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-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 July 27, 2036. 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	6
Patent Applications:	1,301
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

Constraining patent/regulatory exclusivity:

11,020,376

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 one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,020,376.

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

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/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 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

Hong Kong

Hungary

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

Slovenia

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
Argentina	105507	FORMA CRISTALINA DE BASE LIBRE DE LORLATINIB
Australia	2016304420	Crystalline form of lorlatinib free base
Brazil	112017028604	forma cristalina de base livre de lorlatinibe
Canada	2937257	FORME CRISTALLINE D'UNE BASE EXEMPTE DE LOLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE)
China	107849060	劳拉替尼游离碱的结晶形式 (Crystalline form of lorlatinib free base)

Supplementary Protection Certificates for LORBRENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	CA 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508
2822953	301006	Netherlands		PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953	2019C/539	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
2822953	122019000088	Germany		PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	LUC00131	Luxembourg		PRODUCT NAME: LORLATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508

Last updated: June 9, 2026

Lorbrena (lorlatinib) Market Dynamics and Financial Trajectory: Exclusivity, Patent/IP Risk, and Revenue Outlook

Lorbrena (lorlatinib) is an AstraZeneca kinase inhibitor with sales driven by first-line and subsequent-line adoption in ALK-positive metastatic non-small cell lung cancer (NSCLC), supported by durable clinical outcomes and expanding label breadth across lines of therapy. Near-term financial trajectory is shaped by (1) patent and regulatory exclusivity timing, (2) uptake in competitive ALK landscapes, (3) generic entry risk, and (4) payer behavior around high-cost oncology therapies.

What drives Lorbrena sales growth in ALK-positive NSCLC?

Which patient segments contribute most to revenue

Lorbrena’s revenue base concentrates in ALK-positive metastatic NSCLC, including:

• First-line metastatic disease (where Lorbrena has meaningful positioning versus earlier-generation ALK inhibitors).
• Post–ALK TKI progression settings, including patients with resistance after prior ALK inhibitors.
• Brain metastases cohorts, where lorlatinib’s CNS penetration translates into differentiated clinical adoption patterns versus agents with weaker intracranial activity.

How line-of-therapy affects adoption

Lorbrena monetization is highly sensitive to:

• Share capture in first-line use (higher volume, longer treatment exposure).
• Retention in later lines (driven by efficacy in refractory populations and physician familiarity).
• Sequencing dynamics as clinicians balance “front-loading” lorlatinib versus using earlier ALK inhibitors before switching.

Payer and hospital procurement dynamics

Key commercial constraints that typically shape oncology launch curves and plateau dynamics:

• Formulary positioning through prior authorization and step-therapy rules.
• Site-of-care pharmacy economics for high-cost oral oncology drugs.
• Net price pressure from contracting, rebates, and patient assistance programs, especially where multiple ALK options are formularized.

How strong is the Lorbrena patent estate versus generic entry risk?

What patents protect lorlatinib in the US

Lorbrena’s IP posture relies on a combination of:

• Active ingredient composition patents covering lorlatinib.
• Polymorph/crystal form and salt-related patents (where present in the portfolio).
• Formulation and dosage form patents (tablet/capsule embodiments and manufacturing controls).
• Method-of-use patents tied to ALK-positive NSCLC treatment regimens.

When does exclusivity end for Lorbrena?

Sales durability is driven by two layers:

• Patent expiration dates (composition, formulations, and method-of-use).
• FDA regulatory exclusivities (including patent term extensions where applicable and any data exclusivity tied to clinical submissions).

What generic entry risks exist for Lorbrena

Generic entry risk is dominated by:

• Whether ANDA filers can design around composition and method-of-use claims.
• Whether Paragraph IV certifications lead to litigation.
• Whether settlement agreements delay launch beyond the earliest patent expiry date.

Does Lorbrena face biosimilar risk or only generic small-molecule competition?

Lorbrena is a small-molecule targeted therapy (lorlatinib), so it does not face biosimilar pathways. Competitive risk comes from:

• Generic lorlatinib (ANDA) after patent and exclusivity barriers fall.
• “Authorized generics” and launch-day readiness by established generics.
• Potential class competition from other ALK inhibitors, including newer-generation agents or next-line CNS-optimized options that can pressure share without IP invalidation.

What is the Orange Book status of Lorbrena?

How to read Lorbrena Orange Book listings

Lorbrena’s Orange Book status typically maps to:

• Drug product and active ingredient entries.
• Patent codes (therapeutic equivalence and patent categories).
• Submission dates and expiration dates for each listed patent.

Which patent categories matter most for market exclusivity

• Composition of matter patents generally control the longest runway.
• Method-of-use patents can delay launch even where composition claims are challenged.
• Formulation/manufacturing patents can create additional design-around complexity.

Which companies compete with Lorbrena, and how does the ALK landscape impact revenue?

Primary ALK inhibitor competitors

Competitive pressure typically comes from:

• Other next-generation ALK TKIs (with strong intracranial efficacy) that contest first-line and post-progression patient share.
• Earlier-generation ALK TKIs that remain used in selected sequencing algorithms.

How competitive intensity changes Lorbrena pricing

In markets with multiple formularized ALK options:

• Net price erosion accelerates through tendering and contracting.
• Manufacturers trade rebates and access commitments for share preservation.
• Cost-effectiveness arguments become central for health technology assessment (HTA) bodies in major ex-US markets.

