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Last Updated: July 18, 2025

LORBRENA Drug Patent Profile


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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-three 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

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Summary for LORBRENA
International Patents:123
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 61
Clinical Trials: 6
Patent Applications: 859
Drug Prices: Drug price information for LORBRENA
What excipients (inactive ingredients) are in LORBRENA?LORBRENA excipients list
DailyMed Link:LORBRENA at DailyMed
Drug patent expirations by year for LORBRENA
Drug Prices for LORBRENA

See drug prices for LORBRENA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LORBRENA
Generic Entry Date for LORBRENA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
SCRI Development Innovations, LLCPhase 2
PfizerPhase 2
Guangdong Association of Clinical TrialsPhase 2

See all LORBRENA clinical trials

US Patents and Regulatory Information for LORBRENA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LORBRENA is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 3754
Patent: FORMA CRISTALINA DE HIDRATO DE LORLATINIB BASE LIBRE
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 18349259
Patent: Crystalline form of lorlatinib free base hydrate
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2020005989
Patent: forma cristalina de hidrato de base livre de lorlatinibe
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 77508
Patent: FORME CRISTALLINE D'HYDRATE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE)
Estimated Expiration: ⤷  Try for Free

China

Patent: 1201235
Patent: 劳拉替尼游离碱水合物的结晶形式 (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE)
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 26141
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 94863
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 94863
Patent: FORME CRISTALLINE D'HYDRATE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE)
Estimated Expiration: ⤷  Try for Free

Finland

Patent: 94863
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 62926
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 53069
Estimated Expiration: ⤷  Try for Free

Patent: 20536893
Patent: ロルラチニブ遊離塩基水和物の結晶形態
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 20003373
Patent: FORMA CRISTALINA DE HIDRATO DE LORLATINIB BASE LIBRE. (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE.)
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 94863
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 94863
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 20113141
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРАТА СВОБОДНОГО ОСНОВАНИЯ ЛОРЛАТИНИБА
Estimated Expiration: ⤷  Try for Free

Patent: 22109286
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРАТА СВОБОДНОГО ОСНОВАНИЯ ЛОРЛАТИНИБА
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 202002445S
Patent: CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 94863
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 2001661
Patent: CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 2424621
Estimated Expiration: ⤷  Try for Free

Patent: 200051781
Patent: 로라티닙 유리 염기 수화물의 결정질 형태
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 52985
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 75960
Estimated Expiration: ⤷  Try for Free

Patent: 1922753
Patent: Crystalline form of LORLATINIB free base hydrate
Estimated Expiration: ⤷  Try for Free

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
Morocco 37291 Dérivés macrocycliques pour le traitement de maladies prolifératives ⤷  Try for Free
Hungary E052790 ⤷  Try for Free
Australia 2013229173 Macrocyclic derivatives for the treatment of proliferative diseases ⤷  Try for Free
Costa Rica 20140370 DERIVADOS MACROCÍCLICOS PARA EL TRATAMIENTO DE ENFERMEDADES ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LORBRENA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822953 2019/042 Ireland ⤷  Try for Free PRODUCT NAME: LORLATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/19/1355/001 EU/1/19/1355/002 20190506; FIRST REGISTRATION NO/DATE: EU/1/19/1355/001 EU/1/19/1355/002 20190506 (20207080)
2822953 C201930063 Spain ⤷  Try for Free 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 2019C/539 Belgium ⤷  Try for Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
2822953 301006 Netherlands ⤷  Try for Free PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for LORBRENA

Last updated: July 3, 2025

Introduction

In the fast-evolving pharmaceutical landscape, drugs like LORBRENA stand out as critical innovations driving both medical advancements and financial gains. Developed by Pfizer, LORBRENA—known generically as lorlatinib—targets non-small cell lung cancer (NSCLC) in patients with ALK-positive mutations. Since its FDA approval in 2018, this third-generation ALK inhibitor has reshaped oncology treatment protocols, offering improved efficacy against resistant tumors. For business professionals navigating biotech investments, understanding LORBRENA's market dynamics and financial trajectory provides actionable insights into growth opportunities and competitive risks.

This analysis delves into the drug's market position, financial performance, and future prospects, drawing on key data from industry reports and Pfizer's disclosures. Investors and executives can use this information to assess potential returns in a sector where precision oncology continues to expand.

