics, which likely lead to a substantial revenue decline for Biogen.

2. What are Tecfidera’s main competitors in the MS market?
Competitors include Ocrevus (Roche), Mayzent (Novartis), Vumerity (Biogen), and the emerging generics, all offering similar or improved efficacy profiles with different safety and administration features.

3. How does Tecfidera’s safety profile impact its marketability?
While generally well tolerated, side effects such as flushing and gastrointestinal discomfort influence adherence. Management strategies help sustain its market position.

4. What strategies can Biogen employ to extend Tecfidera’s market life?
Biogen can pursue indication extensions, optimize formulations, develop combination therapies, and form strategic alliances to prolong revenue streams.

5. How might emerging pipeline therapies influence Tecfidera’s future?
Innovations aimed at remyelination and neuroprotection could redefine therapeutic standards, potentially diminishing Tecfidera’s prominence unless it adapts accordingly.

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References

1. MarketsandMarkets, "Multiple Sclerosis (MS) Drugs Market," 2021.
2. EvaluatePharma. "Global Multiple Sclerosis Market Review," 2022.
3. Biogen corporate reports, 2022.
4. U.S. Patent and Trademark Office, "Tecfidera Patent Expiry," 2023.
5. Novartis Reports, "Real-world Adherence Trends in MS," 2022.
6. Biogen Annual Report, 2021.
7. IQVIA Institute, "Drug Patent Expiry Impact Analysis," 2020.