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 eighty-eight 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 MYLAN on August 17^th, 2020.

Summary for TECFIDERA

International Patents:	88
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	57
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
Assistance Publique - Hôpitaux de Paris	Phase 2
Banner Life Sciences LLC	Phase 1
Fondation Ophtalmologique Adolphe de Rothschild	Phase 4

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
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

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	204063-002	Mar 27, 2013
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	204063-002	Mar 27, 2013
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	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/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
Laboratorios Lesvi S.L.	Dimethyl fumarate Neuraxpharm	dimethyl fumarate	EMEA/H/C/006039 Dimethyl 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/005963 Dimethyl 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

International Patents for TECFIDERA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2424022
European Patent Office	3116536	FUMARATE DE DIMÉTHYLE ET RÉGIMES DE VACCINATION (DIMETHYL FUMARATE AND VACCINATION REGIMENS)
Austria	242633
Brazil	9914606
Hong Kong	1139204	COMPOSITIONS AND USES FOR TREATING MULTIPLE SCLEROSIS
China	113368092	治疗多发性硬化的方法 (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
0230742	2001C/040	Belgium		PRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113
2137537	122014000069	Germany		PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2653873	LUC00294	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE (TECFIDERA); AUTHORISATION NUMBER AND DATE: EU/1/13/837/001-002 20140203
0526708	SPC/GB02/030	United Kingdom		PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
2653873	2023C/501	Belgium		PRODUCT NAME: FUMARATE DE DIMETHYLE; AUTHORISATION NUMBER AND DATE: EU/1/13/837 20140203

TECFIDERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Tecfidera

Introduction

Tecfidera, also known as dimethyl fumarate, is a pivotal drug in the treatment of multiple sclerosis (MS), particularly for patients with relapsing forms of the disease. Developed and marketed by Biogen, Tecfidera has had a significant impact on the MS treatment landscape since its launch. Here, we delve into the market dynamics and financial trajectory of Tecfidera.

Launch and Initial Market Impact

Tecfidera was launched in 2013 and quickly gained traction due to its perceived greater efficacy compared to other oral therapies available at the time, such as Aubagio[1].

• The drug's launch was highly anticipated by physicians, leading to a rapid uptake and a steep growth trajectory. This surge in adoption was partly due to physicians "warehousing" patients in anticipation of the drug's availability.

Market Growth and Dominance

In the early years following its launch, Tecfidera exhibited strong growth, particularly in the EU5 markets (Germany, UK, Italy, Spain, and France) and the US. The drug's growth mirrored the decline in injectable MS therapies, indicating a shift in treatment preferences towards oral medications[1].

• By 2015, Tecfidera had established itself as a leading oral therapy for MS, with its growth trajectory sustained by continued confidence from physicians in various markets.

Economic Value and Social Impact

Tecfidera, along with other MS therapies like Avonex and Tysabri, has generated significant economic and social value. A study indicated that these therapies provided $46.2 billion in total value to consumers, with a substantial portion of this value accruing to individuals without MS due to the "peace of mind" factor[3].

• The use of Tecfidera has been associated with reduced relapse rates and disability progression, although the exact income and medical cost effects were conservatively estimated based on Avonex data due to limited sample sizes[3].

Competitive Landscape

The MS treatment market is highly competitive, with several immunomodulators, immunosuppressants, and interferons available. Tecfidera has been a key player in the immunomodulators segment, which dominates the U.S. MS drugs market[4].

• Biogen, the manufacturer of Tecfidera, has maintained a significant market share due to the strong sales of its MS products, including Tecfidera and Vumerity[4].

Financial Performance

Tecfidera has been a major revenue generator for Biogen. However, in recent years, the drug has faced significant challenges:

• Generic Competition: The entry of generic versions of Tecfidera has led to a decline in its revenue. In the fourth quarter of 2023, Tecfidera's revenue dropped by 17.8% to $244.3 million due to generic competition[5].
• Market Share and Revenue: Despite its initial success, Tecfidera's market share and revenue have been impacted by the launch of generics and other competitive therapies. Biogen's overall MS revenue declined by 8% in the fourth quarter of 2023[5].

Future Outlook

Biogen is navigating the challenges posed by generic competition and patent expirations by focusing on new product launches and diversifying its portfolio:

• New Product Launches: Biogen is banking on new approvals, such as Skyclarys for Friedreich’s ataxia and Leqembi for Alzheimer’s disease, to offset the decline in MS drug sales. These new products are expected to play a significant role in the company's revenue growth strategy over the next decade[5].
• Market Projections: The U.S. MS drugs market, which includes Tecfidera, is projected to grow from $9.45 billion in 2023 to $14.10 billion by 2030, with a CAGR of 5.9%. However, the immunomodulators segment, where Tecfidera resides, will face continued competition and potential erosion from generics[4].

Challenges and Opportunities

Generic Entry

The entry of generic versions of Tecfidera poses a significant challenge to its revenue. Biogen expects further declines in Tecfidera revenue due to generic competition in both the U.S. and EU markets[2].

Regulatory and Market Dynamics

The ongoing challenges to Tecfidera's market protection and the potential entry of generics in the EU as early as the first half of 2022 add uncertainty to its financial trajectory[2].

Diversification and New Launches

Biogen's strategy to reposition itself away from its legacy MS franchise towards new products offers opportunities for growth. The success of new launches will be crucial in mitigating the impact of declining MS drug sales[5].

Key Takeaways

• Rapid Uptake: Tecfidera quickly gained market share upon its launch due to its perceived efficacy.
• Economic Value: The drug has generated significant economic and social value, including reduced relapse rates and disability progression.
• Generic Competition: The entry of generics has significantly impacted Tecfidera's revenue.
• Future Outlook: Biogen is diversifying its portfolio to offset declines in MS drug sales, focusing on new product launches.

FAQs

What was the initial market impact of Tecfidera upon its launch?

Tecfidera stormed the market upon its launch in 2013, driven by high anticipation and perceived greater efficacy compared to other oral therapies available at the time.

How has generic competition affected Tecfidera's revenue?

Generic competition has led to a significant decline in Tecfidera's revenue, with a 17.8% drop in the fourth quarter of 2023.

What is the projected growth of the U.S. MS drugs market?

The U.S. MS drugs market is projected to grow from $9.45 billion in 2023 to $14.10 billion by 2030, with a CAGR of 5.9%.

How is Biogen addressing the decline in MS drug sales?

Biogen is focusing on new product launches and diversifying its portfolio to offset the decline in MS drug sales, with a strategy to reposition itself away from its legacy MS franchise.

What are the key challenges facing Tecfidera in the current market?

The key challenges include generic competition, regulatory uncertainties, and the ongoing erosion of market protection.

Sources

1. Ipsos Healthcare: Multiple Sclerosis: The Evolving Competitive Landscape, the Future Challenges and the Opportunities.
2. Biogen Investors: Biogen Reports Fourth Quarter and Full Year 2021 Results.
3. American Journal of Managed Care: Reconsidering the Economic Value of Multiple Sclerosis Therapies.
4. Fortune Business Insights: U.S. Multiple Sclerosis Drugs Market Research Report [2030].
5. BioSpace: Biogen Misses Q4 Revenue Estimates on Aduhelm Costs, Lower MS Drug Sales.