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-three patent family members in twenty-six 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^® Generic Entry Outlook for Vumerity

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 20, 2033. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VUMERITY

International Patents:	53
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	3
Patent Applications:	87
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VUMERITY

NDA:

211855

Dosage:

CAPSULE, DELAYED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VUMERITY

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

Sponsor	Phase
Biogen	Phase 1
Biogen	Phase 3
Banner Life Sciences LLC	Phase 1

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.

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

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		RX	Yes	Yes
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019		RX	Yes	Yes			Y	Y
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019		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/005437 Vumerity 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

Mexico

New Zealand

Poland

Portugal

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
Brazil	112015022854	pró-farmacos de fumaratos e uso do mesmo no tratamento de várias doenças
Canada	2906580	PROMEDICAMENTS DE FUMARATES ET LEUR UTILISATION POUR LE TRAITEMENT DE DIVERSES MALADIES (PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DESEASES)
Israel	260511
Japan	2016520524	フマル酸エステルのプロドラッグおよび種々の疾患の治療におけるその使用
Lithuania	PA2022003
New Zealand	631337	Prodrugs of fumarates and their use in treating various diseases

Supplementary Protection Certificates for VUMERITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970101	122022000014	Germany		PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211115; FIRST REGISTRATION: SCHWEIZ 68066 20210920
2970101	2022C/507	Belgium		PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/21/1585 20211116
2970101	2290010-4	Sweden		PRODUCT NAME: DIROXIMELFUMARAT; NAT. REG. NO/DATE: EU/1/21/1585 20211116; FIRST REG.: CH 68066 20210920
2970101	C202230010	Spain		PRODUCT NAME: FUMARATO DE DIROXIMEL; NATIONAL AUTHORISATION NUMBER: EU/1/21/1585; DATE OF AUTHORISATION: 20211115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 68066; DATE OF FIRST AUTHORISATION IN EEA: 20210920
2970101	PA2022003	Lithuania		PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115
2970101	PA2022003,C2970101	Lithuania		PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115

Market Dynamics and Financial Trajectory for VUMERITY

Introduction to VUMERITY

VUMERITY (diroximel fumarate) is an oral delayed-release capsule approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Developed by Biogen and Alkermes, VUMERITY has been positioned as a next-generation treatment in the MS market[4][5].

Market Context: U.S. Multiple Sclerosis Drugs Market

The U.S. multiple sclerosis drugs market is projected to grow significantly, with an estimated value of USD 9.45 billion in 2023 and expected to reach USD 14.10 billion by 2030, exhibiting a CAGR of 5.9% during the forecast period. This growth is driven by factors such as the increasing number of pipeline drugs and new product launches, particularly in the immunomodulators segment, where VUMERITY is categorized[1].

Drug Class and Segment Dominance

VUMERITY falls under the immunomodulators segment, which dominated the U.S. multiple sclerosis drugs market in 2022. This segment's growth is fueled by strong sales of drugs like Mavenclad and Tecfidera, as well as the increasing focus on developing immunomodulator drugs for MS treatment. The immunosuppressants segment, however, is expected to grow at the fastest CAGR due to the efficacy of these drugs in clinical trials[1].

Efficacy and Clinical Trials

Clinical trials have shown that VUMERITY, which takes the same active form as dimethyl fumarate (DMF), is effective in reducing relapses and delaying the progression of disability in patients with relapsing-remitting MS. Over 70% of patients taking DMF were relapse-free after two years, and the drug reduced the number of relapses by 53% compared to placebo. Additionally, DMF delayed disability progression, with 84% of patients showing no progression compared to 73% on placebo[3].

Pricing and Affordability

VUMERITY was launched with a wholesale acquisition cost (WAC) of $88,000 per year, which has been a point of contention. While Biogen argued that this is the lowest annual WAC price for oral MS disease-modifying therapies, critics, including the National MS Society, have highlighted that this price is still unaffordable for many patients. This pricing is particularly significant when compared to Biogen’s older oral MS drug, Tecfidera, which entered the market at $54,750 per year but has since increased to $94,991[4].

