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KOSELUGO Drug Patent Profile

Which patents cover Koselugo, and what generic alternatives are available?

Koselugo is a drug marketed by Astrazeneca and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and ninety-eight patent family members in forty-four countries.

The generic ingredient in KOSELUGO is selumetinib sulfate. One supplier is listed for this compound. Additional details are available on the selumetinib sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Koselugo

Koselugo was eligible for patent challenges on April 10, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 10, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KOSELUGO

International Patents:	198
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	12
Patent Applications:	1,987
Drug Prices:	Drug price information for KOSELUGO
What excipients (inactive ingredients) are in KOSELUGO?	KOSELUGO excipients list
DailyMed Link:	KOSELUGO at DailyMed

See drug prices for KOSELUGO

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

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)

NDA:

213756

Dosage:

CAPSULE;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 KOSELUGO

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

Sponsor	Phase
Children's Hospital of Philadelphia	Phase 2
University of Alabama at Birmingham	Phase 2
Congressionally Directed Medical Research Programs	Phase 2

See all KOSELUGO clinical trials

Pharmacology for KOSELUGO

Drug Class	Kinase Inhibitor
Mechanism of Action	Mitogen-Activated Protein Kinase Kinase 1 Inhibitors Mitogen-Activated Protein Kinase Kinase 2 Inhibitors

US Patents and Regulatory Information for KOSELUGO

KOSELUGO is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN).

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
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No	9,562,017			Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No	9,156,795		Y	Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes	7,425,637			Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes	9,562,017			Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No	11,813,246		Y

International Patents for KOSELUGO

When does loss-of-exclusivity occur for KOSELUGO?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

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 KOSELUGO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2130536	Dérivés de benzimidazole d'alkylat N3 en tant qu'inhibiteurs de Mek (N3 alkylated benzimidazole derivatives as mek inhibitors)
Serbia	52409	FARMACEUTSKA SMEŠA 271 (PHARMACEUTICAL COMPOSITION 271)
Brazil	0306026	Derivados de benzimidazol alquilado por n3 como inibidores de mek
World Intellectual Property Organization (WIPO)	2005023251
Iceland	8384	Alkýleraðar bensímídasólafleiður sem MEK-hindrar
World Intellectual Property Organization (WIPO)	2009118562
China	101486682	N3 alkylated benzimidazole derivatives as MEK inhibitors

Supplementary Protection Certificates for KOSELUGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	C20190010 00281	Estonia		PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
1968948	PA2021530,C1968948	Lithuania		PRODUCT NAME: SELUMETINIBAS; REGISTRATION NO/DATE: EU/1/21/1552 20210617
1482932	C 2019 008	Romania		PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
1482932	LUC00100	Luxembourg		PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
1482932	SPC/GB19/007	United Kingdom		PRODUCT NAME: BINIMETINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1315/001-002 20180920
1482932	122019000022	Germany		PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1482932	300974	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME

KOSELUGO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KOSELUGO (Selumetinib)

Introduction to KOSELUGO

KOSELUGO (selumetinib) is a groundbreaking kinase inhibitor that has revolutionized the treatment of plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1). Here, we delve into the market dynamics and financial trajectory of this significant therapeutic advancement.

Regulatory Approvals and Designations

KOSELUGO has garnered several key regulatory approvals and designations that have significantly impacted its market presence. It was approved by the US FDA in April 2020 for the treatment of pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable plexiform neurofibromas[4].

• Global Approvals: KOSELUGO has been approved in the U.S., European Union, Japan, and China. In Japan, it was approved in September 2022 for pediatric patients three years of age and older with symptomatic PN[3].
• Designations: It has been granted Orphan Drug Designation in the U.S., EU, Japan, and other countries, as well as Rare Pediatric Disease Designation and Breakthrough Therapy Designation by the FDA[4].

Clinical Trials and Efficacy

The efficacy of KOSELUGO has been demonstrated through several clinical trials, most notably the SPRINT Phase II trial and the recent Phase 3 KOMET trial.

• SPRINT Trial: This trial showed that KOSELUGO reduced tumor volume in children, alleviating symptoms such as pain and disfigurement[3][4].
• KOMET Trial: The Phase 3 KOMET trial, the largest global randomized double-blind placebo-controlled multicenter trial in adults with NF1, demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) versus placebo. This trial has the potential to expand KOSELUGO's use to adult patients[1].

Market Impact

The approvals and positive trial results have significantly influenced the market dynamics for KOSELUGO.

• Market Size: The global plexiform neurofibromas treatment market, driven in part by KOSELUGO, was valued at USD 1,371.14 million in 2022 and is expected to reach USD 2,576.19 million by 2030[3].
• Adoption: The increasing adoption of KOSELUGO, especially with its expansion into adult treatment, is expected to drive market growth. Regulatory approvals in various regions have been a key factor in this growth[3].

