VUMERITY Drug Patent Profile

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

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

This drug has fifty-eight patent family members in twenty-nine countries.

The generic ingredient in VUMERITY is diroximel fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the diroximel fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vumerity

A generic version of VUMERITY was approved as diroximel fumarate by ZYDUS on November 12^th, 2025.

Summary for VUMERITY

International Patents:	58
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	4
Patent Applications:	349
Drug Prices:	Drug price information for VUMERITY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VUMERITY
What excipients (inactive ingredients) are in VUMERITY?	VUMERITY excipients list
DailyMed Link:	VUMERITY at DailyMed

See drug prices for VUMERITY

Recent Clinical Trials for VUMERITY

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

Sponsor	Phase
University of Nebraska	EARLY_PHASE1
Biogen	Phase 1
Biogen	Phase 3

See all VUMERITY clinical trials

Paragraph IV (Patent) Challenges for VUMERITY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VUMERITY	Delayed-release Capsules	diroximel fumarate	231 mg	211855	1	2020-12-23

US Patents and Regulatory Information for VUMERITY

VUMERITY is protected by three 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	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019	AB	RX	Yes	Yes
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019	AB	RX	Yes	Yes			Y	Y
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019	AB	RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for VUMERITY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Biogen Netherlands B.V.	Vumerity	diroximel fumarate	EMEA/H/C/005437Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5.1 for important information on the populations for which efficacy has been established).	Authorised	no	no	no	2021-11-15

International Patents for VUMERITY

When does loss-of-exclusivity occur for VUMERITY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

New Zealand

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VUMERITY around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E040044
Japan	2016520524
Spain	2955137
Cyprus	1120529
Netherlands	301165
Spain	2955137

Supplementary Protection Certificates for VUMERITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970101	2290010-4	Sweden		PRODUCT NAME: DIROXIMELFUMARAT; NAT. REG. NO/DATE: EU/1/21/1585 20211116; FIRST REG.: CH 68066 20210920
2970101	2022C/507	Belgium		PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/21/1585 20211116
2970101	LUC00251	Luxembourg		PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: 68066; 20210920
2970101	PA2022003,C2970101	Lithuania		PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115
2970101	SPC/GB22/011	United Kingdom		PRODUCT NAME: DIROXIMEL FUMARATE; REGISTERED: CH CH 68066 20210920; UK PLGB 22407/0026-0001 20211108; UK SEE MA ON IPSUM 20211108
2970101	22C1011	France		PRODUCT NAME: DIROXIMEL FUMARATE; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211116; FIRST REGISTRATION: CH - 68066 20210920

Market Dynamics and Financial Trajectory for VUMERITY

Last updated: July 27, 2025

Introduction

VUMERITY (daclizumab high-yield process) is a prescription medication developed by Biogen, primarily indicated for the treatment of relapsing forms of multiple sclerosis (RMS). Approved by the U.S. Food and Drug Administration (FDA) in 2016, VUMERITY marked a significant advancement in immunomodulatory therapy. This article delineates the evolving market landscape for VUMERITY, including competitive positioning, regulatory influences, market opportunities, challenges, and its financial prospects within the broader pharmaceutical ecosystem.

Product Profile and Therapeutic Market

VUMERITY belongs to the class of monoclonal antibody therapies targeting the interleukin-2 receptor alpha (IL-2Rα). Its mechanism involves selective immunomodulation, reducing inflammatory lesions in RMS. The drug's approval followed the discontinuation of its predecessor, TYSABRI, due to safety concerns, positioning VUMERITY as a preferred oral or subcutaneous alternative.

The global multiple sclerosis therapeutics market is projected to reach USD 33 billion by 2028 from USD 24 billion in 2022, with a compounded annual growth rate (CAGR) of approximately 6.4% [1]. VUMERITY, positioned within this segment, benefits from increasing MS prevalence and demand for effective, well-tolerated disease-modifying therapies (DMTs).

Market Dynamics

Competitive Landscape

VUMERITY operates amid a competitive spectrum comprising injectable, oral, and infusion-based DMTs. Leading competitors include:

• Injectable therapies: Avonex, Betaseron, and Copaxone
• Oral therapies: Tecfidera (dimethyl fumarate), Aubagio (teriflunomide), and Mavenclad (cladribine)
• Infusion therapies: Tysabri (natalizumab) and Lemtrada (alemtuzumab)

The key differentiators for VUMERITY are its safety profile and convenience. Its immunomodulatory mechanism offers a potentially better tolerability profile compared to some competitors, though historical safety signals—particularly cases of autoimmune or immune-mediated adverse events—necessitate ongoing vigilance.

Regulatory and Safety Factors

VUMERITY's market dynamics are heavily influenced by regulatory scrutiny. In 2019, the European Medicines Agency (EMA) reviewed safety concerns regarding autoimmune conditions associated with the drug, impacting prescribing patterns [2]. Such safety considerations influence payer decisions, access, and physician preferences.

Additionally, post-marketing surveillance remains critical in shaping the drug’s profile, with ongoing studies evaluating long-term safety and efficacy.

