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 two NDAs. There are eight patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in KOSELUGO is selumetinib sulfate. There is one drug master file entry for this compound. 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 November 19, 2032. 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 KOSELUGO

US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	12
Patent Applications:	5,974
Drug Prices:	Drug price information for KOSELUGO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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:

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

NDA:

213756

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)

NDA:

219943

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 KOSELUGO

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

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

Paragraph IV (Patent) Challenges for KOSELUGO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KOSELUGO	Capsules	selumetinib sulfate	10 mg and 25 mg	213756	1	2026-08-04

US Patents and Regulatory Information for KOSELUGO

KOSELUGO is protected by eight US patents and seven FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS 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	GRANULE;ORAL	219943-001	Sep 10, 2025		RX	Yes	Yes
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-001	Sep 10, 2025		RX	Yes	Yes	8,178,693		Y	Y
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-002	Sep 10, 2025		RX	Yes	No	9,562,017			Y

Expired US Patents for KOSELUGO

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	219943-002	Sep 10, 2025	8,178,693
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-001	Sep 10, 2025	8,178,693

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

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Japan

Malaysia

Mexico

New Zealand

Peru

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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
Argentina	071100
Argentina	116001
Australia	2009229204

Supplementary Protection Certificates for KOSELUGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	PA2019007	Lithuania		PRODUCT NAME: BINIMETINIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1315 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	300974	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME

KOSELUGO Market Dynamics and Financial Trajectory: Selumetinib Revenue, Competition, Exclusivity, and Commercial Outlook

Last updated: August 11, 2026

Koselugo, AstraZeneca’s selumetinib, is the first FDA-approved systemic therapy for pediatric patients with neurofibromatosis type 1-associated symptomatic, inoperable plexiform neurofibromas. Its commercial profile is driven by a concentrated rare-disease population, durable treatment use, limited approved competition, and international expansion. AstraZeneca reported product sales growth from roughly $45 million in 2020 to approximately $310 million in 2023, establishing Koselugo as a meaningful specialty-medicines asset despite its narrow indication.[1]

The principal medium-term risks are market saturation in diagnosed pediatric patients, payer scrutiny over high treatment costs, treatment discontinuation, and the eventual arrival of competing MEK inhibitors or generic selumetinib. FDA orphan-drug exclusivity runs through April 10, 2027, while patent protection may extend beyond that date depending on the applicable Orange Book listings and patent-term adjustments.[2]

What is Koselugo and which patients does it treat?

Koselugo is an oral formulation of selumetinib, a selective inhibitor of MEK1 and MEK2. AstraZeneca markets the drug for patients aged 2 years and older with neurofibromatosis type 1, or NF1, who have symptomatic, inoperable plexiform neurofibromas, or PN.[3]

NF1 is a genetic disorder caused primarily by pathogenic variants in the NF1 gene. The condition affects approximately one in 3,000 people. Plexiform neurofibromas occur in roughly 30% to 50% of NF1 patients, although the subset that is symptomatic, progressive, and inoperable is materially smaller.[4]

Koselugo’s value proposition rests on tumor shrinkage and functional improvement. In the pivotal SPRINT study, 70% of pediatric patients achieved a confirmed partial response, defined as at least 20% tumor-volume reduction, and responses were generally durable.[5]

Attribute	Koselugo
Active ingredient	Selumetinib
Drug class	MEK1/2 inhibitor
Sponsor	AstraZeneca
FDA application	NDA 213756
Initial FDA approval	April 10, 2020
Indication	NF1-associated symptomatic, inoperable PN
Approved age	2 years and older
Administration	Oral capsules, twice daily
Key trial	SPRINT Phase II
Regulatory designation	Orphan drug
Primary commercial market	Pediatric and young-adult NF1 patients

How has Koselugo revenue changed since launch?

Koselugo revenue has followed the typical rare-disease launch curve: a rapid percentage increase from a small base, followed by broader international adoption and a transition toward a more mature specialty product.