What patent litigation affects Lorbrena, including Paragraph IV and settlements?

How Paragraph IV strategy impacts launch timing

If Paragraph IV challenges target key patents:

• Filing triggers 30-month stay dynamics if litigation is initiated.
• Courts can narrow claims or uphold broad coverage depending on claim construction and prior art.
• Settlement can create “clock-stopping” delays that keep Lorbrena on market exclusivity longer than the earliest expiring listed patent.

Settlement-driven revenue protection

Settlement scenarios typically:

• Delay generic approval/launch date.
• Include licensing terms or non-infringement commitments.
• Create phased entry schedules by dosage strength or geography.

(Commercial impact is tied to whether the first generic arrives at the earliest allowed date or later due to litigation or settlement.)

How do first-line label strength and CNS data translate to financial trajectory?

Why CNS efficacy changes adoption

For ALK-positive NSCLC, intracranial disease is a high-frequency clinical need. Treatments with robust CNS activity:

• Convert “monitor then treat” brain metastasis pathways into earlier adoption.
• Increase durability when intracranial progression is a major discontinuation reason for other agents.

Impact on treatment duration

Longer time-on-treatment generally increases:

• Cumulative drug exposure per patient.
• The probability of sustained revenue if discontinuation rates stay low.

What is Lorbrena’s commercial trajectory by year, and what are the inflection points?

Launch-to-plateau mechanics

Lorbrena’s financial curve typically follows:

• Early growth driven by physician adoption and expanding indication coverage.
• Mid-period plateau where:
  • Patient identification stabilizes after biomarker testing maturity.
  • Competitive contracting begins to influence net revenue.
• Later dynamics driven by:
  • First-line share capture.
  • Market expansion into additional geographies.
  • Patent-driven risk perception shifting toward or away from generic threat.

Key inflection points to monitor

Revenue inflection is most sensitive to:

• FDA label expansions that widen eligible patients.
• Results from confirmatory trials that increase payor confidence.
• Patent events: expiry milestones, litigation outcomes, and settlement delays.
• Competitive launches that add alternative ALK options on formularies.

How do regulatory milestones and FDA pathway status affect timing and market access?

FDA approvals and line-of-therapy label updates

Financial trajectory is shaped by:

• Timing of approvals in successive treatment lines.
• New subpopulations (such as CNS disease emphasis) that expand prescriber eligibility.

US market access

US adoption depends on:

• Coverage determinations by major payers.
• Pharmacy benefit manager (PBM) contracting.
• Oncology drug access programs that can offset patient affordability barriers.

Non-US market access

Outside the US, revenue is driven by:

• National HTA decisions and reimbursement rates.
• Pricing frameworks and discounting norms.
• Tender procurement processes in countries with centralized purchasing.

How does Lorbrena compare with competing ALK inhibitors on market and IP resilience?

Share and durability comparison framework

Market resilience is usually determined by:

• Whether the drug is a preferred first-line regimen.
• Whether it holds intracranial efficacy superiority across resistance categories.
• Whether the patent estate includes multiple layers that raise generic “design-around” cost.
• Whether litigation historically supported longer exclusivity.

What to measure for financial trajectory

• Net sales trend versus category growth (ALK oncology).
• Prescribing shift from older TKIs.
• Payer formulary share across large managed care plans.
• Price and rebate changes as competitors gain or lose leverage.

What manufacturing and IP barriers could slow generic entry for lorlatinib?

Even after approvals, entry can be slowed by:

• Formulation-specific manufacturing controls.
• Patent claims covering dosage form and stability requirements.
• Supply chain readiness for oral oncology drugs.
• Complexities in bioequivalence where formulation or salt/crystal properties matter.

These barriers can extend “commercial exclusivity” beyond the legal milestone dates if generic readiness is delayed.

Key Takeaways

• Lorbrena’s revenue is driven by sustained adoption in ALK-positive metastatic NSCLC, with CNS efficacy acting as a key share catalyst.
• The financial trajectory depends on the combined effect of patent lifetimes, regulatory exclusivity, and any Paragraph IV litigation or settlements.
• Competitive intensity from other ALK inhibitors influences net price, formulary placement, and line-of-therapy sequencing.
• Biosimilar risk is not applicable; generic (ANDA) risk and class competition are the main disruptive forces.
• Near- and mid-term outlook is most sensitive to patent expiration cadence, litigation outcomes, and payer contracting dynamics.

FAQs

1. What is the most important driver of Lorbrena adoption in ALK-positive NSCLC?
2. Which patent categories typically determine the latest generic entry date for lorlatinib?
3. How do Paragraph IV challenges and 30-month stays change Lorbrena’s sales protection window?
4. Does Lorbrena’s CNS activity affect payer access and hospital formulary decisions?
5. What commercial signals indicate whether Lorbrena revenue will plateau or decline ahead of generic risk?

References

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

DrugChatter Q&A for LORBRENA

Is lorbrena available as a generic?
How does the cost of lorbrena compare to other similar medications?
Lorbrena generic alternatives alk positive nsclc?
Lorbrena generic alternatives alk positive nsclc?
How does lorbrena treat lung cancer?