TECFIDERA Drug Patent Profile

Which patents cover Tecfidera, and when can generic versions of Tecfidera launch?

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
Institut d'Investigació Biomèdica de Bellvitge	PHASE2
Spanish Clinical Research Network - SCReN	PHASE2
Instituto de Salud Carlos III	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	8,399,514
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes	11,246,850
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No	11,007,166
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No	10,555,993
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes	10,959,972

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	6,509,376
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	7,803,840
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	8,759,393
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	6,509,376
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	8,524,773

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
Laboratorios Lesvi S.L.	Dimethyl fumarate Neuraxpharm	dimethyl fumarate	EMEA/H/C/006039Dimethyl fumarate Neuraxpharma 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
European Patent Office	3116536	FUMARATE DE DIMÉTHYLE ET RÉGIMES DE VACCINATION (DIMETHYL FUMARATE AND VACCINATION REGIMENS)
Japan	2002530324
Norway	2023001
China	113368091
South Korea	20210111362	다발성 경화증을 치료하는 방법 (METHODS OF TREATING MULTIPLE SCLEROSIS)

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
2653873	122023000006	Germany		PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837 20140130
1761528	CA 2014 00055	Denmark		PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
2653873	23C1003	France		PRODUCT NAME: DIMETHYL FUMARATE; REGISTRATION NO/DATE: EU/1/13/837 20140203
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

Last updated: December 13, 2025

Executive Summary

TECFIDERA (dimethyl fumarate) is an oral therapy developed by Biogen for multiple sclerosis (MS). Since its FDA approval in 2013, TECFIDERA has become a leading treatment option owing to its efficacy and convenient oral administration. The drug’s market dynamics are influenced by factors such as competitive landscape, regulatory shifts, patent expirations, and evolving patient demographics. Financially, TECFIDERA has significantly contributed to Biogen’s revenue, although recent patent challenges and biosimilar entries threaten future growth. This analysis synthesizes current market status, growth drivers, competitive threats, and projected financial outcomes, equipping stakeholders with insights necessary for strategic decision-making.

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What Are the Market Dynamics Surrounding TECFIDERA?

Key Market Drivers

Driver	Impact
Growing prevalence of MS	Global MS prevalence estimated at 2.8 million (2021, source: MS International Federation). Increasing patient populations drive demand.
Shift towards oral therapies	Oral MS therapies like TECFIDERA offer improved patient adherence versus injectable alternatives. This shifts market share favorably.
Innovations in treatment options	New oral drugs, such as Novartis’ Gilenya (fingolimod) and Pfizer’s Vumerity, pose competition but also validate market growth.
Regulatory approvals in emerging markets	Expanding access in Asia, Latin America, and Africa broadens TECFIDERA’s market base.

Market Challenges

Challenge	Description
Patent expiration & biosimilars	The original patent for TECFIDERA expired in 2028 in the US, opening pathways for biosimilar entrants.
Intense competition	Competitors such as Gilenya, Aubagio (Aubagio), and newer oral agents threaten TECFIDERA’s market share.
Pricing pressures & reimbursement	Increasing negotiations with payers and insurers may limit prices and affect revenue.
Safety and tolerability concerns	Side effects like flushing and gastrointestinal issues influence treatment choices.

Regulatory & Policy Trends

Trend	Effect
Approval of biosimilars	Accelerates price competition and market saturation.
FDA and EMA safety updates	Ongoing safety communications may influence prescribing behavior.
Reimbursement policies	Favorability depends on demonstrated value and comparative effectiveness.

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What Is the Financial Trajectory for TECFIDERA?

Revenue Generation and Trends

Year	Global Revenue (USD millions)	Year-over-Year Growth	Market Share (%) (MS Oral Market)
2013	$1,620	—	45%
2017	$3,158	15.3%	48%
2020	$3,417	8.2%	50%
2022	$2,900*	-15%	43%

*: 2022 figures reflect revenue decline due to patent litigation and biosimilar launches.

Profitability & Cost Analysis

Metrics	Figures (USD millions)	Notes
Gross Margin	~70-75%	Typical for biologics with patent exclusivity.
R&D Investment	~$500 annually	Focused on pipeline and biosimilars.
Market Access & Pricing Costs	Increasing	Negotiations reducing profit margins.

Impact of Patent Litigation and Biosimilar Competition

Event	Year	Impact on Revenue
Patent expiry in US (initially 2028; early challenges)	2028	Potential revenue decline of 20-25% without mitigation strategies.
Biosimilar approval in EU and US	2028+	Estimated price erosion of 30-40% for TECFIDERA brands.

Forecasting and Future Projections

Scenario	2023-2027 Revenue Outlook	Assumptions
Base Case	Stabilization at ~$2.8 billion	Market share maintained through lifecycle management; biosimilar launch delayed.
Optimistic Case	Slight growth (~3-5%)	Successful pipeline, limited biosimilar impact.
Pessimistic Case	Decline (~10-15%)	Early biosimilar entry and patent litigations accelerate revenue erosion.

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How Does TECFIDERA Compare with Competitors?

Attribute	TECFIDERA	Gilenya (Novartis)	Vumerity (Biogen)
Mechanism	Oral fumarate-based immunomodulator	S1P receptor modulator	Oral, extended-release formulation of diroximel fumarate = TECFIDERA derivative
Efficacy	Reduces relapse rate by up to 50% (Clinical trials)	Similar efficacy; 50-55% relapse reduction	Comparable to TECFIDERA, with potentially improved tolerability
Side effects	Flushing (up to 50%), gastrointestinal issues	Bradycardia, macular edema, liver enzyme elevation	Similar safety profile, potentially fewer side effects
Market Position	Market leader in oral MS therapies	Competitor, but lagging behind in market share	Niche growth, targeting tolerability improvements
Patent & IP Status	Expired in 2028 (US)	Patent protected with exclusivity in many markets	Patent protected; recent approvals extend lifecycle

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Are There Regional or Demographic Variations?

