MAVENCLAD Drug Patent Profile

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

Mavenclad is a drug marketed by Emd Serono Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-three patent family members in thirty-five countries.

The generic ingredient in MAVENCLAD is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mavenclad

A generic version of MAVENCLAD was approved as cladribine by HIKMA on February 28^th, 2000.

Summary for MAVENCLAD

International Patents:	153
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	12
Drug Prices:	Drug price information for MAVENCLAD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MAVENCLAD
What excipients (inactive ingredients) are in MAVENCLAD?	MAVENCLAD excipients list
DailyMed Link:	MAVENCLAD at DailyMed

See drug prices for MAVENCLAD

Recent Clinical Trials for MAVENCLAD

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

Sponsor	Phase
University of Leeds	Phase 2/Phase 3
The Leeds Teaching Hospitals NHS Trust	Phase 2/Phase 3
Queen Mary University of London	Phase 2/Phase 3

See all MAVENCLAD clinical trials

Pharmacology for MAVENCLAD

Drug Class

Purine Antimetabolite

Paragraph IV (Patent) Challenges for MAVENCLAD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAVENCLAD	Tablets	cladribine	10 mg	022561	1	2022-04-07

US Patents and Regulatory Information for MAVENCLAD

MAVENCLAD is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes			Y
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes			Y

Expired US Patents for MAVENCLAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019

EU/EMA Drug Approvals for MAVENCLAD

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Europe B.V.	Mavenclad	cladribine	EMEA/H/C/004230 Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.	Authorised	no	no	no	2017-08-22
Lipomed GmbH	Litak	cladribine	EMEA/H/C/000504 Litak is indicated for the treatment of hairy-cell leukaemia.	Authorised	no	no	no	2004-04-14

International Patents for MAVENCLAD

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

Country	Patent Number	Title	Estimated Expiration
Israel	274777	משטר קלאדריבין לטיפול בצורות מתקדמות של טרשת נפוצה (Cladribine regimen for treating progressive forms of multiple sclerosis)
Slovenia	2805723
Spain	2495392
Spain	2921858
Eurasian Patent Organization	200701221	РЕЖИМ ПРИМЕНЕНИЯ КЛАДРИБИНА ДЛЯ ЛЕЧЕНИЯ РАССЕЯННОГО СКЛЕРОЗА
Israel	212421	שימוש בקלאדריבין להכנת תכשיר לטיפול בטרשת נפוצה (Use of cladribine for preparation of a formulation for treating multiple sclerosis)
Montenegro	P34308	ORALNE FORMULACIJE KLADRIBINA (ORAL FORMULATIONS OF CLADRIBINE)

Supplementary Protection Certificates for MAVENCLAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1827461	18C1008	France		PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1608344	PA2018502,C1608344	Lithuania		PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1608344	LUC00065	Luxembourg		PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
2805723	PA2018503,C2805723	Lithuania		PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1827461	CR 2018 00010	Denmark		PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
2805723	PA2018503	Lithuania		PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
2805723	LUC00064	Luxembourg		PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824

MAVENCLAD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mavenclad

Introduction

Mavenclad, developed by Merck KGaA, has been a significant player in the highly competitive multiple sclerosis (MS) market since its approval. Here, we delve into the market dynamics and the financial trajectory of this drug, highlighting its performance, challenges, and future prospects.

Approval and Initial Market Impact

Mavenclad was approved by the FDA in March 2019 for the treatment of relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS)[4].

• This approval marked a crucial milestone, as Mavenclad became the only oral short-term therapy for these conditions, distinguishing it from other treatments in the market[1].

Sales Performance

Since its launch, Mavenclad has shown impressive sales growth:

• In 2019, Mavenclad generated €321 million ($358 million) in global sales, a more than 250% increase from the €90 million it posted in the previous year[1].
• By the end of 2019, Mavenclad's sales had already exceeded expectations, with the drug achieving around €300 million in sales, a figure that was anticipated for the full year[4].
• As of the fiscal year 2023, Mavenclad surpassed the $1 billion sales mark for the first time since its market launch, achieving blockbuster status[2][5].

Market Share and Competition

Mavenclad operates in a crowded MS market with several strong competitors:

• Despite the competition, Mavenclad has managed to secure a significant market share. By the end of 2019, it held more than a 5% share of the global MS market, up from 1% at the end of 2018[1].
• Key competitors include Roche's Ocrevus, Novartis’ Mayzent, and Biogen’s Tecfidera. However, Mavenclad's unique profile as an oral short-term therapy has helped it carve out a niche[4].