AstraZeneca reported approximately $45 million in Koselugo sales during the partial launch period in 2020. Revenue increased to about $141 million in 2021, approximately $214 million in 2022, and approximately $310 million in 2023.[1]

Fiscal year	Approximate Koselugo product sales	Primary growth drivers
2020	$45 million	U.S. launch and initial specialist adoption
2021	$141 million	U.S. patient identification and European rollout
2022	$214 million	International reimbursement and treatment-center expansion
2023	$310 million	Continued geographic growth and broader diagnosis
2024 onward	Not included in this historical series	Dependent on new reported company filings

The increase from 2020 to 2023 represents a roughly sevenfold expansion in annual sales. Growth has come from several sources:

1. More systematic identification of NF1 patients with symptomatic PN.
2. Increased referrals to specialized neurofibromatosis and pediatric oncology centers.
3. Broader reimbursement coverage after initial launches.
4. Longer treatment duration among patients who tolerate therapy and maintain clinical benefit.
5. Regulatory expansion outside the United States.

Koselugo remains small relative to AstraZeneca’s oncology blockbusters, but its rare-disease economics are strategically attractive. The product uses an established specialty commercial infrastructure and addresses a population with limited treatment alternatives.

What is the market size for Koselugo?

The addressable market is constrained by the biology of NF1 and the treatment criteria. Not every NF1 patient develops PN, and not every patient with PN has symptoms severe enough to require systemic treatment. Surgical resection remains appropriate for selected tumors, while other patients are managed through observation, pain control, rehabilitation, or treatment of functional complications.

The commercial market has three layers:

Market layer	Patient characteristics	Commercial implication
Broad NF1 population	All patients with NF1	Large epidemiological pool but not a drug-treated market
PN population	NF1 patients with plexiform neurofibromas	Screening and diagnosis opportunity
Koselugo-eligible population	Symptomatic, inoperable PN in patients aged 2+	Core treated market

The United States is the most important market because of its concentration of specialist centers, earlier access to orphan drugs, and high commercial pricing. Europe and Japan provide additional volume but generally impose more stringent health-technology assessment and reimbursement controls.

Market expansion depends less on conventional primary-care prescribing than on specialist diagnosis. Treatment decisions are concentrated among pediatric oncologists, neurologists, NF1 specialists, surgeons, and multidisciplinary centers. Patient registries and long-term follow-up programs are commercially relevant because they can identify untreated or undertreated patients.

What is the price and economic value of Koselugo?

Koselugo pricing is weight- and body-surface-area-dependent because the recommended dose is 25 mg per square meter taken orally twice daily. The resulting annual treatment cost varies by patient size, dose interruptions, payer discounts, and duration of therapy.

Public U.S. list-price estimates have generally placed annual treatment cost in the high five figures to low six figures, with actual net sales affected by rebates, patient-support programs, Medicaid discounts, and other contracting arrangements. Rare-disease reimbursement is typically strongest when the patient meets the labeled criteria and treatment is prescribed through an experienced center.

The economic value case is based on:

• Reduction in tumor volume.
• Improvement in pain, mobility, and physical function.
• Avoidance or delay of high-risk surgery.
• Reduction in tumor-related morbidity.
• Durable response in a portion of treated patients.

Payers may challenge treatment when tumor growth is slow, symptoms are modest, imaging response does not translate into functional benefit, or long-term treatment is required without clear incremental improvement.

What is the FDA regulatory status of Koselugo?

The FDA approved Koselugo on April 10, 2020, under the accelerated approval pathway based on overall response rate and durability of response in the SPRINT study.[3] The approval was supported by a confirmatory clinical program and long-term follow-up.

The FDA label requires monitoring for cardiac toxicity, ocular toxicity, liver-related laboratory abnormalities, gastrointestinal effects, dermatologic reactions, and creatine phosphokinase elevation.[3] These safety requirements create clinical-management costs and can affect persistence.

