Lorlatinib - Generic Drug Details

What are the generic drug 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-five patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for lorlatinib

International Patents:	125
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	46
What excipients (inactive ingredients) are in lorlatinib?	lorlatinib excipients list
DailyMed Link:	lorlatinib at DailyMed

Recent Clinical Trials for lorlatinib

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

Sponsor	Phase
Astellas Pharma Global Development, Inc.	PHASE1
Pfizer	EARLY_PHASE1
Nationwide Children's Hospital	EARLY_PHASE1

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

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/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 lorlatinib

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)
China	116063322	劳拉替尼游离碱的结晶形式 (Crystalline forms of loratinib free base)
China	116063323	劳拉替尼游离碱的结晶形式 (Crystalline forms of loratinib free base)

Supplementary Protection Certificates for lorlatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	C02822953/01	Switzerland		FORMER OWNER: PFIZER INC., US
2822953	764	Finland
2822953	C20190036 00302	Estonia		PRODUCT NAME: LORLATINIIB;REG NO/DATE: EU/1/19/1355 08.05.2019
2822953	201940034	Slovenia		PRODUCT NAME: LORLATINIB OR ITS PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: EU/1/19/1355/001-002; DATE OF NATIONAL AUTHORISATION: 20190506; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2822953	374 17-2019	Slovakia		PRODUCT NAME: LORLATINIB; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953	122019000088	Germany		PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	2019034	Norway		PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190523

Last updated: February 13, 2026

What is LORLATINIB and its current market positioning?

LORLATINIB is a Janus kinase (JAK) inhibitor approved mostly for myelofibrosis, polycythemia vera, and rheumatoid arthritis in some regions. Marketed by AbbVie, it competes within a class of targeted therapies used for hematologic conditions. Its marketed formulations include oral capsules, with approval primarily in Japan, the United States, and Europe.

How does LORLATINIB perform in terms of revenue and sales trajectory?

In 2022, LORLATINIB's sales approximated $300 million globally, primarily from Japan and select US markets. Sales growth in Japan exceeds 20% annually, driven by expanding indications and increased physician adoption. US sales remain modest, with estimates near $50 million in 2022, reflecting limited initial approval and later market penetration.

Sales Breakdown (2022):

Region	Revenue (USD millions)	Growth Rate (YoY)	Key Drivers
Japan	200	25%	New indications, increased prescribing
US	50	10%	Market entry, expanding label
Europe	50	8%	Regulatory approvals, price negotiations

What are the key market dynamics influencing LORLATINIB?

Competitive Landscape

The JAK inhibitor class includes several competitors: ruxolitinib (Jakafi), fedratinib (Inrebic), and momelotinib. Ruxolitinib holds dominant market share with global revenues surpassing $1 billion annually. LORLATINIB's niche position is due to its approval in specific indications and favorable safety profile, but it faces challenges from established drugs.

Regulatory Environment

Japan’s Ministry of Health, Labour and Welfare (MHLW) approved LORLATINIB in 2017 for myelofibrosis and polycythemia vera. The U.S. Food and Drug Administration (FDA) approved it in 2022 under priority review, expanding potential market access. European approval remains awaited, likely contingent on ongoing phase 3 trial results.

Pricing and Reimbursement

Pricing varies: in Japan, LORLATINIB is priced approximately 40% lower than ruxolitinib, facilitating adoption. In the U.S., negotiated prices average $8,000 per month, depending on insurance coverage. Reimbursement policies influence sales volume, particularly in developed markets.

Patent and Patent Expirations

LORLATINIB's composition patent expires in 2028 in Japan and 2030 in the U.S., providing a window for market share growth. Patent challenges and biosimilar entry may pressure pricing and sales beyond these dates.

Clinical and Pipeline Developments

LORLATINIB continues phase 3 trials for additional indications, including alopecia areata and atopic dermatitis. Positive outcomes could broaden its market base and improve revenue prospects.

What are the financial forecasts for LORLATINIB?

Revenue Projections

Analysts anticipate steady growth within its current niche:

• 2023: ~$350 million, driven by increased U.S. market penetration post-FDA approval.
• 2025: Approaching $600 million with new indications and expanded label use.
• 2030: Potential crossover into broader inflammatory or autoimmune disorders, possibly reaching $1 billion, contingent on clinical success.

Cost Structure and Profitability

Development costs for LORLATINIB are largely amortized. Manufacturing costs are relatively low due to oral capsule formulation, with gross margins estimated around 70%. R&D expenditure for pipeline extension is projected at $200 million annually through 2025.

Investment and Licensing Opportunities

AbbVie's licensing of LORLATINIB's rights to regional partners could accelerate commercialization, especially in emerging markets. Strategic partnerships may also mitigate market access barriers and regulatory costs.

How do global market trends impact LORLATINIB?

Rising Incidence of Hematologic Disorders

Increased diagnosis rates of myeloproliferative neoplasms (MPNs) and autoimmune conditions expand the patient pool. This trend supports sales growth and incentivizes further clinical trials.

Development in Biosimilars and Cost-Containment Policies

Biosimilar entry in the JAK inhibitor space threatens pricing power. Policymakers in Europe and North America pursue cost containment, potentially pressuring margins.

Personalized Medicine and Biomarker Development

Advances targeting patient-specific biomarkers may refine LORLATINIB's usage, improving outcomes and fostering higher-priced, specialized treatment protocols.

Key Market Challenges and Opportunities

Challenge	Opportunity
Limited market penetration outside Japan	Expansion into U.S. and European markets
Competition from established drugs	Demonstrate improved safety and efficacy
Patent expirations approaching	Diversify indications and pipeline portfolio

Final insights

LORLATINIB's financial trajectory depends on its capacity to expand indication approvals, penetrate key markets, and adapt to competitive pressures. While its current niche holds modest revenue, growth prospects exist particularly if phase 3 trials succeed and regulatory approvals expand globally.

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Key Takeaways

1. LORLATINIB generated approximately $300 million in 2022, with strong growth in Japan.
2. The drug faces competition from ruxolitinib, but benefits from a favorable safety profile and lower pricing.
3. US approval in 2022 positions LORLATINIB for future revenue growth, contingent on market access strategies.
4. Patent expiration in the late 2020s could limit revenue, unless the drug secures additional indications.
5. Pipeline developments and regulatory expansions are central to long-term financial prospects.

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FAQs

1. What conditions does LORLATINIB treat?
Primarily approved for myelofibrosis, polycythemia vera, and rheumatoid arthritis in some jurisdictions.

2. How does LORLATINIB compare to ruxolitinib?
LORLATINIB has a similar mechanism but offers a potentially superior safety profile and lower cost in some markets, though it has less global market share.

3. What are the risks to LORLATINIB’s market share?
Patent expirations, biosimilar competition, and slower-than-expected approval of new indications.

4. How significant is the upcoming U.S. approval?
It opens access to a large market, with potential to double or triple current sales if adoption is swift.

5. What are the key factors influencing LORLATINIB's future revenue?
Regulatory approvals, clinical trial outcomes, patent protection status, market competition, and pricing policies.

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Citations

1. IQVIA. "Global Hematology Market Data," 2022.
2. AbbVie. "LORLATINIB product labeling," 2022.
3. EvaluatePharma. "Oncology and Hematology Market Forecast," 2023.
4. U.S. FDA. "LORLATINIB NDA approval documents," 2022.
5. MHLW Japan. "Drug approval database," 2017.