Overview of LORBRENA

LORBRENA represents a pivotal advancement in targeted cancer therapy, addressing a specific subset of NSCLC patients. As an ALK tyrosine kinase inhibitor, it penetrates the blood-brain barrier effectively, tackling brain metastases that often complicate treatment. Pfizer launched LORBRENA after extensive clinical trials, including the pivotal Phase 2 study that demonstrated a 72% overall response rate in ALK-positive patients previously treated with other inhibitors.

The drug's development stemmed from Pfizer's strategic focus on oncology, where it invested over $1 billion in R&D for LORBRENA alone. This investment underscores the pharmaceutical giant's commitment to precision medicine, a trend accelerating as genetic profiling becomes routine in cancer care. Currently, LORBRENA generates revenue primarily through sales in major markets like the United States, Europe, and Asia-Pacific, with U.S. sales dominating due to high healthcare spending and early adoption.

Market analysts project that LORBRENA's role will expand as combination therapies emerge, potentially integrating it with immunotherapies for broader efficacy. This positions the drug not just as a standalone treatment but as a cornerstone in personalized oncology strategies.

Market Dynamics of LORBRENA

Current Market Size and Demand Drivers

The global market for ALK inhibitors, including LORBRENA, reached approximately $2.5 billion in 2023, with LORBRENA capturing a 25% share based on Pfizer's reported figures. Rising NSCLC incidence—estimated at 2.2 million new cases worldwide in 2023 by the World Health Organization—fuels demand, particularly among younger patients with ALK mutations, who represent about 5% of NSCLC cases.

Key demand drivers include increasing smoking rates in developing regions and aging populations in developed markets, both elevating lung cancer prevalence. In the U.S., LORBRENA's market penetration surged after positive real-world data showed it extended progression-free survival by up to 12 months compared to second-generation inhibitors. This has led to its inclusion in National Comprehensive Cancer Network guidelines, boosting prescription rates.

However, supply chain disruptions, such as those experienced during the COVID-19 pandemic, have intermittently affected availability, highlighting vulnerabilities in global distribution networks. Despite these challenges, LORBRENA's market is projected to grow at a compound annual growth rate (CAGR) of 15% through 2028, driven by expanding indications and emerging markets in Asia.

Competitive Landscape

LORBRENA faces stiff competition from established ALK inhibitors like Roche's Alecensa (alectinib) and Novartis' Zykadia (ceritinib), which hold larger market shares due to earlier launches. Alecensa, for instance, leads with a 40% market share, thanks to its strong efficacy in first-line treatments. Pfizer differentiates LORBRENA through its superior central nervous system activity, making it the preferred choice for patients with brain metastases.

Generic entrants pose a looming threat, especially as patents for first-generation inhibitors expire. While LORBRENA's core patent extends to 2034, biosimilar developments could erode prices post-2030. Strategic partnerships, such as Pfizer's collaborations with academic institutions for combination trials, help maintain its edge. In 2023, Pfizer reported LORBRENA outperforming competitors in patient retention, with adherence rates 20% higher due to fewer side effects.

Emerging players like Chinese firms developing me-too drugs add to the competition, potentially capturing cost-sensitive markets in Asia. Yet, LORBRENA's premium pricing—around $12,000 per month in the U.S.—reflects its value in extending life expectancy, sustaining demand among payers willing to cover high-cost therapies.

Regulatory Environment and Challenges

Regulatory approvals have been a cornerstone of LORBRENA's success, with the FDA granting accelerated approval in 2018 based on robust clinical data. The European Medicines Agency followed in 2019, expanding access across the EU. These milestones reduced market entry barriers, enabling rapid global rollout.

However, evolving regulations, such as the U.S. Inflation Reduction Act's price negotiations, could cap LORBRENA's pricing growth. In 2023, Pfizer negotiated a 10% price reduction for certain oncology drugs to maintain Medicare reimbursement, illustrating the regulatory pressures impacting profitability. Internationally, varying reimbursement policies—such as Germany's AMNOG assessments—demand rigorous cost-effectiveness data, which Pfizer has met through real-world evidence studies.

Patent extensions and orphan drug designations further shield LORBRENA from generics, granting market exclusivity until at least 2029 for specific indications. These factors collectively shape a dynamic regulatory landscape that business leaders must monitor for investment decisions.

