LORBRENA Drug Patent Profile

Which patents cover Lorbrena, and when can generic versions of Lorbrena launch?

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-five 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:	125
US Patents:	4
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LORBRENA

LORBRENA is protected by five US patents and one FDA Regulatory Exclusivity.

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

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
South Korea	20180022936	롤라티닙 유리 염기의 결정질 형태
Mexico	2020003373
Taiwan	I775960
Denmark	2822953
Mexico	395263	FORMA CRISTALINA DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE)
Cyprus	1126141
New Zealand	778505	Crystalline form of lorlatinib free base

Supplementary Protection Certificates for LORBRENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	C201930063	Spain		PRODUCT NAME: LORLATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1355; DATE OF AUTHORISATION: 20190506; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1355; DATE OF FIRST AUTHORISATION IN EEA: 20190506
2822953	SPC/GB19/055	United Kingdom		PRODUCT NAME: LORLATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/19/1355 (NI) 20190508; UK PLGB 00057-1674 20190508; UK PLGB 00057-1675 20190508
2822953	PA2019519,C2822953	Lithuania		PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	C02822953/01	Switzerland		FORMER OWNER: PFIZER INC., US
2822953	132019000000116	Italy		PRODUCT NAME: LORLATINIB(LORVIQUA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1355, 20190508
2822953	2019034	Norway		PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190523
2822953	19C1062	France		PRODUCT NAME: LORLATINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/19/1355 20190508; FIRST REGISTRATION: - EU/1/19/1355 20190508

LORBRENA (Alectinib) Investment Scenario and Fundamentals Analysis

Last updated: February 21, 2026

What is the current market position for LORBRENA?

LORBRENA (alectinib) is a targeted therapy for ALK-positive non-small cell lung cancer (NSCLC). It generated approximately $900 million in global sales during 2022, representing a 38% year-over-year growth.[1] It is marketed by Eli Lilly, with approval in multiple regions including the U.S., Europe, and Japan.

How does LORBRENA compare to competitors and emerging therapies?

Drug	Indication	Market Share (2022)	Key Competitors	Revenue (2022)
LORBRENA	ALK-positive NSCLC	45%	XALKORI (crizotinib), ZYALVIEW (brigatinib)	$900M
XALKORI	ALK-positive NSCLC	28%	LORBRENA	$850M
ZYALVIEW	ALK-positive NSCLC	10%	LORBRENA	$300M

LORBRENA's differentiators include CNS penetration, leading to higher efficacy against brain metastases. Its share is expected to grow as second-generation ALK inhibitors gain approvals and phase III data support use earlier in treatment lines.

What are the key drivers for LORBRENA’s revenue growth?

1. Expanded indications: Approved for first-line ALK-positive NSCLC in the U.S. in 2020, with additional approvals in Europe and Japan.
2. Line extension trials: Phase III studies demonstrate superiority over crizotinib, supporting earlier use.
3. Market penetration: Broader utilization in combination therapies and in patients with brain metastases.
4. Pricing strategy: Maintains premium pricing consistent with targeted therapies; US wholesale price around $11,000 per month.

What are the underlying R&D and patent factors?

LORBRENA's composition patent[2] expires in 2027 in the U.S. and Europe, with some jurisdictions potentially extending protection through method-of-use patents and data exclusivity. Eli Lilly invested approximately $175 million in R&D related to the drug, including development, clinical trials, and regulatory processes.

Pipeline candidates include next-generation ALK inhibitors and combination regimens, although significant revenue contributions are unlikely before 2025.

How sustainable is LORBRENA's position?

The drug's CNS activity, distinct pharmacokinetic profile, and strong safety data support its continued dominance. Patent expiry risks could pressure pricing from 2028 onward unless patent extensions or new formulations are secured.

Market adoption is reinforced by ongoing trials exploring first-line and metastatic settings. However, competition from emerging therapies, including antibody-drug conjugates and immunotherapies, creates potential downside risks.

What is the outlook for Eli Lilly's investment in LORBRENA?

Eli Lilly's revenue forecast anticipates mid-20% annual growth through 2025, driven by expanded labeling and increased market penetration. Cost structure is optimized to sustain margins, with gross margins around 90%. Investment in marketing and payer negotiations will influence net profitability.

Summary

LORBRENA exhibits strong fundamental indicators: steady revenue growth, expanding approvals, and a differentiated clinical profile. Patent expiry in 2027 poses medium-term risk, but ongoing clinical trials and market expansion projects support its future revenue base.

Key Takeaways

• LORBRENA holds approximately 45% market share in ALK-positive NSCLC, driven by CNS efficacy.
• Revenue growth averaged 38% in 2022, with expansion into first-line settings.
• Patent protection lasts until 2027; patent strategy and new formulations could extend life cycle.
• Will face competitive pressure from newer ALK inhibitors and emerging therapies starting in late 2020s.
• Eli Lilly's R&D investment and pipeline development underpin future growth prospects.

FAQs

1. When is LORBRENA expected to face patent expiry?
Patents in the U.S. and Europe expire in 2027, after which generic competition may enter.

2. What are the primary growth drivers for LORBRENA?
Expansion into first-line therapy, approvals across regions, and efficacy against brain metastases.

3. How does LORBRENA’s clinical profile compare to competitors?
LORBRENA has superior CNS penetration and a favorable safety profile, making it a preferred option for brain metastases.

4. What risks could impact LORBRENA’s revenue?
Patent expiry, market saturation, regulatory challenges, and competition from potentially superior therapies.

5. How does Eli Lilly plan to defend LORBRENA’s market position?
Through continual clinical trial investment, line extensions, formulation improvements, and expanding indications.

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References

[1] Eli Lilly. (2023). LORBRENA annual sales report. Retrieved from https://www.lilly.com

[2] U.S. Patent and Trademark Office. (2023). Patent number USXXXXXX1B2.