Neratinib maleate - Generic Drug Details

What are the generic sources for neratinib maleate and what is the scope of freedom to operate?

Neratinib maleate is the generic ingredient in one branded drug marketed by Puma Biotech and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Neratinib maleate has two hundred and nine patent family members in thirty-five countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for neratinib maleate

International Patents:	209
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for neratinib maleate
DailyMed Link:	neratinib maleate at DailyMed

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

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 neratinib maleate

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
National Cancer Institute (NCI)	Phase 1
Korea University Guro Hospital	Phase 2

See all neratinib maleate clinical trials

Generic filers with tentative approvals for NERATINIB MALEATE

Applicant	Application No.	Strength	Dosage Form
		40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for neratinib maleate

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for neratinib maleate

L01EH	Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for NERATINIB MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NERLYNX	Tablets	neratinib maleate	40 mg	208051	1	2021-07-19

US Patents and Regulatory Information for neratinib maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y	Y
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes

Expired US Patents for neratinib maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017

International Patents for neratinib maleate

Country	Patent Number	Title	Estimated Expiration
Spain	2586435
South Korea	20180041753	-2-부텐아미드의 말레에이트 염 및 이의 결정질 형태 (--4-3--4-2--3--7--6--4--2- MALEATE SALTS OF E-N-4-[3-CHLORO-4-2-PYRIDINYLMETHOXYANILINO]-3-CYANO-7-ETHOXY-6-QUINOLINYL-4-DIMETHYLAMINO-2-BUTENAMIDE AND CRYSTALLINE FORMS THEREOF)
South Korea	20130025862	MALEATE SALTS OF (E)-N-{4-[3-CHLORO-4-(2-PYRIDINYLMETHOXY)ANILINO]-3-CYANO-7-ETHOXY-6-QUINOLINYL}-4-(DIMETHYLAMINO)-2-BUTENAMIDE AND CRYSTALLINE FORMS THEREOF

Supplementary Protection Certificates for neratinib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3000467	23C1027	France		PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180904
4066821	C20250029	Finland
3000467	2390021-0	Sweden		PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904

Market Dynamics and Financial Trajectory for NERATINIB MALEATE

Last updated: July 28, 2025

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Introduction

Neratinib maleate, marketed under the brand name Nerlynx® (by Puma Biotechnology), is an oral tyrosine kinase inhibitor targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). Approved primarily for adjuvant treatment in HER2-positive early-stage breast cancer, neratinib has garnered attention for its potential in expanding indications within oncology. Analyzing the market dynamics and financial trajectory of neratinib maleate involves understanding its regulatory history, competitive landscape, commercialization strategy, and evolving market demand.

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Regulatory and Clinical Development Landscape

Regulatory Milestones:
Neratinib received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2017 for extended adjuvant treatment of adult patients with HER2-positive early invasive breast cancer for up to one year following trastuzumab-based therapy (FDA, 2017)[1]. Subsequently, regulatory agencies in Europe and other regions have initiated review processes, though approval timelines vary globally.

Clinical Data and Indications:
The NALA trial established neratinib's efficacy in HER2-positive metastatic breast cancer resistant to prior therapies, demonstrating progression-free survival benefits (Naional Cancer Database, 2020)[2]. The drug's adverse event profile, notably diarrhea, necessitates management strategies, influencing its adoption.

Pipeline Opportunities:
Beyond breast cancer, preclinical and early-phase studies explore neratinib’s utility against other HER2-expressing tumors, including gastric and colorectal cancers. Such expansion could elevate demand, but clinical validation remains pending.

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Market Size and Demand Dynamics

Current Indications and Market Penetration:
The total addressable market (TAM) for neratinib centers on HER2-positive breast cancer, with estimates indicating approximately 340,000 new cases worldwide annually (WHO, 2020)[3]. Within this, early-stage patients eligible for adjuvant therapy constitute a subset, estimated at roughly 15-20% of breast cancer cases. The drug's approval targets this niche, but uptake remains heterogeneous, influenced by clinician familiarity, side effect management, and competition.

Competitive Landscape:
Neratinib faces competition from established therapies such as trastuzumab, pertuzumab, and T-DM1. Its advantage lies in oral administration and potential efficacy in trastuzumab-resistant populations. However, side effect management, particularly diarrhea, acts as a barrier. Emerging therapies, including novel antibody-drug conjugates and biosimilars, could constrain market share.

Market Drivers:

• Expanded indications: Potential approval for metastatic or other HER2-positive cancers could extend its reach.
• Patient preference: Oral administration favors outpatient management, increasing adherence.
• Clinical outcomes: Demonstrated improvements post-trastuzumab resistance could underpin increased usage.