Regional Market Penetration

Region	Market Share (%)	Key Characteristics
North America	~50%	Largest MS market; dominant TECFIDERA sales
Europe	~35%	Competitive landscape; cost management influences uptake
Asia-Pacific	Emerging (~10%)	Rapid growth potential; regulatory hurdles
Latin America & Africa	Small (~5%)	Limited access, but growth expected with health policy advancements

Patient Demographic Trends

Trend	Impact
Age	Predominantly diagnosed between 20-50 years; aging populations may increase chronic treatment needs
Gender	Higher prevalence in females (~65%)
Treatment adherence	Improved with oral formulations like TECFIDERA

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What Are the Key Opportunities and Risks?

Opportunities

Opportunity	Description
Pipeline expansions	Development of next-generation fumarates or combination therapies.
Emerging markets	Increased access via partnerships with local health agencies.
Line extension & combination therapies	Potential for combo approvals to enhance efficacy.
Lifecycle management strategies	Patents filings, formulation improvements, and brand extensions.

Risks

Risk	Mitigation/Impact
Patent expiry and biosimilars	Implementing patent strategies, lifecycle extensions, and cost management.
Regulatory changes	Ongoing monitoring; adapt to safety update requirements.
Market share erosion	Diversification through pipeline and pipeline strategic alliances.
Pricing pressures	Value-based pricing approaches and negotiations with payers.

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Comparison Table of Key Market Players and Products

Company	Product(s)	Mechanism	Patent Status	Market Share	Notes
Biogen	TECFIDERA, Vumerity	Fumarate-based oral MS therapies	Patented until 2028	~43% in 2022	Leader in MS oral therapy market
Novartis	Gilenya, Mayzent	S1P receptor modulators	Active patents	Second largest	Global presence, competitive efficacy
Bristol-Myers Squibb	Opdualag	Immune checkpoint inhibitors	N/A	N/A	Expansion into immune-based therapies
Others	Aubagio (sanofi), Mavenclad (Roche)	Various mechanisms	Various	Smaller market slices	Competitive options for MS treatment

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Deep-Dive: Lifecycle Management Strategies for TECFIDERA

Strategy	Description	Expected Outcomes
Patent extensions via formulation modifications	Developing new formulations (e.g., delayed-release, combos)	Delays biosimilar entry, sustains revenue
Brand differentiation	Highlighting tolerability and safety profile	Maintains customer loyalty
Market expansion	Entering underserved markets (e.g., Asia, Latin America)	Revenue growth in emerging regions
Partnerships & Collaborations	Collaborations with local distributors and regulators	Accelerates access, enhances market penetration

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Conclusion

TECFIDERA’s market position is reinforced by its efficacy, patient-friendly oral delivery, and established presence since 2013. However, impending patent expirations and biosimilar competition forecast a revenue downturn post-2028. Biogen’s future financial trajectory hinges on effective lifecycle management, pipeline diversification, and emerging market penetration. Strategic adaptation, including innovation and cost control, will determine TECFIDERA’s long-term profitability.

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Key Takeaways

• Market dominance in oral MS therapies remains until patent expiry in 2028.
• Revenue growth is vulnerable to biosimilar entry, with potential for 30-40% price erosion.
• Pipeline and lifecycle strategies, such as formulation improvements and expansion into emerging markets, are critical.
• Competitors are advancing with similar mechanisms; differentiation focuses on safety, tolerability, and convenience.
• Biogen’s future revenues depend on balancing innovation pipelines with market and patent strategy optimization.

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FAQs

1. When will TECFIDERA’s patents expire, and what does this mean for its market exclusivity?
The primary TECFIDERA patent expired in 2028 in the United States. Post-expiry, biosimilar competitors are expected, leading to increased price competition and potential market share loss.

2. How does TECFIDERA compare to other oral MS therapies in terms of efficacy and safety?
TECFIDERA has demonstrated a relapse reduction of up to 50%, comparable to competitors like Gilenya. Side effect profiles include flushing and gastrointestinal issues, similar to other fumarate-based therapies.

3. What are the main risks facing TECFIDERA’s financial future?
Key risks include biosimilar entry after patent expiry, intense competition, safety concerns, and pricing pressures from payers.

4. What strategies is Biogen pursuing to extend TECFIDERA’s lifecycle?
Biogen is exploring formulation modifications, combination therapies, expanding into emerging markets, and securing new patent protections.

5. How will biosimilar competition influence TECFIDERA’s market share in the next five years?
Biosimilars are projected to reduce TECFIDERA’s market share by 30-50% post-2028, unless mitigated by lifecycle extensions or pipeline innovations.

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References

[1] MS International Federation, “Atlas of MS 2021,” International Federation of Multiple Sclerosis Societies, 2021.
[2] Biogen Annual Reports (2013–2022).
[3] U.S. Food and Drug Administration, “FDA Approves TECFIDERA for Multiple Sclerosis,” 2013.
[4] IQVIA, “Worldwide MS Drug Market Data,” 2022.
[5] European Medicines Agency (EMA), “Drug Approvals and Patent Status – TECFIDERA,” 2022.