Payer Acceptance and Clinical Adoption

Mavenclad has seen positive payer acceptance and clinical adoption:

• In the USA, around 86% of neurologists were willing to prescribe Mavenclad, indicating strong clinical acceptance[3].
• In Europe, approximately 90% of Mavenclad patients returned for their second year of treatment, reflecting high patient retention rates[4].

Financial Impact on Merck KGaA

The success of Mavenclad has had a significant financial impact on Merck KGaA:

• Mavenclad's strong sales have offset the decline in sales of Merck's older MS medication, Rebif. In the third quarter of 2019, Mavenclad's sales growth covered the loss from Rebif's 15.1% year-over-year decline[4].
• The drug's performance has contributed to the overall growth of Merck KGaA's pharmaceutical business, which saw an 8% increase in sales at unchanged foreign exchange rates in 2019[4].

Regional Performance

Mavenclad's performance varies across different regions:

• In the USA, Mavenclad generated significant sales, with about a third of its third-quarter 2019 sales coming from the U.S. market[4].
• In Europe, where the drug was approved in August 2017, Mavenclad has seen broad adoption from both academic and community centers. For example, in Germany, its share of high-efficacy dynamic patients increased from 14% to 17% between Q1 and Q2 of 2019[3].

Future Prospects

Given its current trajectory, Mavenclad is poised for continued growth:

• Merck KGaA's ambition to keep core business sales organically stable includes significant contributions from Mavenclad. The company aims for Mavenclad to be a key driver of its €2 billion pipeline sales ambition by 2022[3].
• With its blockbuster status achieved, Mavenclad is expected to continue playing a vital role in Merck KGaA's financial performance and market presence in the MS treatment landscape.

Challenges and Opportunities

Despite its success, Mavenclad faces several challenges:

• The MS market is highly competitive, with new entrants and established players vying for market share. Continuous clinical and commercial efforts are necessary to maintain and expand Mavenclad's market position[4].
• Educational efforts and changing clinical habits, especially for diagnosing and treating SPMS, are crucial for further growth. This aligns with the broader industry trend of educating physicians about new therapies and their benefits[4].

"Mavenclad's strong performance has more than offset the sales loss from Merck KGaA's older MS med Rebif and represents a more than 5% share of the global MS market––up from 1% at the end of 2018"[1].

Key Takeaways

• Mavenclad has achieved significant sales growth since its FDA approval in 2019.
• The drug has secured a notable market share in the competitive MS market.
• Positive payer acceptance and high patient retention rates have contributed to its success.
• Mavenclad has offset the decline in sales of Merck KGaA's older MS medication, Rebif.
• The drug is expected to continue driving Merck KGaA's financial performance and market presence.

FAQs

Q: What is Mavenclad, and how is it different from other MS treatments? A: Mavenclad is an oral short-term therapy for relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). It is distinct from other treatments due to its oral administration and short treatment duration.

Q: How has Mavenclad performed in terms of sales since its launch? A: Mavenclad has shown exponential growth, increasing from €90 million in 2018 to €321 million in 2019 and surpassing $1 billion in sales by 2023.

Q: Who are the main competitors of Mavenclad in the MS market? A: Key competitors include Roche's Ocrevus, Novartis’ Mayzent, and Biogen’s Tecfidera.

Q: What has been the impact of Mavenclad on Merck KGaA's financial performance? A: Mavenclad's strong sales have offset the decline in sales of Merck's older MS medication, Rebif, and contributed to the overall growth of Merck KGaA's pharmaceutical business.

Q: What are the future prospects for Mavenclad in the MS market? A: Mavenclad is expected to continue driving Merck KGaA's financial performance and market presence, with the company aiming for significant contributions from the drug towards its €2 billion pipeline sales ambition.

Sources

1. FiercePharma - Merck KGaA's Mavenclad stakes its claim in massively competitive MS market
2. Merck KGaA - Financial results fiscal 2023
3. Merck KGaA - Kepler GCC Conference 2020 Presentation
4. FiercePharma - In crowded MS market, Merck KGaA's Mavenclad now offsets Rebif decline
5. Merck KGaA - Financial results fiscal 2023 | Merck KGaA, Darmstadt, Germany