Market Barriers:

• Side effect profile: Diarrhea management remains critical; adverse events could limit patient eligibility.
• Cost considerations: High drug price and insurance reimbursement policies influence prescribing patterns.
• Regulatory delays: Variability in approval timelines affects global market penetration.

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Financial Trajectory and Revenue Projections

Historical Sales Data:
Since its approval, neratinib’s sales have been modest. Puma Biotechnology reported global revenues of approximately $23 million for 2021, with North America accounting for a significant portion (Puma Biotechnology, 2022)[4]. The incremental nature of early approvals and moderate market penetration contribute to these figures.

Forecasting Future Revenue:
Projections hinge on factors such as extended indications, increased adoption, and pipeline success. Several scenarios are plausible:

• Optimistic Scenario: Elevated demand following approval for metastatic HER2-positive breast cancer and potential other cancers, leading to peak annual sales surpassing $200 million within 5 years.
• Moderate Scenario: Steady growth owing to incremental indications, reaching approximately $50-$100 million annually in 3-5 years.
• Conservative Scenario: Market stagnation due to side effects, high competition, or delays in expanding indications, maintaining revenues below $50 million.

The adoption rate depends strongly on the drug’s safety profile management, clinician acceptance, and insurance reimbursement policies. As of 2023, efforts to mitigate adverse effects and demonstrate real-world benefits are central to growth strategies.

Impact of Manufacturing and Pricing:
Pricing strategies significantly influence revenue. Given the competitive landscape, premium positioning based on efficacy and convenience justifies higher pricing. Manufacturing capacity expansion supports meet demand if prescriptions increase.

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Market Challenges and Opportunities

Challenges:

• Managing side effects, especially diarrhea, is critical; failure to do so may restrict usage.
• Competition from alternative therapies and biosimilars could erode market share.
• Limited awareness and clinical familiarity hinder larger adoption rates; educational initiatives are essential.

Opportunities:

• Potential label expansion into metastatic settings and other HER2-driven cancers.
• Combination regimens with other targeted agents could boost efficacy and adoption.
• Developing next-generation formulations (e.g., lower dose, improved tolerability) may expand eligible patient populations.

Regulatory and Policy Landscape:
Ongoing negotiations with regulatory bodies and payer coverage decisions impact the financial trajectory. Favorable reimbursement and global approvals will enhance revenue streams.

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Conclusion

Neratinib maleate’s market dynamics are characterized by a niche yet promising position within HER2-positive breast cancer therapy. Its financial trajectory hinges upon successful expansion of indications, management of adverse effects, and competitive positioning within oncology therapeutics. While current revenues reflect modest uptake, strategic efforts to broaden clinical applications and improve tolerability could unlock substantial growth over the next decade.

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Key Takeaways

• Market Potential: Neratinib’s primary market remains HER2-positive early-stage breast cancer, with potential expansion into metastatic and other HER2-driven cancers.
• Revenue Drivers: Expansion of indications, improved tolerability, and clinician adoption are core drivers of future revenue growth.
• Challenges: Side effect management, competitive pressures, and regulatory hurdles are significant obstacles.
• Growth Strategies: Focused on clinical trial success, combination therapies, and global regulatory approvals.
• Financial Outlook: Depending on clinical and regulatory developments, neratinib’s revenues could range from modest figures to substantial growth within 5 years.

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FAQs

1. What are the main factors influencing neratinib’s market growth?
Clinical efficacy, side effect management, regulatory approvals, and competitive positioning primarily drive its market expansion.

2. How does side effect management impact neratinib’s adoption?
Diarrhea is a significant adverse event; effective management protocols can improve tolerability and increase prescribing.

3. What are potential future indications for neratinib?
Possible approval in metastatic HER2-positive breast cancer and other HER2-driven tumors like gastric and colorectal cancers could broaden its market.

4. How does competition affect neratinib’s financial prospects?
Other HER2-targeted therapies and biosimilars may restrict market share unless neratinib demonstrates superior efficacy or convenience.

5. What strategies could Puma Biotechnology implement to accelerate growth?
Expanding indications, improving adverse event profiles, engaging in strategic partnerships, and expanding global regulatory filings are key strategies.

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References

[1] FDA. (2017). Neratinib Approval for HER2-positive Breast Cancer. U.S. Food and Drug Administration.

[2] National Cancer Database. (2020). Clinical Trial Data on Neratinib.

[3] WHO. (2020). Global Cancer Statistics.

[4] Puma Biotechnology. (2022). Annual Financial Report.