SELUMETINIB SULFATE - Generic Drug Details

What are the generic drug sources for selumetinib sulfate and what is the scope of freedom to operate?

Selumetinib sulfate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selumetinib sulfate has one hundred and ninety-eight patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for SELUMETINIB SULFATE

International Patents:	198
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	37
Patent Applications:	42
DailyMed Link:	SELUMETINIB SULFATE at DailyMed

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

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)

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 SELUMETINIB SULFATE

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 3
United States Department of Defense	Phase 2
Sarcoma Alliance for Research through Collaboration	Phase 2

See all SELUMETINIB SULFATE clinical trials

Pharmacology for SELUMETINIB SULFATE

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

Anatomical Therapeutic Chemical (ATC) Classes for SELUMETINIB SULFATE

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for SELUMETINIB SULFATE

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	213756-002	Apr 10, 2020		RX	Yes	Yes
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No			Y	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			Y	Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No				Y

International Patents for SELUMETINIB SULFATE

Country	Patent Number	Title	Estimated Expiration
Iceland	2999
Singapore	148857	N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS
Denmark	2271321
Japan	5498546
Cyprus	1114303

Supplementary Protection Certificates for SELUMETINIB SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122019000022	Germany		PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1482932	2019C/510	Belgium		PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
1968948	LUC00234	Luxembourg		PRODUCT NAME: SELUMETINIB (INCLUANT TOUS SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER LE SULFATE D'HYDROGENE), SES ESTERS, SOLVATES ET ENANTIOMERES); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619
1482932	PA2019007,C1482932	Lithuania		PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920

SELUMETINIB SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Selumetinib Sulfate (Koselugo)

Introduction

Selumetinib sulfate, marketed as Koselugo, is a selective MEK1/2 inhibitor approved for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Regulatory Landscape

Selumetinib was approved by the FDA on April 10, 2020, and later by Health Canada on August 23, 2022. This approval was facilitated through collaborative efforts under Project Orbis, involving regulatory bodies from the US, Canada, Singapore, Switzerland, and Australia[1][2][4].

Therapeutic Indications and Market Need

NF1 is a rare genetic disorder affecting approximately 1 in 3,000 individuals, often leading to the development of plexiform neurofibromas. Selumetinib's approval addresses a significant unmet need for these patients, offering a targeted therapy that can shrink associated tumors and improve clinical outcomes[2].

Pharmacoeconomic Analysis

The cost-effectiveness of selumetinib has been a subject of extensive analysis. Studies by CADTH (Canadian Agency for Drugs and Technologies in Health) indicate that selumetinib is not cost-effective at a willingness-to-pay threshold of $50,000 per quality-adjusted life-year (QALY) gained. The incremental cost-effectiveness ratio (ICER) for selumetinib plus best supportive care (BSC) compared to BSC alone was found to be significantly high, ranging from $294,751 to $426,286 per QALY gained[3].

Pricing and Cost Implications

The drug is available in 10 mg and 25 mg oral capsules, priced at $122.60 and $306.50 per capsule, respectively. For a hypothetical patient with a body surface area of 1.12 m², the annual cost of selumetinib at the recommended dosage of 25 mg/m² twice daily is estimated to be approximately $268,677, plus additional costs for BSC, totaling $268,913 per year[3].

Market Access and Reimbursement

Given the high cost of selumetinib, market access and reimbursement are critical factors. The sponsor's economic evaluation submitted to health authorities highlights the need for significant price reductions (88.5% or 83.2%) to make the drug cost-effective at standard thresholds. This poses a challenge for widespread adoption and reimbursement by public healthcare systems[3].

Adverse Reactions and Safety Profile

While selumetinib has shown efficacy, it is associated with several adverse reactions, including decreased left ventricular ejection fraction (LVEF), ocular hypertension, and serious ocular toxicities such as retinal vein occlusion (RVO) and retinal pigment epithelial detachment (RPED). These safety concerns necessitate regular monitoring and may impact the drug's long-term market acceptance[5].

Competitive Landscape

Selumetinib is one of the few MEK inhibitors approved for NF1, but it operates in a competitive landscape where other MEK inhibitors and treatments for NF1 are under investigation. The ongoing clinical trials for other MEK inhibitors, such as mirdametinib, could potentially alter the market dynamics in the future[1].

Financial Projections and Revenue Potential

Despite the high costs and cost-effectiveness challenges, selumetinib's approval in a niche market with significant unmet need suggests a potential for substantial revenue. However, the financial trajectory will depend on pricing strategies, reimbursement policies, and the emergence of competing therapies. The drug's orphan drug status in several jurisdictions may also influence its revenue potential through exclusive market rights and incentives[2][4].

Key Takeaways

• Approval and Indications: Selumetinib is approved for pediatric patients with NF1 and symptomatic, inoperable plexiform neurofibromas.
• Cost-Effectiveness: The drug is not cost-effective at standard thresholds, requiring significant price reductions for public healthcare reimbursement.
• Pricing and Costs: High annual costs associated with the treatment pose a challenge for market access.
• Safety Profile: Associated with adverse reactions including cardiac and ocular toxicities.
• Competitive Landscape: Operates in a niche market with potential competition from other MEK inhibitors.
• Financial Projections: Revenue potential is significant but dependent on pricing, reimbursement, and competitive landscape.

FAQs

Q: What is the primary indication for selumetinib sulfate (Koselugo)?

A: Selumetinib sulfate is indicated for the treatment of pediatric patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)[1][2].

Q: When was selumetinib approved by the FDA and Health Canada?

A: Selumetinib was approved by the FDA on April 10, 2020, and by Health Canada on August 23, 2022[2][4].

Q: What are the main cost-effectiveness concerns with selumetinib?

A: Selumetinib is not cost-effective at a willingness-to-pay threshold of $50,000 per QALY gained, requiring significant price reductions to be considered cost-effective[3].

Q: What are the common adverse reactions associated with selumetinib?

A: Common adverse reactions include decreased left ventricular ejection fraction (LVEF), ocular hypertension, and serious ocular toxicities such as retinal vein occlusion (RVO) and retinal pigment epithelial detachment (RPED)[5].

Q: How does the pricing of selumetinib impact its market access?

A: The high pricing of selumetinib poses a significant challenge for market access and reimbursement by public healthcare systems, necessitating substantial price reductions for it to be considered cost-effective[3].

Sources:

1. Australian public assessment report for Koselugo - Therapeutic Goods Administration.
2. Selumetinib sulfate - DrugBank Online.
3. Pharmacoeconomic Review - Selumetinib (Koselugo) - NCBI.
4. Selumetinib sulfate - Synapse.
5. KOSELUGO (selumetinib) - FDA.