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, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in seventeen 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 eighty-eight patent family members in twenty-nine countries.

There are twenty-eight drug master file entries for dimethyl fumarate. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dimethyl fumarate

International Patents:	88
US Patents:	9
Tradenames:	2
Applicants:	17
NDAs:	17
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	20
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
Lupin	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210226-001	Oct 5, 2020	AB	RX	No	No
Hetero Labs Ltd Iii	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210500-002	Sep 24, 2020	AB	RX	No	No
Alkem Labs Ltd	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210440-002	Sep 24, 2020	AB	RX	No	No
Mylan	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210531-001	Aug 17, 2020	AB	RX	No	No
Hetero Labs Ltd Iii	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210500-001	Sep 24, 2020	AB	RX	No	No
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes	8,399,514

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	8,524,773
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	6,509,376
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	204063-002	Mar 27, 2013	7,619,001
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	8,759,393

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
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 dimethyl fumarate

Country	Patent Number	Title	Estimated Expiration
Cyprus	2014026
Lithuania	2653873
European Patent Office	2680007	Essais de criblage de Nrf2 et procédés et compositions correspondants (Nrf2 screening assays and related methods and compositions)
Norway	2023001
European Patent Office	2680009	Essais de criblage de Nrf2 et procédés et compositions correspondants (Nrf2 screening assays and related methods and compositions)
Australia	2022221548	DIMETHYL FUMARATE AND VACCINATION REGIMENS

Supplementary Protection Certificates for dimethyl fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1131065	CA 2014 00036	Denmark		PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
2137537	SPC/GB14/046	United Kingdom		PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203
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	300674	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130

Dimethyl fumarate Market Analysis and Financial Projection Experimental

Dimethyl Fumarate: Market Dynamics and Financial Trajectory

Introduction to Dimethyl Fumarate

Dimethyl fumarate (DMF) is a crucial drug in the treatment of relapsing-remitting multiple sclerosis (RRMS), a debilitating neurological condition. Here, we delve into the market dynamics and financial trajectory of DMF, highlighting its growth, drivers, and financial implications.

Market Growth and Projections

The dimethyl fumarate API market has experienced significant growth in recent years and is projected to continue this upward trend from 2023 to 2031. This growth is driven by several factors, including the increasing prevalence of multiple sclerosis, the efficacy of DMF in treating RRMS, and the expanding market share of oral therapies over traditional injectables[1][3][4].

Market Size and Revenue

The global dimethyl fumarate market is anticipated to grow substantially, with the API market segment expected to see robust growth rates. The market size in 2023 was notable, and projections indicate a compound annual growth rate (CAGR) that will drive the market to new heights by 2031[1][4].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region contributes significantly to the overall market growth, with varying levels of penetration and adoption rates. The regional analysis provides insights into the revenue share, current trends, and future prospects for DMF in these areas[4].

Drivers of Market Growth

Increasing Prevalence of Multiple Sclerosis

Multiple sclerosis is one of the most widespread disabling neurological conditions among young adults globally. The rising prevalence of MS, particularly RRMS, drives the demand for effective treatments like DMF[3].

Efficacy and Convenience

DMF is an orally administered disease-modifying treatment, offering improved convenience over injectable therapies. Its efficacy in reducing relapse rates and improving patient outcomes is a significant driver of its market growth[2].

Pipeline Products and New Entrants

The launch of new pipeline products targeting progressive MS subtypes (primary-progressive MS and secondary progressive MS) and the entry of new players in the market further boost the growth of the DMF market[3].

Financial Trajectory

Acquisition Costs and Cost Savings

The introduction of DMF in healthcare systems, such as in Canada, results in increased drug acquisition costs. However, these costs are partially offset by reductions in costs associated with relapses. For instance, in Canada, the average annual increase in costs per treated patient was CAD417, with a reduction of CAD192 in relapse-related costs[2].

Budget Impact Analysis

A budget impact model (BIM) analysis revealed that the introduction of DMF leads to an average annual cost increase, but this is mitigated by the reduced costs of managing relapses. On a population level, the average annual cost increase was CAD24,654,237, which translates to a CAD 0.68 increase per population covered by the healthcare system[2].

Financial Assistance Programs

To make DMF more accessible, pharmaceutical companies like Biogen offer financial and insurance assistance programs. For example, the Biogen Copay Program can lower the medication cost to as little as $0 for most commercially insured patients, highlighting the efforts to manage the financial burden on patients[5].

Market Segmentation and Analysis

Type and Application

The dimethyl fumarate market is segmented based on type (e.g., Dimethyl Fumarate 97%, Dimethyl Fumarate 98%) and application (pharmaceutical, food, drink, feed, cosmetic, etc.). This segmentation helps in understanding the key industry segments and their growth prospects[4].

Competitive Landscape

The market is competitive, with key players such as Abcam, Cayman Chemical, and BioVision Inc. focusing on strategy building and product portfolio expansion. The competitive analysis includes market share, product offerings, and strategic initiatives of these companies[4].

Challenges and Opportunities

Regulatory and Economic Factors

The market is influenced by regulatory, economic, and social landscapes of different countries. Factors such as profit margins, product pricing, and supply-demand dynamics play crucial roles in shaping the market[1][4].

Technological Trends

Advancements in technology and the development of new formulations and delivery systems present opportunities for growth. However, they also pose challenges in terms of regulatory approvals and market acceptance[4].

Key Takeaways

• Robust Market Growth: The dimethyl fumarate API market is expected to grow significantly from 2023 to 2031.
• Efficacy and Convenience: DMF's oral administration and efficacy in treating RRMS drive its market demand.
• Financial Balance: Increased acquisition costs are partially offset by reduced relapse-related costs.
• Regional Variations: Market growth varies across regions, with North America, Europe, and Asia-Pacific being key contributors.
• Competitive Landscape: The market is competitive, with major players focusing on product portfolio expansion and financial assistance programs.

FAQs

What is the projected market size of the dimethyl fumarate API market by 2031?

The dimethyl fumarate API market is projected to undergo significant growth, with detailed revenue projections indicating robust expansion by 2031[1].

How does dimethyl fumarate impact the costs associated with treating RRMS?

The introduction of DMF increases drug acquisition costs but reduces costs associated with relapses, leading to a partial offset of the increased costs[2].

What are the key drivers of the dimethyl fumarate market growth?

Key drivers include the increasing prevalence of MS, the efficacy and convenience of DMF, and the launch of new pipeline products targeting progressive MS subtypes[3].

Which regions are major contributors to the dimethyl fumarate market?

North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America are the major regions contributing to the market growth[4].

What financial assistance programs are available for patients taking dimethyl fumarate?

Biogen offers financial and insurance assistance programs, such as the Biogen Copay Program, to help manage the medication costs for commercially insured patients[5].

Sources

1. MarketResearchIntellect: Global Dimethyl Fumarate API Market Size, Trends and Projections.
2. PubMed: The budget impact of introducing delayed-release dimethyl fumarate.
3. iHealthcareAnalyst: Global Multiple Sclerosis Drugs Market $35.7 Billion by 2031.
4. Cognitive Market Research: Dimethyl Fumarate Market Report 2024 (Global Edition).
5. Biogen: Financial and Insurance Assistance | VUMERITY® (diroximel fumarate).