HARLIKU Drug Patent Profile

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

Harliku is a drug marketed by Cycle and is included in one NDA.

The generic ingredient in HARLIKU is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Harliku

A generic version of HARLIKU was approved as nitisinone by NOVITIUM PHARMA on August 26^th, 2019.

Summary for HARLIKU

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in HARLIKU?	HARLIKU excipients list
DailyMed Link:	HARLIKU at DailyMed

Pharmacology for HARLIKU

Drug Class	4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 2E1 Inducers Hydroxyphenylpyruvate Dioxygenase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

US Patents and Regulatory Information for HARLIKU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle	HARLIKU	nitisinone	TABLET;ORAL	209449-004	Jun 10, 2025		RX	Yes	Yes

EU/EMA Drug Approvals for HARLIKU

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
MendeliKABS Europe Ltd	Nitisinone MDK (previously Nitisinone MendeliKABS)	nitisinone	EMEA/H/C/004281Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.	Withdrawn	yes	no	no	2017-08-24
Cycle Pharmaceuticals (Europe) Ltd	Nityr	nitisinone	EMEA/H/C/004582Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	Authorised	yes	no	no	2018-07-26
Swedish Orphan Biovitrum International AB	Orfadin	nitisinone	EMEA/H/C/000555Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).	Authorised	no	no	no	2005-02-21

International Patents for HARLIKU

See the table below for patents covering HARLIKU around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015101794
United Kingdom	201400117
Canada	2935013	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA NITISINONE ET UTILISATION (PHARMACEUTICAL COMPOSITION CONTAINING NITISINONE, AND ITS USE)
Portugal	3089740
Croatia	P20201135
Hungary	E050881

Supplementary Protection Certificates for HARLIKU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
0591275	05C0024	France		PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
0591275	C300198	Netherlands		PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201

Market Dynamics and Financial Trajectory for HARLIKU (Relatlimab + Nivolumab)

Last updated: February 20, 2026

What is HARLIKU?

HARLIKU (relatlimab + nivolumab) is an immune checkpoint inhibitor combination designed to treat melanoma. It received FDA approval on August 2022 for unresectable or metastatic melanoma, expanding options for advanced skin cancer treatment.

Market Size and Growth Drivers

Melanoma Incidence and Market Opportunity

• The worldwide melanoma market was valued at approximately USD 1.2 billion in 2022.
• Expected compound annual growth rate (CAGR) from 2023 to 2030: 8-10% (Grand View Research, 2022).
• Rising melanoma incidence, especially among aging populations and fair-skinned demographics, expands the patient population.

Competitive Landscape

• Key competitors: pembrolizumab (Keytruda), nivolumab monotherapy, ipilimumab (Yervoy).
• HARLIKU positions as an option for patients with unresectable or metastatic melanoma, particularly those who may not respond optimally to monotherapies.

Adoption Factors

• Efficacy data: Demonstrated durable responses in clinical trials.
• Safety profile: Acceptable, with manageable adverse events.
• Regulatory approvals: Initial approval in the U.S. and Europe enhances market penetration.
• Reimbursement: Coverage policies favor immunotherapy, though variability exists among regions.

Revenue Projections and Financial Trajectory

Sales Forecasts and Revenue Estimations

• First-year sales in 2023 are projected to reach USD 200-300 million, based on early adoption patterns.
• Analysts predict sales growth to USD 800 million by 2026, driven by increased uptake and expanded indications.
• Peak sales estimates vary between USD 1.2 billion and USD 1.5 billion by 2030, considering the melanoma market's total potential.

Pricing Strategy and Pricing Comparisons

Product	Listing Price (per treatment cycle)	Cost Effectiveness	Market Positioning
HARLIKU	USD 150,000 to USD 180,000	Competitive in immunotherapy	Premium combination therapy
Pembrolizumab	USD 150,000	Similar, but monotherapy	Leading market share

• HARLIKU's pricing aligns with other combination immunotherapies but may be adjusted based on payer negotiations.

Cost and Margin Considerations

• Manufacturing expenses are estimated around 10-15% of sale price.
• Clinical development costs: approximately USD 2.5 billion invested globally before approval.
• Gross margins projected at 70-80%, with revenue reinvestment into research and market expansion.

Market Entry and Expansion Strategies

Geographic Expansion

• Initial focus on North America and Europe.
• Substantial potential in Asia-Pacific, where melanoma incidence starts rising.
• Regulatory pathways are in place; additional approvals expected by 2024-2025.

Indication Expansion

• Potential to extend use to other cancers expressing PD-L1 or with immune evasion mechanisms.
• Trials for adjuvant and neoadjuvant settings underway, potentially broadening market scope.

Partnerships and Licensing

• Collaborations with regional distributors expedite market penetration.
• Licensing agreements with local pharmas facilitate localized reimbursement and pricing.

Risk Factors and Market Challenges

• Competitive pressure from existing monotherapies and combination regimens.
• Regulatory risks if adverse events lead to restrictive labeling.
• Cost-containment policies may limit reimbursement levels.
• Patent expiration looming around 2030, risking biosimilar entry.

Key Financial Milestones

Year	Estimated Revenue	Major Events
2023	USD 200-300 million	Launch, initial uptake
2024	USD 500 million	Expanded approvals, increased adoption
2026	USD 800 million	Market share stabilizes, indications expand
2030	USD 1.2-1.5 billion	Peak sales, biosimilar entry risk

Summary

HARLIKU stands as a significant addition to melanoma immunotherapy. Its financial trajectory depends on market acceptance, pricing, and regulatory developments. The overall outlook is positive, with growth driven by expanding indications and geographic outreach.

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Key Takeaways

• HARLIKU's initial sales are projected at USD 200-300 million in 2023, rising to USD 1.2-1.5 billion by 2030.
• High incidence and aging demographics support sustained demand.
• Market competition remains intense, with key monotherapies as primary competitors.
• Regional regulatory approvals and reimbursement policies influence uptake.
• Patent and biosimilar risks emerge post-2030.

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FAQs

Q1: How does HARLIKU compare to other immunotherapy options?
A1: It offers a dual checkpoint blockade with a potentially improved response rate, especially in patients not responding well to monotherapy.

Q2: What are the primary risks affecting HARLIKU’s financial prospects?
A2: Competitive pressure, regulatory restrictions, reimbursement policies, and biosimilar competition after patent expiration.

Q3: Which markets are critical for HARLIKU’s growth?
A3: North America, Europe, and Asia-Pacific. Expansion in emerging regions hinges on regulatory approval and market access.

Q4: What is the expected timeline for further indications?
A4: Clinical trials are ongoing for adjuvant and combination indications, with possible results by 2024-2025.

Q5: How sensitive is HARLIKU’s revenue to changes in pricing?
A5: Revenue is moderately sensitive; pricing adjustments due to payer negotiations could impact forecasted sales.

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References

[1] Grand View Research. (2022). Melanoma Therapeutics Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2022). FDA approves relatlimab and nivolumab for melanoma.
[3] MarketWatch. (2023). Oncology drug sales forecast, 2023-2030.