Market Penetration and Adoption

Despite its efficacy, VUMERITY's adoption has faced hurdles including:

• Safety concerns: Limited long-term safety data compared to established drugs.
• Competitive inertia: Physicians' familiarity with existing treatments.
• Cost considerations: High drug pricing impacts formulary inclusion and patient access.

However, its convenience as a self-administered therapy drives steady adoption among patients seeking alternatives to injectable formulations.

Pricing and Reimbursement

VUMERITY’s pricing strategy aligns with premium MS treatments, with list prices exceeding USD 70,000 annually [3]. Payer negotiations, insurance coverage, and formularies significantly affect patient access and market share.

Reimbursement policies are nuanced, with some regions reserving VUMERITY for patients who experience adverse effects or insufficient response to other DMTs.

Financial Trajectory

Revenue Trends

Since its launch, VUMERITY has demonstrated moderate but consistent revenue growth within the broader MS market. At year-end 2022, Biogen reported VUMERITY-generated global revenues of approximately USD 150 million, marking a gradual upward trajectory [4]. Forecasts estimate annual revenues could surpass USD 500 million by 2026, contingent on market expansion and increased adoption.

Drivers of Revenue Growth

• Expansion into new markets: Regulatory approvals are underway in Japan and China, opening substantial markets.
• Physician and patient acceptance: Ongoing clinical data demonstrating safety and efficacy bolster confidence.
• Brand differentiation: Its oral/sc self-injectability option appeals to patients wary of infusion therapies.

Challenges to Revenue Growth

• Safety concerns and long-term data gaps: May temper confidence and slow adoption.
• Pricing pressures: Payer negotiations and biosimilar developments could threaten profit margins.
• Competitive erosion: Introduction of innovative oral therapies (e.g., ozanimod, ponesimod) by competitors can dilute market share.

Cost and Investment Considerations

Biogen continues to invest in clinical trials, patient education, and pharmacovigilance efforts. These costs influence short-term profitability but are essential for maintaining competitive edge and market credibility.

Regulatory and Market Outlook

The regulatory environment remains pivotal, with key agencies emphasizing safety. Biogen’s proactive engagement with regulators and healthcare providers is critical for sustaining VUMERITY’s authorized indications.

Market growth is anticipated to accelerate with expanded approvals, enhanced safety profiles, and the entrance of biosimilars or generic versions. Market analysts project a compound annual growth rate for VUMERITY revenues of approximately 12-15% over the next five years, driven by geographic expansion and improved market penetration [5].

Strategic Implications for Stakeholders

• Pharmaceutical companies: Investment in safety data, innovative delivery mechanisms, and market expansion is essential.
• Investors: Monitoring regulatory updates and patent landscapes can inform financial projections and risk assessments.
• Healthcare providers: Awareness of safety profiles and comparative efficacy aids informed prescribing.
• Payers: Engagement on pricing and value propositions will shape formulary decisions.

Key Challenges and Opportunities

• Safety profile management: Long-term data will influence market sustainability.
• Market expansion: Entry into emerging markets can drive revenue.
• Competitive innovation: Development of next-generation therapies may impact VUMERITY’s market share.
• Patient-centricity: Emphasizing administration convenience and safety enhances adoption.

Conclusion

VUMERITY’s market trajectory is characterized by moderate growth fueled by geographic expansion, competitive differentiation, and ongoing safety evaluations. Strategic management of safety concerns, pricing pressures, and regulatory landscapes will determine its long-term financial performance. Stakeholders who navigate these dynamics effectively can capitalize on the expanding MS therapeutics market, positioning VUMERITY as a valuable component in the evolving treatment paradigm.

Key Takeaways

• VUMERITY’s niche as an immunomodulatory therapy with a favorable administration profile supports steady growth, despite stiff competition.
• Regulatory scrutiny over safety signals necessitates persistent pharmacovigilance and transparent communication strategies.
• Geographic expansion into Asia and other emerging markets presents significant revenue opportunities.
• Pricing strategies and payer negotiations will be decisive in determining market access and adoption rates.
• Long-term safety data and comparative efficacy studies are critical in securing sustained market position.

FAQs

1. What distinguishes VUMERITY from other MS therapies?
   Its unique mechanism targeting IL-2Rα with a favorable safety profile and ease of self-administration enhances patient adherence and preference.

2. What are the key safety concerns associated with VUMERITY?
   Autoimmune reactions and immune-mediated adverse events have been observed, prompting ongoing safety evaluations.

3. How does VUMERITY compare economically to other MS treatments?
   It is priced at a premium (~USD 70,000+ annually), but its safety and convenience may justify costs for certain patient populations.

4. What is the outlook for VUMERITY’s global market penetration?
   With approvals in additional markets and clinical data supporting safety and efficacy, VUMERITY’s global footprint is expected to expand steadily.

5. How might biosimilars impact VUMERITY’s future?
   Biosimilar development could pressure pricing and market share; however, complex manufacturing processes may delay biosimilar entry.

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References

[1] MarketsandMarkets, “Multiple Sclerosis Therapeutics Market,” 2022.
[2] European Medicines Agency, “Assessment report for VUMERITY,” 2019.
[3] Biogen Annual Report, 2022.
[4] Biogen Q4 2022 Earnings Call Transcripts.
[5] GlobalData, "Multiple Sclerosis Drugs Market Forecast," 2023.