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 two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selumetinib sulfate has two hundred and one patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for SELUMETINIB SULFATE

International Patents:	201
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	37
Patent Applications:	297
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SELUMETINIB SULFATE
DailyMed Link:	SELUMETINIB SULFATE at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Dosage:

GRANULE;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
Sarcoma Alliance for Research through Collaboration	Phase 2
United States Department of Defense	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	GRANULE;ORAL	219943-001	Sep 10, 2025		RX	Yes	Yes
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	12,318,367		Y

Expired US Patents for SELUMETINIB SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020	8,178,693
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-001	Sep 10, 2025	8,178,693
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-002	Sep 10, 2025	8,178,693

International Patents for SELUMETINIB SULFATE

Country	Patent Number	Title	Estimated Expiration
Argentina	071100
Argentina	116001
Australia	2009229204

Supplementary Protection Certificates for SELUMETINIB SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1968948	C01968948/01	Switzerland		PRODUCT NAME: SELUMETINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67410 29.07.2022
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	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

Market Dynamics and Financial Trajectory for Selumetinib Sulfate

Last updated: March 2, 2026

What is Selumetinib Sulfate?

Selumetinib sulfate is an oral MEK1/2 inhibitor developed by AstraZeneca. It is primarily investigated for treating cancers with abnormal MAPK pathway activation, including neurofibromatosis type 1 (NF1) associated plexiform neurofibromas and certain solid tumors.

Current Regulatory Status and Approvals

Region	Status	Date	Indication
United States	FDA approved	April 2021	Pediatric NF1 with plexiform neurofibromas
European Union	Under review	Ongoing	NF1 neurofibromas

In the U.S., the FDA granted accelerated approval for selumetinib in children's NF1 tumors, with confirmatory trials ongoing. Regulatory submissions are in progress in Europe for similar indications.

Market Segments and Adoption Drivers

Oncology and NF1

Selumetinib's approved use in pediatric NF1 has driven initial adoption, with a focus on rare genetic tumors. Its off-label potential extends to other tumors with MAPK pathway activation.

Competitive Landscape

Competitors	Mechanism of Action	Status	Indications
Trametinib (GSK)	MEK inhibitor	Approved	Melanoma, NSCLC
Binimetinib (Pfizer)	MEK inhibitor	Approved	Melanoma

Selumetinib faces competition from other MEK inhibitors, but its unique pediatric indication limits market overlap.

Pipeline and Partnerships

AstraZeneca's pipeline includes clinical trials for various tumors, expanding potential indications:

• Non-small cell lung cancer (NSCLC)
• Ovarian cancer
• Combination therapies with BRAF inhibitors

Partnerships with biotech firms and academic institutions accelerate development.

Market Size and Revenue Trajectory

Historical and Projected Revenues

Year	Revenue (USD million)	Notes
2021	50	U.S. launch for NF1
2022	150	Revenue growth as prescriptions increase
2023 (forecast)	300	Expanded indications and supply chain ramp-up

The initial revenue release in 2021 was modest, reflecting the orphan drug designation's limited patient pool. Growth projections assume expanded clinical trials and eventual approvals for additional indications.

Market Size Estimation

• Pediatric NF1: Estimated 3,000 patients in the U.S.; global count around 8,000
• Additional indications: Estimated 120,000 patients globally for advanced solid tumors

Assuming a price point averaging USD 100,000 per treatment course, market potential exceeds USD 1.2 billion across all indications.

Pricing and Reimbursement Landscape

Pricing varies by region and indication:

• U.S.: USD 100,000 – 125,000 per treatment course
• Europe: Slightly lower due to negotiated reimbursement policies

Reimbursement depends on health technology assessments and payor negotiations. Orphan designation facilitates favorable pricing in some jurisdictions but limits volume.

Key Risks and Challenges

• Regulatory approval delays or denials for expanded indications
• Competition from emerging targeted therapies
• Limited patient populations for orphan indications
• Pricing pressures and reimbursement hurdles

Financial Outlook and Strategic Considerations

Revenue Growth Drivers

• Expansion into additional cancer indications
• Improved survey and reporting of off-label and compassionate use
• Global market penetration, particularly in Europe and Asia

Investment Focus

• Accelerating pipeline candidates to capitalize on broader oncology applications
• Strengthening partnerships with payors and healthcare providers
• Investing in pharmacoeconomic studies to support reimbursement

Sensitivity to Market Changes

Selumetinib's revenue is sensitive to regulatory timelines, competitive advances, and pricing reforms. Strategic agility remains crucial.

Key Takeaways

• Selumetinib sulfate has achieved regulatory approval in the pediatric NF1 segment; revenue remains modest but shows growth potential.
• The firm's pipeline presents opportunities for broader oncology indications, with projected revenues potentially exceeding USD 1 billion globally.
• Competition from other MEK inhibitors and orphan drug market limitations impose significant challenges.
• Pricing strategies and reimbursement negotiations will influence long-term financial trajectories.
• Continued clinical development and strategic partnerships are key to capturing additional market share.

Frequently Asked Questions

1. What are the primary drivers for selumetinib's market growth?
Expansion into additional cancer indications, increased global approval, and pipeline advancements drive growth.

2. Which competitors pose the greatest challenge?
Trametinib and binimetinib, both approved MEK inhibitors, compete in broader oncology markets but have limited overlap with pediatric NF1.

3. How does orphan drug designation affect revenue potential?
It limits patient populations but allows for premium pricing, balancing limited volume against high margins.

4. What regions are key for selumetinib adoption?
The U.S., Europe, and increasingly Asian markets are prime targets, depending on regulatory progress.

5. What strategies can AstraZeneca pursue to maximize revenue?
Pipeline expansion, strategic licensing, and securing favorable reimbursement deals are critical.

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References

1. Food and Drug Administration. (2021). FDA approves first treatment for children with neurofibromatosis type 1. FDA Press Release.
2. AstraZeneca. (2022). Selumetinib (AZD6244) pipeline data. Corporate Reports.
3. Market Research Future. (2023). MEK inhibitors market analysis.
4. European Medicines Agency. (Pending). Selumetinib review status updates.
5. EvaluatePharma. (2023). Oncology drug market forecasts.