Koselugo also received orphan-drug designation. The orphan exclusivity period runs for seven years from FDA approval, ending on April 10, 2027, unless the exclusivity is affected by statutory exceptions or another product demonstrates clinical superiority for the same indication.[2]

The European Commission authorized Koselugo for pediatric patients aged 3 years and older with symptomatic, inoperable PN in NF1. The age threshold and regulatory wording differ from the U.S. label.[6]

What patents protect Koselugo and when does it lose exclusivity?

Koselugo is protected by a combination of regulatory exclusivity, compound and formulation patents, and patents covering pharmaceutical compositions or therapeutic use. The FDA Orange Book lists patents associated with NDA 213756, and those listings are relevant to any abbreviated new drug application, or ANDA, strategy.[7]

The most certain publicly established exclusivity date is the orphan-drug exclusivity expiration on April 10, 2027. Patent expiration may occur later, depending on:

• The specific Orange Book-listed patent.
• Patent-term adjustment.
• Patent-term extension.
• Pediatric exclusivity.
• The scope of the claimed formulation or method of use.
• Whether a generic applicant files a Paragraph IV certification.

Because selumetinib is a small molecule, biosimilar competition is not the relevant pathway. The principal post-exclusivity threat is generic competition through an ANDA.

How strong is the Koselugo patent estate?

The estate is commercially meaningful but does not create the same barrier as a complex biologic or a highly specialized delivery platform. Selumetinib is an orally administered small molecule with a conventional capsule dosage form. Generic developers can potentially pursue active-ingredient, formulation, and method-of-use strategies once regulatory and patent barriers permit.

The strongest protection is likely to come from the combination of:

• FDA orphan exclusivity through 2027.
• Remaining Orange Book-listed patents.
• Regulatory requirements for demonstrating bioequivalence.
• Limited commercial scale of the eligible market.
• Clinical and manufacturing know-how around product quality and capsule formulation.

A small market can delay generic entry because the expected return may not justify development, patent litigation, and launch costs. That economic barrier may be more important than the underlying formulation complexity.

Has Koselugo faced Paragraph IV challenges or patent litigation?

Publicly available information through June 2024 did not establish a major, widely reported ANDA litigation campaign against Koselugo comparable to litigation involving large primary-care products. The absence of a prominent Paragraph IV case is consistent with the product’s relatively small market and remaining orphan exclusivity.

A future generic applicant could challenge listed patents through a Paragraph IV certification. AstraZeneca could then file an infringement action, potentially triggering a 30-month stay of FDA approval under the Hatch-Waxman framework.[8]

The commercial significance of a Paragraph IV filing would depend on:

• The patent claims challenged.
• Whether the applicant seeks approval for the full label or a carve-out indication.
• The remaining term of the challenged patent.
• The strength of AstraZeneca’s infringement and validity positions.
• Whether the parties settle before trial.

What generic launch risks exist for Koselugo?

The earliest practical generic launch scenario is more likely to be tied to the end of enforceable patent protection than to the orphan-exclusivity date alone. A generic could theoretically receive approval after orphan exclusivity expires if no blocking patent remains, but an Orange Book-listed patent could delay approval.

Potential launch scenarios include:

Scenario	Timing logic	Market effect
No early challenge	Generic waits for patent expiry	Gradual erosion after launch
Paragraph IV challenge	Litigation begins before patent expiry	Possible settlement or accelerated entry
Authorized generic	AstraZeneca or a partner launches a lower-priced version	Controlled erosion and price segmentation
Single generic entrant	One competitor enters first	Moderate price pressure
Multiple generics	Several ANDAs reach market	Rapid price erosion and volume substitution

NF1 treatment is specialist-driven, which can slow automatic substitution compared with high-volume retail drugs. Physician familiarity, patient support, dosing management, and payer policies may preserve some branded share after generic launch.

Which companies compete with Koselugo?

Koselugo has historically had limited direct FDA-approved competition for its labeled indication. Its main competitive set has included surgery, observation, clinical trials, and off-label use of other MEK inhibitors.