Financial Performance

The financial trajectory of KOSELUGO is closely tied to its regulatory approvals, clinical trial outcomes, and market adoption.

• Revenue Contribution: KOSELUGO's revenue is included in the Rare Disease segment of AstraZeneca's financial reports. In FY 2022, the Rare Disease segment saw a 10% increase in revenue, partly due to KOSELUGO's performance[5].
• Collaboration Revenue: AstraZeneca and Merck's collaboration on KOSELUGO involves AstraZeneca booking all monotherapy product sales, with half of the gross profits due to Merck. This collaboration has contributed to the financial success of both companies[4].

Strategic Collaborations

The strategic collaboration between AstraZeneca and Merck has been instrumental in the development and commercialization of KOSELUGO.

• Global Collaboration: Announced in July 2017, this collaboration involves co-developing and co-commercializing KOSELUGO, as well as other potential new medicines. This partnership has enhanced the global reach and development capabilities of KOSELUGO[4].
• Pipeline Development: The collaboration extends to developing KOSELUGO in combination with other medicines, including PD-L1 and PD-1 inhibitors, further expanding its therapeutic potential[4].

Financial Projections and Growth

The financial projections for KOSELUGO are optimistic, driven by its expanding indications and growing market demand.

• Revenue Growth: With the potential expansion into adult treatment and continued strong performance in pediatric patients, KOSELUGO is expected to contribute significantly to the revenue growth of both AstraZeneca and Merck.
• Market Expansion: The approval in various regions and the positive outcomes from the KOMET trial are expected to drive further market expansion and revenue increase[1][3].

Challenges and Restraints

While KOSELUGO has shown significant promise, there are challenges and restraints to its market dynamics.

• Safety Considerations: KOSELUGO's safety profile includes potential cardiac effects, such as a decrease in left ventricular ejection fraction (LVEF), which requires careful monitoring and management[1].
• Competition: The plexiform neurofibromas treatment market, although growing, faces competition from other emerging therapies and treatments, which could impact KOSELUGO's market share[3].

Key Takeaways

• Regulatory Approvals: KOSELUGO has received critical regulatory approvals in multiple regions.
• Clinical Efficacy: Positive trial results, including the Phase 3 KOMET trial, have demonstrated its efficacy in both pediatric and adult patients.
• Market Growth: The global plexiform neurofibromas treatment market is expected to grow significantly, driven by KOSELUGO's adoption.
• Financial Performance: KOSELUGO contributes to the revenue growth of AstraZeneca and Merck through their strategic collaboration.
• Challenges: Safety considerations and market competition are key restraints to its market dynamics.

FAQs

What is KOSELUGO used for?

KOSELUGO (selumetinib) is used for the treatment of symptomatic, inoperable plexiform neurofibromas in patients with Neurofibromatosis Type 1 (NF1), initially approved for pediatric patients and now showing potential for adult patients[1][4].

What are the key regulatory approvals for KOSELUGO?

KOSELUGO has been approved by the US FDA, European Union, Japan, and China. It has also received Orphan Drug Designation, Rare Pediatric Disease Designation, and Breakthrough Therapy Designation[1][3][4].

What are the results of the Phase 3 KOMET trial?

The Phase 3 KOMET trial demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) versus placebo in adults with NF1 who have symptomatic, inoperable plexiform neurofibromas[1].

How does KOSELUGO work?

KOSELUGO is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cell growth. By blocking these enzymes, KOSELUGO slows down the growth of tumor cells, reducing the growth of plexiform neurofibromas[1][4].

What are the financial implications of KOSELUGO for AstraZeneca and Merck?

KOSELUGO contributes to the revenue growth of both AstraZeneca and Merck through their strategic collaboration. AstraZeneca books all monotherapy product sales, with half of the gross profits due to Merck[4].

What are the potential challenges for KOSELUGO in the market?

KOSELUGO faces challenges such as safety considerations, including potential cardiac effects, and competition from other emerging therapies in the plexiform neurofibromas treatment market[1][3].

Sources

1. Merck News: KOSELUGO® (selumetinib) Showed Significant and Clinically Meaningful Improvement in Objective Response Rate Versus Placebo in Adults With Neurofibromatosis Type 1 who Have Symptomatic, Inoperable Plexiform Neurofibromas in Global Phase 3 KOMET Trial.
2. BioSpace: AstraZeneca's 9M and Q3 2024 results.
3. Coherent Market Insights: Plexiform Neurofibromas Treatment Market Size By 2030.
4. AstraZeneca Media Centre: Koselugo (selumetinib) approved in US for paediatric patients with neurofibromatosis type 1 plexiform neurofibromas.
5. AstraZeneca Full Year and Q4 2022 Results Announcement.