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-one patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for LORLATINIB

International Patents:	121
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	34
Patent Applications:	102
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
SCRI Development Innovations, LLC	Phase 2
Guangdong Association of Clinical Trials	Phase 2
Guangdong Provincial People's Hospital	Phase 2

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	210868-002	Nov 2, 2018		RX	Yes	Yes	11,020,376		Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes	8,680,111		Y	Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No	11,299,500			Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes	11,299,500			Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No	8,680,111		Y	Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No	10,420,749		Y	Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes

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/004646 Lorviqua 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
Cyprus	2019033
New Zealand	627900	Macrocyclic derivatives for the treatment of proliferative diseases
Russian Federation	2020113141	КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРАТА СВОБОДНОГО ОСНОВАНИЯ ЛОРЛАТИНИБА
Poland	3694863
Argentina	090230	DERIVADOS MACROCICLICOS PARA EL TRATAMIENTO DE ENFERMEDADES
Serbia	55814	DERIVATI MAKROCIKLINA ZA TRETMAN PROLIFERATIVNIH BOLESTI (MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES)
Brazil	112017028604	forma cristalina de base livre de lorlatinibe

Supplementary Protection Certificates for LORLATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	PA2019519,C2822953	Lithuania		PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	2019034	Norway		PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190523
2822953	122019000088	Germany		PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	C20190036 00302	Estonia		PRODUCT NAME: LORLATINIIB;REG NO/DATE: EU/1/19/1355 08.05.2019
2822953	41/2019	Austria		PRODUCT NAME: LORLATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 (MITTEILUNG) 20190508
2822953	LUC00131	Luxembourg		PRODUCT NAME: LORLATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508
2822953	CA 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508

LORLATINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lorlatinib

Market Overview

Lorlatinib, marketed as Lorbrena, is a third-generation ALK inhibitor used primarily in the treatment of non-small cell lung cancer (NSCLC) with ALK mutations. The global market for lorlatinib is poised for significant growth, driven by several key factors.

Increasing Incidence of NSCLC with ALK Mutations

The rising incidence of NSCLC with ALK mutations is a primary driver of the lorlatinib market. As diagnostic techniques improve and awareness increases, more patients are being identified and treated for this specific type of cancer, leading to a higher demand for targeted therapies like lorlatinib[1].

Advances in Oncology Research

Advances in oncology research have led to better diagnosis and treatment options for patients with ALK-positive NSCLC. Lorlatinib's efficacy in treating this condition, particularly its ability to penetrate the central nervous system, makes it a preferred choice among healthcare providers[1].

Government Funding and Healthcare Infrastructure

Government funding and the development of healthcare infrastructure play crucial roles in the market growth of lorlatinib. In regions like North America, where there is a strong regulatory environment and significant research funding, the adoption of lorlatinib is higher due to quicker drug approvals and widespread availability[1].

Regional Market Analysis

North America

North America dominates the lorlatinib market, accounting for more than 47% of the global revenue. The high incidence of NSCLC, advanced healthcare infrastructure, and a strong regulatory environment in the U.S. and Canada drive this dominance. The U.S., in particular, has a favorable regulatory landscape that facilitates quicker drug approvals, enhancing the market presence and accessibility of lorlatinib[1].

Europe

Europe is another significant market for lorlatinib, with Western Europe experiencing higher adoption rates compared to Eastern Europe. The region's strong healthcare systems and high cancer rates contribute to the demand. However, varying healthcare policies and reimbursement practices across countries influence market growth[1].

Asia Pacific

The Asia Pacific region is seeing rapid growth in the lorlatinib market, driven by increasing cancer rates and expanding healthcare access, particularly in China and Japan. Regulatory approvals and local healthcare developments are critical factors, although affordability and distribution remain challenges in countries like India[1].

Financial Trajectory

Market Size and Growth

The global lorlatinib market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034, reaching a significant value by the end of the forecast period. The market size is estimated to increase substantially, driven by the factors mentioned above[1].

Cost-Effectiveness and Pricing

The cost-effectiveness of lorlatinib is a critical aspect of its financial trajectory. Studies have shown that while lorlatinib offers improved health outcomes, it is often not considered cost-effective compared to other ALK inhibitors like crizotinib at current prices. For example, at a willingness-to-pay (WTP) threshold of $200,000 per quality-adjusted life year (QALY), lorlatinib would need to be priced at around $424.50 to be considered cost-effective[2].