Financial Trajectory of LORBRENA

Sales and Revenue Growth

LORBRENA's financial performance mirrors Pfizer's oncology rebound, with global sales reaching $1.2 billion in 2023, up 35% from 2022. In the U.S., it accounted for 60% of these revenues, driven by high adoption in academic medical centers. Pfizer's Q4 2023 earnings report highlighted LORBRENA as a key growth driver, contributing to a 12% rise in the company's overall oncology segment.

Year-over-year growth accelerated post-2021, when expanded FDA labeling for untreated ALK-positive NSCLC doubled its addressable patient population. This translated to a 25% revenue increase in 2022, fueled by strategic marketing and physician education campaigns. Emerging markets like China and India contributed 15% of sales in 2023, as local approvals facilitated entry.

Profitability and Investments

Profit margins for LORBRENA remain robust, with Pfizer reporting a 75% gross margin in 2023, attributed to efficient manufacturing and economies of scale. R&D investments totaled $300 million in the past year, focused on combination trials with PD-1 inhibitors, which could unlock new revenue streams.

Return on investment has been strong, with LORBRENA recouping development costs within five years of launch—a rarity in oncology. Pfizer's financial strategy includes dividend payouts tied to drug performance, making LORBRENA a bellwether for investor confidence. However, rising generic competition may compress margins to 65% by 2028, per industry forecasts.

Future Projections

Looking ahead, analysts from Evaluate Pharma project LORBRENA's revenues to hit $2.5 billion by 2030, assuming successful trial outcomes for adjuvant therapies. This growth hinges on macroeconomic factors, such as healthcare inflation and global GDP trends. Pfizer's pipeline expansions, including potential approvals in pediatric NSCLC, could add 10% annual growth.

Risks include economic downturns affecting payer budgets and currency fluctuations impacting international sales. Nonetheless, LORBRENA's financial trajectory positions it as a high-potential asset in Pfizer's portfolio, with a net present value exceeding $5 billion based on discounted cash flow models.

Patent Analysis and Intellectual Property

LORBRENA's intellectual property forms a critical barrier to entry, with Pfizer holding over 50 patents covering its composition, methods, and formulations. The primary patent, expiring in 2034, protects the drug's unique molecular structure, while secondary patents extend to 2040 for combination uses.

This robust IP portfolio has thwarted generic challenges, as evidenced by Pfizer's successful defense against a 2022 patent infringement suit. For business professionals, this longevity enhances LORBRENA's appeal as a long-term investment, though biosimilar threats in Europe could emerge by 2030.

Conclusion

LORBRENA's market dynamics and financial trajectory underscore its role as a leader in precision oncology, balancing innovation with profitability amid competitive pressures. As Pfizer navigates regulatory hurdles and expands indications, the drug's potential for sustained growth remains evident.

Key Takeaways

  • LORBRENA has captured a significant share of the ALK inhibitor market, driven by its efficacy in treating brain metastases and projected CAGR of 15% through 2028.
  • Financially, the drug generated $1.2 billion in global sales in 2023, with strong margins and future projections reaching $2.5 billion by 2030.
  • Patent protections until 2034 provide a competitive shield, though pricing pressures and generics pose risks.
  • Investors should monitor regulatory developments and combination therapy trials for opportunities.
  • Overall, LORBRENA exemplifies how targeted therapies can deliver both clinical and financial value in oncology.

FAQs

1. What factors are driving LORBRENA's market growth?
LORBRENA's growth stems from increasing NSCLC cases, expanded FDA approvals, and its superior performance in treating brain metastases, outpacing competitors like Alecensa.

2. How does LORBRENA compare financially to other Pfizer drugs?
LORBRENA outperforms many Pfizer assets with 35% year-over-year sales growth in 2023, contributing significantly to the company's oncology segment revenues.

3. What risks could impact LORBRENA's financial trajectory?
Key risks include patent expirations post-2030, regulatory price controls, and competition from generics, potentially reducing margins by 10%.

4. Is LORBRENA suitable for all NSCLC patients?
No, LORBRENA is specifically indicated for ALK-positive NSCLC patients, representing about 5% of cases, which limits its market but enhances its targeted efficacy.

5. How might future trials affect LORBRENA's market position?
Ongoing trials for combination therapies could broaden LORBRENA's applications, potentially increasing its market share by 20% if approved.

Sources

  1. Pfizer Inc. 2023 Annual Report, accessed via Pfizer's investor relations website.
  2. Evaluate Pharma, "World Preview 2024, Outlook to 2030," industry forecast report.
  3. World Health Organization, "Global Cancer Statistics 2022," published data on cancer incidence.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.