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LORBRENA Drug Patent Profile

When do Lorbrena patents expire, and what generic alternatives are available?

Lorbrena is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and twenty-one patent family members in fifty countries.

The generic ingredient in LORBRENA is lorlatinib. Two suppliers are listed for this compound. Additional details are available on the lorlatinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Lorbrena

Lorbrena was eligible for patent challenges on November 2, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LORBRENA

International Patents:	121
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	6
Patent Applications:	221
Drug Prices:	Drug price information for LORBRENA
What excipients (inactive ingredients) are in LORBRENA?	LORBRENA excipients list
DailyMed Link:	LORBRENA at DailyMed

See drug prices for LORBRENA

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

NDA:

210868

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 LORBRENA

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

Sponsor	Phase
SCRI Development Innovations, LLC	Phase 2
Pfizer	Phase 2
Guangdong Association of Clinical Trials	Phase 2

See all LORBRENA clinical trials

Pharmacology for LORBRENA

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

US Patents and Regulatory Information for LORBRENA

LORBRENA is protected by five US patents and five FDA Regulatory Exclusivities.

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
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No			Y	Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No				Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes

EU/EMA Drug Approvals for LORBRENA

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 LORBRENA

When does loss-of-exclusivity occur for LORBRENA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Mexico

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 LORBRENA around the world.

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

Supplementary Protection Certificates for LORBRENA

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

LORBRENA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lorbrena

Introduction

Lorbrena, a lung cancer drug developed by Pfizer, has been making significant waves in the pharmaceutical industry with its promising clinical trial results and ambitious sales targets. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Clinical Trial Results and Efficacy

Lorbrena has shown remarkable efficacy in clinical trials, particularly in the Phase 3 CROWN trial presented at the American Society of Clinical Oncology meeting. The drug demonstrated a 60% progression-free survival rate after five years for ALK-positive advanced lung cancer patients, and 53% for those with brain metastases. This is a stark contrast to Pfizer's older medication, Xalkori, which had a mere 8% five-year progression-free survival rate[1][4].

Market Potential

Given its impressive clinical outcomes, Lorbrena is poised to become a blockbuster drug. Pfizer's Chief Oncology Officer, Chris Boshoff, highlighted the drug's potential due to increased uptake, market penetration, and longer treatment durations. The market in China is particularly promising, where up to 7% of non-small cell lung cancer (NSCLC) patients are ALK-positive, compared to 4% globally[1][4].

Sales Projections

Lorbrena is expected to generate over $1 billion in annual sales by 2030. In the first quarter of 2024, the drug already showed a 46% year-over-year increase, bringing in $164 million. This growth is crucial for Pfizer as it faces declining revenues from its COVID-19 products like Comirnaty and Paxlovid[1][4].

Financial Impact on Pfizer

The success of Lorbrena is part of Pfizer's broader strategy to offset the decline in COVID-19 product revenues. Pfizer aims to have at least eight blockbuster cancer drugs by 2030, up from its current five. This aggressive target is aligned with the company's pivot towards cancer treatments, ensuring long-term growth and maintaining its dominance in the pharmaceutical industry[1][3].

Cost Realignment and Efficiency Measures

To support the growth of drugs like Lorbrena, Pfizer has initiated a cost realignment program aimed at reducing overall R&D and Selling, Informational, and Administrative (SI&A) expenses by an estimated $4 billion annually. Half of these savings have already been realized, with the rest expected to be achieved in 2024. Additionally, Pfizer has launched a Manufacturing Optimization Program anticipated to save approximately $1.5 billion by the end of 2027[2][5].

Revenue Growth and Guidance

Excluding contributions from Comirnaty and Paxlovid, Pfizer's revenues grew 14% operationally in the second quarter of 2024 compared to the prior-year quarter. The company has raised its full-year 2024 revenue guidance to a range of $59.5 to $62.5 billion and adjusted diluted EPS guidance to a range of $2.45 to $2.65. This growth is driven by focused commercial execution and the performance of acquired and in-line products[5].

Competitive Landscape

Lorbrena's success also reflects Pfizer's strategic acquisitions, such as the $43 billion acquisition of cancer drugmaker Seagen. This acquisition is expected to immediately increase top-line growth and position Pfizer as a leader in genitourinary and bladder cancers. Seagen's pipeline is projected to add $10 billion in revenue by 2030, further bolstering Pfizer's oncology portfolio[3].

Regional Focus

China is a key market for Lorbrena due to the higher prevalence of ALK-positive NSCLC patients. Pfizer's strategic focus on this region is expected to drive significant sales growth for the drug. The company's ability to penetrate this market effectively will be crucial in achieving its sales targets[1][4].

Patient Longevity and Treatment Duration

Many patients in Pfizer's clinical trials have been on Lorbrena for more than five years, compared to the median progression-free survival of 10 to 11 months for Xalkori. This extended treatment duration not only improves patient outcomes but also increases the revenue potential for the drug[4].

Risks and Challenges

While Lorbrena shows great promise, there are risks associated with its success. There is no guarantee that pipeline drugs will pass clinical trials, receive approval, or generate significant sales. Additionally, regulatory changes, such as the Inflation Reduction Act, could impact drug prices and revenues if Pfizer is included in future price negotiations[3].

Conclusion

Lorbrena is poised to be a game-changer in the treatment of ALK-positive advanced lung cancer, with its impressive clinical trial results and strong market potential. Pfizer's strategic focus on this drug, along with its cost realignment and efficiency measures, positions the company for long-term growth in the oncology sector.

Key Takeaways

• Clinical Efficacy: Lorbrena demonstrated a 60% progression-free survival rate after five years for ALK-positive advanced lung cancer patients.
• Sales Projections: Expected to generate over $1 billion in annual sales by 2030.
• Market Focus: Strategic focus on China due to higher prevalence of ALK-positive NSCLC patients.
• Financial Impact: Part of Pfizer's strategy to offset declining COVID-19 product revenues.
• Cost Efficiency: Supported by Pfizer's cost realignment program and manufacturing optimization.
• Competitive Advantage: Bolstered by the acquisition of Seagen and its robust pipeline.

FAQs

Q: What are the key clinical trial results for Lorbrena? A: Lorbrena showed a 60% progression-free survival rate after five years for ALK-positive advanced lung cancer patients and 53% for those with brain metastases[1][4].

Q: How much is Lorbrena expected to generate in annual sales by 2030? A: Lorbrena is expected to generate over $1 billion in annual sales by 2030[1][4].

Q: Why is China an important market for Lorbrena? A: China has a higher prevalence of ALK-positive NSCLC patients, with up to 7% compared to 4% globally[1][4].

Q: How does Lorbrena fit into Pfizer's overall strategy? A: Lorbrena is part of Pfizer's strategy to pivot towards cancer treatments and offset declining COVID-19 product revenues[1][3].

Q: What are the potential risks associated with Lorbrena's success? A: Risks include the uncertainty of pipeline drugs passing clinical trials and receiving approval, as well as potential regulatory impacts on drug prices[3].