Incremental Cost-Effectiveness Ratio (ICER)

The ICER for lorlatinib compared to other treatments is a key financial metric. According to various analyses, the ICER for lorlatinib compared to crizotinib or brigatinib is typically high, ranging from $128,964 to $147,368 per QALY. This indicates that lorlatinib is not cost-effective at standard WTP thresholds without a significant price reduction[4].

Distribution Channels

The distribution of lorlatinib through various channels, including hospitals, retail pharmacies, and online pharmacies, also impacts its financial trajectory. Hospital pharmacies are a major distribution channel, given the nature of the treatment and the need for close medical supervision[1].

Key Market Players

Pfizer Inc. is the primary player in the lorlatinib market, given its role in developing and marketing Lorbrena. The company's strong presence in the pharmaceutical industry and its ability to navigate regulatory environments effectively contribute to the drug's market dominance[1].

Market Segmentation

By Indication

Lorlatinib is primarily used for the treatment of NSCLC with ALK mutations. The market is segmented based on this indication, with NSCLC being the main driver of revenue. Other cancers may also be treated with lorlatinib, but NSCLC remains the core focus[1].

By Distribution Channel

The market is segmented into hospitals, retail pharmacies, and online pharmacies. Hospitals are the primary distribution channel due to the need for specialized care and monitoring associated with cancer treatment[1].

By Region

The global lorlatinib market is segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South America. Each region has its unique market dynamics, influenced by local healthcare systems, regulatory environments, and economic conditions[1].

Future Outlook

Clinical Trials and Pipeline

Ongoing clinical trials and a robust pipeline of related medications are expected to enhance the commercial potential of lorlatinib. These trials aim to explore new indications and improve treatment outcomes, which could further solidify lorlatinib's position in the market[1].

Regulatory Approvals

Regulatory approvals in various regions will continue to play a crucial role in the market growth of lorlatinib. Favorable regulatory environments, such as those in North America, will facilitate quicker approvals and wider availability of the drug[1].

Financial Support and Infrastructure

Improved patient access through financial support and improved infrastructure will also contribute to market growth. Governments and healthcare organizations are increasingly providing financial support to make advanced therapies like lorlatinib more accessible to patients[1].

Cost-Effectiveness Considerations

Price Adjustments

For lorlatinib to be considered cost-effective, significant price adjustments may be necessary. Studies suggest that a price reduction of at least 42% would be required to make lorlatinib an optimal treatment option at a WTP threshold of $50,000 per QALY[4].

Scenario Analyses

Scenario analyses have shown that adjusting the price of lorlatinib can greatly impact its cost-effectiveness. For instance, reducing the price to 75% of its original cost can make lorlatinib 100% cost-effective at a WTP threshold of $200,000/QALY compared to crizotinib[2].

Key Takeaways

• Market Growth: The lorlatinib market is expected to grow significantly due to increasing incidences of NSCLC with ALK mutations and advances in oncology research.
• Regional Dominance: North America leads the market, followed by Europe and the Asia Pacific region.
• Cost-Effectiveness: Lorlatinib is often not cost-effective at current prices but can become so with significant price reductions.
• Distribution Channels: Hospitals are the primary distribution channel for lorlatinib.
• Future Outlook: Ongoing clinical trials, regulatory approvals, and financial support will drive market growth.

FAQs

What is the primary indication for lorlatinib?

Lorlatinib is primarily used for the treatment of non-small cell lung cancer (NSCLC) with ALK mutations.

Which region dominates the lorlatinib market?

North America dominates the lorlatinib market, accounting for more than 47% of the global revenue.

Is lorlatinib cost-effective at current prices?

Lorlatinib is often not considered cost-effective at current prices compared to other ALK inhibitors like crizotinib, but it can become cost-effective with significant price reductions.

What are the main distribution channels for lorlatinib?

The main distribution channels for lorlatinib include hospitals, retail pharmacies, and online pharmacies, with hospitals being the primary channel.

What factors drive the market growth of lorlatinib?

The market growth of lorlatinib is driven by increasing incidences of NSCLC with ALK mutations, advances in oncology research, government funding, and improved healthcare infrastructure.

Sources

1. We Market Research: Lorlatinib Market Size, Share & Global Industry Trends 2034.
2. Frontiers in Oncology: Cost-Effectiveness of Lorlatinib as a First-Line Therapy for Untreated ALK+ NSCLC.
3. GlobeNewswire: Global Cancer ALK Inhibitor Market is estimated to be US$ 10.6 billion by 2030.
4. NCBI Bookshelf: Pharmacoeconomic Review - Lorlatinib (Lorbrena).