LORLATINIB - Generic Drug Details

What are the generic sources for lorlatinib and what is the scope of freedom to operate?

Lorlatinib is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorlatinib has one hundred and twenty-five patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for LORLATINIB

International Patents:	125
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	46
What excipients (inactive ingredients) are in LORLATINIB?	LORLATINIB excipients list
DailyMed Link:	LORLATINIB at DailyMed

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

Constraining patent/regulatory exclusivity:

11,299,500

Dosage:

TABLET;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 LORLATINIB

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

Sponsor	Phase
Astellas Pharma Global Development, Inc.	PHASE1
Pfizer	EARLY_PHASE1
Nationwide Children's Hospital	EARLY_PHASE1

See all LORLATINIB clinical trials

Pharmacology for LORLATINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Kinase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Organic Cation Transporter 1 Inhibitors P-Glycoprotein Inducers

Anatomical Therapeutic Chemical (ATC) Classes for LORLATINIB

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for LORLATINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No	11,020,376		Y

EU/EMA Drug Approvals for LORLATINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Lorviqua	lorlatinib	EMEA/H/C/004646Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC whose disease has progressed after:alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; orcrizotinib and at least one other ALK TKI.	Authorised	no	no	no	2019-05-06

International Patents for LORLATINIB

Country	Patent Number	Title	Estimated Expiration
Denmark	2822953
Spain	2621220
Cyprus	2019033

Supplementary Protection Certificates for LORLATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	PA2019519	Lithuania		PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	301006	Netherlands		PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953	CR 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508

Market Dynamics and Financial Trajectory for Lorlatinib

Last updated: July 27, 2025

Introduction

Lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) inhibitor, has repositioned itself as a significant player in the targeted therapy segment of oncology, specifically for ALK-positive non-small cell lung cancer (NSCLC). Since its FDA approval in 2018, lorlatinib’s market trajectory has been shaped by evolving treatment landscapes, competitive dynamics, and patent considerations. This analysis offers a detailed overview of the current market environment and forecasts lorlatinib’s financial outlook within the pharmaceutical industry.

Pharmacological Profile and Clinical Positioning

Lorlatinib (commercially marketed as Lorbrena® in the U.S.) is characterized by its ability to penetrate the blood-brain barrier, making it effective against intracranial metastases—a common complication in ALK-positive NSCLC patients. Its mechanism involves irreversible inhibition of ALK and ROS1 kinases, contributing to superior efficacy in resistant disease states.

The drug’s pivotal trials, including the Phase 1/2 study (NP28761), evidenced a CNS response rate of approximately 64% in treatment-naïve ALK-positive NSCLC, establishing lorlatinib as a cornerstone therapy post-progression on first- or second-generation ALK inhibitors [1].

Market Dynamics

Epidemiological Drivers

The global incidence of NSCLC stands at approximately 2.2 million new cases annually. ALK rearrangements occur in 3-5% of NSCLC cases, translating to roughly 66,000-110,000 new patients globally per year. The increasing prevalence of ALK-positive NSCLC, coupled with early detection and improved diagnostics, directly amplifies lorlatinib’s target population.

Competitive Landscape

Lorlatinib’s primary competitors include earlier-generation ALK inhibitors like crizotinib, ceritinib, and alectinib, with newer agents such as brigatinib and ensartinib also vying for market share. The advent of second-generation ALK inhibitors initially displaced crizotinib from standard-of-care, but lorlatinib’s intracranial activity has positioned it for use after resistance to earlier agents.

Moreover, the approval of lorlatinib as a first-line therapy in ALK-positive NSCLC (since 2021 in certain jurisdictions) intensifies competitive pressures, potentially expanding its share but also inviting price competition and reimbursement challenges.

Regulatory and Reimbursement Factors

Key regulatory milestones, including EMA and FDA approvals, have facilitated lorlatinib’s market entry across various regions. However, reimbursement negotiations, especially in cost-sensitive markets like China and parts of Europe, influence sales trajectories. High treatment costs—estimated at over $15,000 per month—pose affordability barriers, impacting access and adoption rates.