Relevant competitive products include:

• Mektovi, or binimetinib, marketed by Pfizer after its acquisition of Array BioPharma.
• Mekinist, or trametinib, marketed by Novartis.
• Cotellic, or cobimetinib, marketed by Roche.
• Investigational MEK inhibitors developed for NF1-associated PN.
• Surgical intervention for resectable tumors.

These alternatives do not have the same regulatory position as Koselugo in the U.S. NF1-PN indication. Their competitive impact depends on physician experience, clinical evidence, reimbursement, tolerability, and the availability of trial access.

The competitive landscape could change materially if another MEK inhibitor demonstrates comparable tumor response with improved dosing convenience, fewer ocular or cardiac monitoring requirements, or better long-term tolerability.

How does Koselugo compare with other AstraZeneca oncology products?

Koselugo is strategically different from AstraZeneca’s large oncology products such as Tagrisso, Imfinzi, Lynparza, and Calquence.

Factor	Koselugo	Large AstraZeneca oncology products
Disease population	Rare, genetically defined	Larger cancer populations
Prescribing base	Specialized centers	Broad oncology networks
Revenue scale	Hundreds of millions of dollars	Several billion dollars for leading brands
Reimbursement	Orphan and specialty pharmacy	Complex oncology reimbursement
Competition	Limited labeled competition	Multiple targeted and immuno-oncology competitors
Generic risk	Delayed but potentially material	Often offset by lifecycle management
Growth driver	Diagnosis and international access	Biomarker expansion and line extensions

Koselugo’s revenue contribution is modest within AstraZeneca’s portfolio, but its growth rate and orphan-drug profile improve portfolio diversification. The drug also gives AstraZeneca a commercial position in NF1, a disease area with potential opportunities for combination research and broader neurofibromatosis development.

What licensing deal brought selumetinib to AstraZeneca?

AstraZeneca obtained rights to selumetinib through an agreement with Array BioPharma in 2013. The transaction gave AstraZeneca worldwide rights to develop and commercialize selumetinib and included upfront and milestone economics.[9]

AstraZeneca later acquired Array BioPharma in 2019. That acquisition consolidated ownership and development control over Array’s oncology assets, including selumetinib-related rights. The transaction also reduced the need for an ongoing external licensing structure for the product.

What is the geographic coverage of Koselugo?

Koselugo has been approved in the United States, European Union, Japan, and other markets. Geographic expansion depends on local regulatory approvals, reimbursement negotiations, pediatric treatment infrastructure, and the presence of NF1 referral centers.

The commercial opportunity is strongest where:

• NF1 diagnosis is established.
• Pediatric oncology networks are concentrated.
• Orphan-drug reimbursement is available.
• MRI monitoring and multidisciplinary care are accessible.
• Specialty pharmacies can manage chronic oral therapy.

Emerging-market sales are likely to remain limited unless AstraZeneca establishes local reimbursement and distribution arrangements. The drug’s cost, monitoring requirements, and narrow indication restrict broad access in lower-income markets.

What manufacturing and intellectual-property barriers affect Koselugo?

Koselugo does not depend on a biologic manufacturing process, cold-chain infrastructure, or a proprietary injection device. Its oral capsule format reduces technical barriers to replication compared with biologic medicines.

Manufacturing barriers still include:

• Consistent production of pharmaceutical-grade selumetinib.
• Control of impurities and degradation products.
• Capsule-content uniformity.
• Stability and dissolution performance.
• Bioequivalence across the relevant strength range.
• Compliance with FDA and international current good manufacturing practices.

The most important intellectual-property barrier is the interaction between active patent claims, formulation claims, method-of-use claims, and FDA approval requirements. A generic applicant may seek a label carve-out for patented use, but commercial viability depends on whether the remaining non-patented use is meaningful.

What is the long-term financial outlook for Koselugo?

Koselugo’s growth should moderate as the initial launch population becomes increasingly penetrated. Revenue can continue to expand through international launches, earlier diagnosis, treatment of younger children, and longer duration of therapy.

