TECFIDERA Drug Patent Profile

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

Tecfidera is a drug marketed by Biogen 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. Twenty 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 ACCORD HLTHCARE on September 24^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
Instituto de Salud Carlos III	PHASE2
Pujol, Aurora, M.D.	PHASE2
Institut d'Investigació Biomèdica de Bellvitge	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	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes

Expired US Patents for TECFIDERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013
Biogen	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013
Biogen	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
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
Teva GmbH	Dimethyl fumarate Teva	dimethyl fumarate	EMEA/H/C/005963Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).	Authorised	yes	no	no	2022-12-12
Accord Healthcare S.L.U.	Dimethyl fumarate Accord	dimethyl fumarate	EMEA/H/C/005950Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).	Authorised	yes	no	no	2023-02-15

International Patents for TECFIDERA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2016244325
Australia	2018229422
Australia	2020213345
Australia	2022221548
Canada	2942690
European Patent Office	3116536
European Patent Office	3650042

Supplementary Protection Certificates for TECFIDERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0300652	SPC/GB03/005	United Kingdom		PRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830
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
1131065	C300675	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
1131065	CA 2014 00036	Denmark		PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
1131065	PA2014023	Lithuania		PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
1131065	92488	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
2137537	C300674	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130

Market Dynamics and Financial Trajectory for Tecfidera

Last updated: March 18, 2026

What is Tecfidera and its approved indications?

Tecfidera (dimethyl fumarate) is an oral disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) in 2013. It treats relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). It is marketed by Biogen Idec.

How does the global multiple sclerosis treatment market influence Tecfidera?

The MS therapeutics market, valued at approximately $22.1 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2028 [1]. Key drivers include rising MS prevalence, expanding diagnosis rates, and increased adoption of oral therapies. Tecfidera captures a significant share of the oral MS segment, which is growing faster than injectable therapies.

What are Tecfidera's market share and revenue figures?

Biogen reported Tecfidera revenue of approximately $2.49 billion in 2022, accounting for 44% of its total product sales [2]. Sales experienced a peak of $4.2 billion in 2018 before declining due to patent litigation and competition.

Revenue trend (2018–2022):

Year	Revenue (USD billion)	Percentage of total sales
2018	4.2	50%
2019	3.7	45%
2020	3.4	43%
2021	2.9	44%
2022	2.49	44%

Note: Revenue decline partly due to biosimilars and generics entering markets post patent expiry.

How does patent protection and generic competition impact Tecfidera?

The primary patent covering Tecfidera in the U.S. expired in March 2023, opening the door for generics. Biogen engaged in patent litigation, delaying generics' entrance until 2023. Once patent exclusivity fully lapses, generic versions are expected to significantly reduce Tecfidera's market share and revenue.

Patent expiry timeline:

Patent	Expiration Date	Impact on Tecfidera
U.S. patent	March 2023	Entry of generics likely to reduce revenue substantially
Additional patents	2025–2027	Potentially extend market exclusivity through secondary patents

What are the competitive pressures affecting Tecfidera?

Biosimilar and generic competition from products like Dimethyl fumarate (Mylan) and other MS therapies threaten Tecfidera's market dominance [3]. Other oral MS treatments such as Aubagio (teriflunomide) and Gilenya (fingolimod) maintain market share through differing mechanisms, but Tecfidera's market share has declined from over 50% in 2018 to approximately 30% in 2022 [4].

Are there pipeline developments or off-label uses influencing the outlook?

Biogen continues to explore new indications for Tecfidera, including progressive MS forms. Ongoing clinical trials evaluate its efficacy in other autoimmune diseases. The company is also developing next-generation fumarate derivatives to improve safety and efficacy.

How do regulatory changes and reimbursement policies impact Tecfidera?

Reimbursement policies vary globally, affecting access and sales volume. In the U.S., insurance coverage is generally favorable, but cost-sharing remains a barrier for some patients. Internationally, pricing and formulary inclusion influence sales, with some markets favoring generics, reducing Tecfidera's competitive advantage.

What is the financial outlook for Tecfidera?

Post-patent expiry, Tecfidera's revenue is projected to decline sharply, following historical patterns of patent cliffs in MS drugs. Biogen's overall revenue will be impacted but aims to offset this through growth in other indications and pipeline assets.

Projected revenue decline (2023–2025):

Year	Estimated Revenue (USD billion)	Change from previous year
2023	approx. 1.2	52% decline
2024	approx. 700 million	42% decline
2025	approx. 400 million	43% decline

The drop reflects generic competition, with the potential for stabilization if new indications or formulations succeed.

Key Takeaways

• Tecfidera is a major oral MS therapy with peak revenues exceeding $4 billion in 2018.
• Patent expiration in March 2023 has exposed Tecfidera to generic competition, significantly reducing its market share.
• Biogen’s revenue from Tecfidera is expected to decline sharply post-patent expiry, with projections indicating a 50%+ decline through 2023–2025.
• Competitive pressures from biosimilars and alternative MS treatments continue to erode Tecfidera’s market dominance.
• Future growth depends on pipeline development and expansion into new indications.

FAQs

Q1: When did Tecfidera lose its patent protection in the U.S.?
A1: March 2023.

Q2: How much revenue did Tecfidera generate in 2022?
A2: Approximately $2.49 billion.

Q3: What are the main competitors to Tecfidera?
A3: Dimethyl fumarate generics, Gilenya (fingolimod), Aubagio (teriflunomide), and other MS therapies.

Q4: What is the expected trend for Tecfidera’s revenue post-2023?
A4: Revenue is projected to decline sharply, with estimates showing a 50% or greater reduction over two years.

Q5: What factors could stabilize Tecfidera’s market share?
A5: Introduction of new indications, formulations, or combination therapies, alongside successful pipeline developments.

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References

[1] MarketResearch.com, "Multiple Sclerosis Therapeutics Market," 2023.

[2] Biogen Inc. Annual Report 2022.

[3] IQVIA, "MS Therapy Market Overview," 2022.

[4] EvaluatePharma, "MS Pharmaceutical Market Data," 2022.

DrugChatter Q&A for TECFIDERA

Tecfidera patent ep 973 november 2025?
Tecfidera clinical developpement?
Tecfidera generic entry 2020?
Biogen copay assistance tecfidera?
Tecfidera patentes espana?