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 one hundred and eighty-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:	189
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	3
Patent Applications:	281
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

Constraining patent/regulatory exclusivity:

7,399,865

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
Korean Cancer Study Group	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	9,630,946
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	8,518,446		Y
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	9,139,558
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	10,035,788

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	6,288,082

International Patents for NERATINIB MALEATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3088398	SELS DE MALEATE DE (E)-N-{4-[3-CHLORO-4-(2-PYRIDINYLMETHOXY)ANILINO]-3-CYANO-7-ETHOXY-6-QUINOLINYL}-4-(DIMETHYLAMINO)-2-BUTENAMIDE ET LEURS FORMES CRISTALLINES (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)
South Korea	101208301
Israel	247609	משטר טיפול לסרטן השד העושה שימוש בנראטיניב (Treatment regimen utilizing neratinib for breast cancer)
Canada	2730715	COMBINAISONS ANTINEOPLASIQUES DE 4-ANILINO-3-CYANOQUINOLEINES ET DE CAPECITABINE (ANTINEOPLASTIC COMBINATIONS OF 4-ANILINO-3-CYANOQUINOLINES AND CAPECITABINE)

Supplementary Protection Certificates for NERATINIB MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3000467	122023000045	Germany		PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180831
3000467	PA2023520	Lithuania		PRODUCT NAME: NERATINIBAS; REGISTRATION NO/DATE: EU/1/18/1311 20230526
3000467	LUC00310	Luxembourg		PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904
3000467	301237	Netherlands		PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180904

NERATINIB MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neratinib Maleate

Introduction to Neratinib Maleate

Neratinib maleate, marketed under the trade name Nerlynx, is an orally available small molecule kinase inhibitor that irreversibly binds to Epidermal Growth Factor Receptor (EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), and HER4. It is approved for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy, as well as for the treatment of HER2-positive metastatic breast cancer in combination with capecitabine[4][5].

Market Players and Competition

The key players in the neratinib maleate market include Puma Biotechnology, Beacon Pharma, and Drug International. Puma Biotechnology is the primary applicant and developer of Nerlynx, and it plays a significant role in the market dynamics of this drug[1].

Market Segmentation

The market for neratinib maleate can be segmented by type and application. The types include original drugs and generic drugs, although currently, neratinib maleate is primarily available as an original drug. The applications include hospital and clinic settings, retail pharmacies, and other healthcare facilities[1].

Clinical Indications and Approval

Neratinib maleate is approved for two main indications:

• Extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy.
• Treatment of HER2-positive metastatic breast cancer in combination with capecitabine for patients who have received at least two other anti-HER2 therapies[4][5].

Economic Evaluation and Cost-Effectiveness

The economic evaluation of neratinib maleate has been a subject of extensive analysis. A study submitted to the pan-Canadian Oncology Drug Review (pCODR) compared neratinib to best supportive care (BSC) for patients with early-stage HER2-positive breast cancer. The analysis indicated that neratinib was associated with an incremental cost of $55,779 and generated an additional 1.19 Quality-Adjusted Life Years (QALYs) over a 55-year time horizon, resulting in an incremental cost-effectiveness ratio (ICER) of $46,936 per QALY gained. However, there is substantial uncertainty surrounding the cost-effectiveness estimate, and a price reduction could improve the cost-effectiveness of neratinib[2].

Budget Impact Analysis

A budget impact analysis conducted in the US estimated the financial implications of introducing neratinib as a third-line treatment for HER2-positive metastatic breast cancer. The study found that the introduction of neratinib could potentially reduce total annual health plan costs by $2.2 million ($0.04 per-member-per-month) for equally distributed market shares and $890,299 ($0.01 per-member-per-month) for clinical expert market shares over a five-year period. This reduction is attributed to the lower costs associated with neratinib compared to other treatment regimens like lapatinib and tucatinib[3].

Financial Trajectory and Market Forecast

The global neratinib maleate tablets market is expected to grow significantly over the forecast period. While the exact market value and growth rate are not specified in the available sources, the market is anticipated to expand due to the increasing incidence of HER2-positive breast cancer and the approval of neratinib for additional indications.

Revenue and Volume Forecast

The market forecast includes revenue and volume projections, indicating a steady growth trajectory driven by the drug's efficacy and the expanding patient population. The main cost drivers include the acquisition cost of neratinib and the costs associated with treating recurrence, which are significant factors in the overall financial trajectory[2].

Competitive Landscape

The competitive landscape is influenced by other anti-HER2 therapies such as lapatinib, tucatinib, and fam-trastuzumab deruxtecan-nxki. Neratinib's unique mechanism of action and its approval for specific indications position it competitively in the market. However, the presence of other effective treatments and the high cost of neratinib are challenges that need to be addressed[3].

Adverse Events and Management

Neratinib is associated with several adverse events, including diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, and muscle spasms. The management of these adverse events, particularly diarrhea, is crucial and can involve antidiarrheal prophylaxis to reduce the incidence and severity[4].

Research and Development

Neratinib maleate is also being studied in the treatment of other types of cancer, indicating potential future market expansion. Ongoing clinical trials and research are aimed at exploring its efficacy in various cancer types and improving its safety profile[5].

Key Takeaways

• Market Players: Puma Biotechnology, Beacon Pharma, and Drug International are key players.
• Clinical Indications: Extended adjuvant treatment for early-stage HER2-positive breast cancer and treatment of HER2-positive metastatic breast cancer.
• Economic Evaluation: Neratinib shows a favorable ICER but with substantial uncertainty, suggesting potential for improved cost-effectiveness with price adjustments.
• Budget Impact: Introduction of neratinib can reduce health plan costs by minimizing the use of more expensive regimens.
• Financial Trajectory: Expected growth driven by increasing incidence of HER2-positive breast cancer and expanding patient population.
• Competitive Landscape: Competitive with other anti-HER2 therapies, with a unique mechanism of action.

FAQs

What is neratinib maleate used for?

Neratinib maleate is used for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy, and for the treatment of HER2-positive metastatic breast cancer in combination with capecitabine[4][5].

Who are the main players in the neratinib maleate market?

The main players in the neratinib maleate market include Puma Biotechnology, Beacon Pharma, and Drug International[1].

What are the common adverse events associated with neratinib maleate?

Common adverse events include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, and muscle spasms[4].

How does neratinib maleate impact health plan costs?

The introduction of neratinib can potentially reduce total annual health plan costs by minimizing the use of more expensive treatment regimens[3].

What is the current status of neratinib maleate in clinical trials?

Neratinib maleate is being studied in various ongoing clinical trials to explore its efficacy in different types of cancer and to improve its safety profile[5].

Cited Sources

1. Global Neratinib Maleate Tablets Market Research Report 2024 - Valuates Reports
2. pan-Canadian Oncology Drug Review Initial Economic Guidance Report - Neratinib (Nerlynx) for Early Breast Cancer - pCODR
3. Budget impact of introducing neratinib for third-line treatment of human epidermal growth factor receptor 2-positive metastatic breast cancer - RTI Health Solutions
4. NDA/BLA Multi-disciplinary Review and Evaluation NDA 208051 NERLYNX (neratinib) - FDA
5. Neratinib Maleate - National Cancer Institute (NCI)