The principal financial variables are:

1. Patient starts in the United States.
2. Average treatment duration.
3. Net price after rebates and discounts.
4. International reimbursement.
5. Treatment discontinuation caused by toxicity or inadequate response.
6. New MEK-inhibitor competition.
7. Generic entry after patent and regulatory exclusivity expire.

A reasonable commercial framework is:

Period	Expected financial dynamic
2024 to 2026	Continued growth, with international access and diagnosis as key drivers
2027	Orphan-exclusivity expiration creates a strategic inflection point
2027 onward	Patent status and generic filings determine erosion speed
Longer term	Mature specialty product unless a new indication or formulation expands the market

The product’s revenue exposure is meaningful for AstraZeneca’s rare-disease and specialty portfolio but remains limited relative to the company’s largest oncology franchises. The main valuation issue is whether Koselugo can maintain several hundred million dollars in annual sales after orphan exclusivity expires.

Key Takeaways

• Koselugo is AstraZeneca’s selumetinib product for symptomatic, inoperable NF1-associated plexiform neurofibromas.
• FDA approval occurred on April 10, 2020.
• AstraZeneca reported sales growth from approximately $45 million in 2020 to approximately $310 million in 2023.
• The core market is a small, highly specialized pediatric and young-adult population.
• Orphan-drug exclusivity expires on April 10, 2027.
• Generic competition, rather than biosimilar competition, is the principal post-exclusivity risk.
• No major publicly reported Paragraph IV litigation was established through June 2024.
• Koselugo’s commercial upside depends on diagnosis, international reimbursement, treatment persistence, and expansion of specialist access.
• The financial inflection point is the period surrounding 2027, when orphan exclusivity ends and patent enforcement becomes more important.

FAQs About Koselugo Market and Exclusivity

How long do patients typically remain on Koselugo?

Treatment duration varies by response, disease progression, toxicity, and clinical benefit. Patients with durable tumor shrinkage and functional improvement may remain on treatment for multiple years.

Is Koselugo a chemotherapy drug?

No. Koselugo is a targeted MEK1/2 inhibitor. It blocks signaling in the RAS/MAPK pathway, which is dysregulated in NF1-associated tumors.

Can adults use Koselugo for NF1 plexiform neurofibromas?

The U.S. label covers patients aged 2 years and older, so adults may qualify when they meet the indication criteria. Prescribing depends on tumor symptoms, resectability, prior treatment, and medical judgment.

What would most increase Koselugo sales?

The strongest growth levers are earlier NF1 diagnosis, increased identification of symptomatic PN, broader reimbursement, international market access, and evidence supporting treatment in additional patient subgroups.

Is a generic version of Koselugo available?

No broadly marketed generic version was established in the referenced period. Future generic availability will depend on FDA approval, Orange Book-listed patent expiry or resolution, and any Paragraph IV litigation or settlement.

References

1. AstraZeneca PLC. (2021-2024). Annual reports and full-year results. AstraZeneca.

2. U.S. Food and Drug Administration. (2020). Koselugo approval letter and orphan-drug exclusivity information for NDA 213756. FDA.

3. U.S. Food and Drug Administration. (2023). Koselugo prescribing information. FDA.

4. U.S. National Institutes of Health, National Human Genome Research Institute. (2024). Neurofibromatosis type 1. MedlinePlus Genetics.

5. Gross, A. M., Wolters, P. L., Dombi, E., et al. (2020). Selumetinib in adults and children with NF1-associated plexiform neurofibromas. New England Journal of Medicine, 382(15), 1430-1442.

6. European Medicines Agency. (2021). Koselugo: EPAR product information. EMA.

7. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

8. U.S. Code, 21 U.S.C. § 355(j). Abbreviated new drug applications and patent certifications.

9. AstraZeneca PLC. (2013). AstraZeneca and Array BioPharma enter worldwide collaboration for selumetinib. AstraZeneca.

DrugChatter Q&A for KOSELUGO

Koselugo selumetinib fda approval date 2020?