Financial Performance and Revenue

Alkermes, the partner in the development and commercialization of VUMERITY, reported significant financial gains. In the third quarter of 2023, manufacturing and royalty revenues from VUMERITY were $34.6 million, up from $26.3 million in the same period the previous year. This increase is part of Alkermes' overall strong financial performance, with total revenues for the quarter reaching $380.9 million, a 51% increase from the previous year[2].

Market Competition and Patient Transition

Despite its efficacy, VUMERITY faces challenges in the market, particularly in convincing patients who are stable on Tecfidera to switch to the new drug. This hesitation is reflected in consensus estimates, which forecast modest sales of VUMERITY at $111 million in 2024. The patent pressures on Tecfidera, however, make VUMERITY a strategic move for Biogen to maintain market share[4].

Distribution and Access

The distribution of VUMERITY, like other MS drugs, is influenced by the growing trend of online pharmacies, which are expected to grow at the fastest CAGR. Online portals offering discounts on medication delivery can impact the sales and accessibility of VUMERITY[1].

Financial Assistance and Cost Management

To make VUMERITY more accessible, various financial assistance programs are available. Patients can explore options such as getting a 90-day supply of the drug, which could help lower the cost if approved by their insurance company. Additionally, savings programs and other payment assistance initiatives can help manage the high cost of the medication[5].

Key Players and Market Share

Biogen, along with its partner Alkermes, holds a significant market share in the U.S. multiple sclerosis drugs market. Biogen's strong sales of products like Tecfidera, Vumerity, and others have contributed to its dominance. The company's focus on getting approvals for commercialization of MS drugs further fuels its market position[1].

Future Outlook

The future outlook for VUMERITY is tied to the broader trends in the MS drugs market. As the market continues to grow, driven by new product launches and increasing demand for effective treatments, VUMERITY is positioned to capture a significant share. However, addressing affordability concerns and convincing patients to switch from established treatments will be crucial for its long-term success.

Key Takeaways

• Market Growth: The U.S. multiple sclerosis drugs market is projected to grow at a CAGR of 5.9% from 2023 to 2030.
• Efficacy: VUMERITY has shown significant efficacy in reducing relapses and delaying disability progression in clinical trials.
• Pricing: The drug's high price of $88,000 per year has been a point of contention, despite being the lowest WAC for oral MS therapies.
• Financial Performance: Alkermes reported increased revenues from VUMERITY, contributing to its overall strong financial performance.
• Market Competition: VUMERITY faces competition from established drugs like Tecfidera, making patient transition a challenge.
• Financial Assistance: Various programs are available to help manage the high cost of VUMERITY.

FAQs

1. What is VUMERITY used for?

VUMERITY (diroximel fumarate) is used for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.

2. How effective is VUMERITY in clinical trials?

Clinical trials have shown that VUMERITY reduces relapses by 53% compared to placebo and delays disability progression, with 84% of patients showing no progression over two years[3].

3. Why is VUMERITY priced so high?

VUMERITY is priced at $88,000 per year, which is the lowest annual WAC price for oral MS disease-modifying therapies, but still higher than what many patients can afford[4].

4. How does VUMERITY compare to other MS treatments like Tecfidera?

VUMERITY is priced slightly lower than Tecfidera but faces challenges in convincing patients to switch from the established drug. The cost comparison depends on factors like treatment length and insurance coverage[5].

5. Are there any financial assistance programs available for VUMERITY?

Yes, various financial assistance programs, including savings programs and options for a 90-day supply, are available to help manage the cost of VUMERITY[5].

Cited Sources:

1. Fortune Business Insights - U.S. Multiple Sclerosis Drugs Market Research Report [2030]
2. PR Newswire - Alkermes plc Reports Third Quarter 2023 Financial Results
3. Vumerity.com - Effectiveness | VUMERITY® (diroximel fumarate)
4. PMLiVE - Biogen under fire over $88,000 Vumerity annual price
5. MedicalNewsToday - Vumerity cost 2024: Coupons and more