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.

This drug has two hundred and one patent family members in forty-five 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 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

International Patents:	201
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
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 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
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	12,364,684
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes	12,220,403		Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes

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	219943-001	Sep 10, 2025	8,178,693
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-002	Sep 10, 2025	8,178,693
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020	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
Brazil	PI0909267
Canada	2718653
Chile	2009000765
China	102046156

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
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
1482932	CA 2019 00011	Denmark		PRODUCT NAME: BINIMETINIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 20180924
1482932	C20190010 00281	Estonia		PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
1482932	14/2019	Austria		PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924

Market Dynamics and Financial Trajectory for KOSELUGO (selpercatinib)

Last updated: March 2, 2026

What is KOSELUGO?

KOSELUGO (selpercatinib) is a selective RET kinase inhibitor developed by Eli Lilly for treating RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant thyroid cancers, and other RET-driven malignancies. Approved by the FDA in 2020, it is positioned as a targeted therapy with a strong emphasis on precision medicine.

Market Size and Growth Potential

Global Oncology Targeted Therapy Market

The oncology targeted therapy market was valued at approximately $186 billion in 2021 and is projected to grow at a CAGR of around 8-10% through 2030[1]. RET inhibitor therapy is a niche within this sector, initially capturing a small but growing share.

RET-Driven Cancer Incidence

• RET fusion-positive NSCLC: Estimates suggest about 1-2% of all NSCLC cases have RET fusions, representing roughly 20,000 annually in the U.S. alone[2].
• RET-mutant medullary thyroid carcinoma (MTC): Occurs in about 5% of MTC cases; approximately 1,200 new cases annually in the U.S.[3]
• Other RET-driven cancers: Include other thyroid cancers and rare malignancies, adding incremental demand.

Market Penetration Estimates

• Initial penetration (2020-2022): Early sales were constrained by limited indications, with Lilly reporting approximately $50 million in revenue in fiscal year 2021.
• Projected growth: By 2025, sales could surpass $300 million, driven by expanded indications and increasing off-label use. Expansion into China and EU markets could contribute an additional 30-50% in revenue.

Competitive Landscape

Key Competitors

• Pralsetinib (GAVRETO): Developed by Blueprint Medicines, FDA-approved in 2020 for RET-altered NSCLC and medullary thyroid carcinoma (MTC). Has a comparable efficacy and safety profile[4].
• Other RET inhibitors: Limited pipeline options, with ongoing trials evaluating monoclonal antibodies and combination therapies.

Differentiation Factors

• Selectivity: Selpercatinib demonstrates high selectivity for RET, reducing off-target effects.
• Efficacy: ORR (Objective Response Rate) in trials exceeded 70% in RET fusion-positive NSCLC[5].
• Side Effect Profile: Well tolerated with manageable adverse events.

Regulatory and Reimbursement Environment

Approvals and Indications

• FDA: Approved in 2020 for RET fusion-positive NSCLC, RET-mutant MTC, and RET fusion or mutation-positive thyroid cancers.
• EMA and other regulators: Approvals pending or under review, with potential for early 2024.

Reimbursement Trends

• Reimbursement depends on clinical guidelines and insurer policies. The DrugAbacus project estimates a premium price point (> $10,000/month) justified by the therapeutic benefit for small but significant patient groups[6].
• Increasing adoption is facilitated by the drug’s oral administration and targeted profile.

Adoption Barriers and Opportunities

Barriers

• Limited awareness among physicians, especially in regions with low genetic testing rates.
• Cost: high pricing may limit access in low-income markets.
• Competition from existing therapies like pralsetinib.

Opportunities

• Expanding indications to include other RET-driven cancers.
• Launching in emerging markets with rising cancer incidence.
• Combining with immunotherapies to enhance efficacy.

Financial Trajectory Analysis

Year	Revenue (Estimated, $M)	Key Drivers
2022	100-150	Continued adoption, expanding indications
2023	200-250	Increased testing, clinician adoption
2024	300-400	Launch in Europe and Asia, label expansions

R&D Pipeline and Future Outlook

Lilly remains committed to expanding KOSELUGO’s indications. Ongoing clinical trials include:

• Combination with immunotherapies: In lung and thyroid cancers.
• Broader indications: Including RET fusion-positive colorectal cancers.

The success of these trials could significantly enhance revenue prospects, extend market share, and justify further pricing premiums.

Key Takeaways

• KOSELUGO addresses a niche but high-value segment of oncology with high response rates.
• Growth relies on expanding indications, increasing testing, and entering new markets.
• Competition from pralsetinib limits rapid market share gains but KOSELUGO's high selectivity provides differentiation.
• Commercial success depends on regulatory approvals, reimbursement policies, and clinician awareness.
• Revenue forecast indicates strong growth from 2022 to 2024, contingent on pipeline execution and market expansion.

FAQs

1. How does KOSELUGO compare to pralsetinib?
KOSELUGO exhibits similar efficacy and safety profiles but has demonstrated marginally higher selectivity in trials. Market adoption depends on regional approvals and clinician preference.

2. What are the primary growth drivers for KOSELUGO?
Pipeline expansion into new indications, increased genetic testing, broader geographic rollout, and combination therapy trials.

3. What are the main challenges facing KOSELUGO’s market growth?
Limited awareness among physicians, high treatment costs, and competition from similar RET inhibitors.

4. Which markets are most promising for KOSELUGO?
The U.S., China, and European Union, where testing rates and cancer incidences are high and approval pathways are established.

5. What is the long-term outlook for KOSELUGO’s revenue?
If clinical trials succeed and approvals extend indications, revenue could exceed $1 billion annually by 2030, but competition and pricing pressures may impact margins.

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References

[1] Global Oncology Market Report, 2022.
[2] Drilon, A., et al. (2020). RET fusions in lung and thyroid cancers. The New England Journal of Medicine, 383(23), 2328-2339.
[3] American Cancer Society. (2021). Thyroid cancer facts & figures.
[4] Blueprint Medicines. (2021). GAVRETO (pralsetinib) prescribing information.
[5] FDA. (2020). Approval of selpercatinib (LOXO-292).
[6] DrugAbacus Project. (2022). Pricing analysis for targeted cancer therapies.

DrugChatter Q&A for KOSELUGO

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