Pricing and Patent Strategy

Lorlatinib’s pricing reflects its novel mechanism and clinical benefits, with premium pricing models common for breakthrough oncology drugs. Patent protections extend its exclusivity until the early 2030s, offering a window of market dominance. However, biosimilar and generic competitors may emerge post-patent expiration, pressurizing margins.

Market Penetration and Adoption Trends

In the U.S., lorlatinib is increasingly adopted as a second- or third-line therapy, with rapid uptake driven by compelling clinical data. Global markets display heterogeneity: while mature markets show steady growth, emerging economies are gradually increasing access, influenced by local regulatory approvals, healthcare infrastructure, and pricing negotiations.

Impact of Combination Therapies and Personalized Medicine

The trend toward combination therapies—integrating lorlatinib with other agents—may expand indications and improve outcomes. Additionally, companion diagnostics enhance patient selection, maximizing therapeutic efficacy and potentially boosting sales.

Financial Trajectory Projections

Current Revenue Status

In 2022, lorlatinib generated approximately $300 million in global sales, with U.S. sales accounting for nearly 70%. Sales growth is fueled by expanded indications and increased adoption as the standard second-line therapy.

Forecasted Growth

Analysts project a compound annual growth rate (CAGR) of 15-20% over the next five years, reaching $1.1 billion by 2027. This reflects:

• Expanded first-line approval increasing early utilization.
• Growth in treatment-naïve patient populations.
• Increasing penetration in European and Asian markets.
• Continued clinical validation supporting broader indications.

However, potential market saturation, upcoming patent expiries, and the advent of competing therapies could temper growth.

Market Risks and Opportunities

Risks include:

• Emergence of resistance mutations reducing drug efficacy.
• Competitive pressure from next-generation inhibitors.
• Regulatory delays or unfavorable reimbursement policies.

Opportunities encompass:

• Development of combination regimens extending indications.
• Expansion into other ALK-positive cancers.
• Developing personalized medicine frameworks maximized via biomarker stratification.

Regulatory and Patent Landscape Impact

Patent protections secure market exclusivity until approximately 2030, providing margin for revenue maximization. Ongoing clinical trials exploring lorlatinib’s utility in neuroblastoma and other malignancies present avenues for future revenue streams.

Post-patent, generic competitors are expected to challenge pricing and volumes, likely causing a decline of up to 50% in sales unless new indications or combination strategies are introduced.

Conclusion and Strategic Outlook

Lorlatinib’s market trajectory is robust, buoyed by clinical advantages and strategic positioning. The driver of long-term profitability will hinge on continued clinical validation, strategic pricing, and adaptability to competitive shifts. Industry stakeholders should monitor regulatory developments, technological innovations, and market access policies that could influence supply and demand dynamics.

Key Takeaways

• Targeted therapy niche: Lorlatinib commands a significant role in ALK-positive NSCLC treatment, especially for CNS metastases.
• Growth prospects: Estimated global sales could reach $1.1 billion by 2027, driven by expanded indications and regional penetration.
• Competitive environment: Although current patents provide exclusivity, impending biosimilar entries and emergence of competitors pose risks.
• Pricing strategies: Premium pricing sustains revenue, but affordability and reimbursement negotiations are critical.
• Future directions: Combination therapies and expansion into new cancer types could diversify revenue streams amid patent expiries and competitive pressures.

FAQs

1. What factors influence lorlatinib’s market success?
   Clinical efficacy, intracranial penetration, expansion into first-line therapy, pricing strategies, and regulatory approvals shape its market success.

2. How does lorlatinib compare to earlier ALK inhibitors?
   It offers superior CNS activity and efficacy in resistant cases, positioning it as a preferred option after initial ALK inhibitor failure or in combination regimens.

3. What are the key risks to lorlatinib’s market growth?
   Resistance development, competitive new therapies, patent expiry, and reimbursement barriers threaten growth trajectories.

4. When is lorlatinib expected to face generic competition?
   Patent protection extends into the early 2030s, after which biosimilar competitors may emerge, impacting profitability.

5. What opportunities exist beyond NSCLC for lorlatinib?
   Potential expansion into other ALK-driven cancers, combination therapy development, and personalized medicine approaches hold future promise.

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Sources:

[1] Shaw, A. T., et al., "Lorlatinib in Advanced ALK-Positive Non-Small-Cell Lung Cancer," The New England Journal of Medicine, 2020.