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NERLYNX Drug Patent Profile

Which patents cover Nerlynx, and what generic alternatives are available?

Nerlynx is a drug marketed by Puma Biotech and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-nine patent family members in thirty-five countries.

The generic ingredient in NERLYNX is neratinib maleate. One supplier is listed for this compound. Additional details are available on the neratinib maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nerlynx

Nerlynx was eligible for patent challenges on July 17, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 29, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (neratinib maleate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NERLYNX

International Patents:	189
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	23
Patent Applications:	882
Drug Prices:	Drug price information for NERLYNX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NERLYNX
What excipients (inactive ingredients) are in NERLYNX?	NERLYNX excipients list
DailyMed Link:	NERLYNX at DailyMed

See drug prices for NERLYNX

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

Constraining patent/regulatory exclusivity:

7,399,865

NDA:

208051

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 NERLYNX

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
H. Lee Moffitt Cancer Center and Research Institute	Phase 2
National Comprehensive Cancer Network	Phase 2

See all NERLYNX clinical trials

Pharmacology for NERLYNX

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

Paragraph IV (Patent) Challenges for NERLYNX

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 NERLYNX

NERLYNX is protected by twenty-three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 7,399,865.

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
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	7,982,043
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	8,790,708		Y

Expired US Patents for NERLYNX

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 NERLYNX

See the table below for patents covering NERLYNX around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5681108
China	105999264	用于乳腺癌的利用奈拉替尼的治疗方案 (Treatment regimen utilizing neratinib for breast cancer)
Canada	2702930	SELS MALEATES 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)

Supplementary Protection Certificates for NERLYNX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3000467	CA 2023 00021	Denmark		PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904
3000467	2390021-0	Sweden		PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904
3000467	301237	Netherlands		PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180904

NERLYNX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NERLYNX

Introduction to NERLYNX

NERLYNX, also known as neratinib, is an oral tyrosine kinase inhibitor developed by Puma Biotechnology. It is primarily used as an extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy[4].

Market Approval and Expansion

NERLYNX received FDA approval in 2017 for the extended adjuvant treatment of early-stage HER2-positive breast cancer. It has also been granted marketing authorization by the European Commission in 2018 for similar indications. Puma Biotechnology has entered into various exclusive license agreements to commercialize NERLYNX in regions outside the United States, including the European Union, Canada, Latin America, Greater China, Israel, Southeast Asia, Australia, New Zealand, South Korea, the Middle East, and parts of Africa[1][4].

Target Patient Population

The primary target population for NERLYNX in the United States is approximately 28,300 patients with early-stage HER2-positive breast cancer who have completed prior adjuvant trastuzumab-based therapy. This population is at a high risk of recurrence, and NERLYNX aims to reduce this risk[1].

Sales Performance

Recent Financial Results

In 2022, Puma Biotechnology reported $200 million in NERLYNX sales, representing a 5.8% increase from the $189.1 million in 2021. This growth contributed to the company achieving break-even net income for the full year 2022, a significant improvement from the net loss of $29.1 million in 2021[1].

For the fourth quarter of 2023, NERLYNX sales contributed $53.2 million to the total revenue of $72.2 million. For the full year 2023, product revenue from NERLYNX was $203.1 million, part of the total revenue of $235.6 million[2].

Quarterly Trends

In Q3 2024, NERLYNX sales continued to show growth, contributing $56.1 million to the total revenue of $80.5 million. This represents an increase from $44.4 million in the previous quarter. The number of bottles sold also increased, with 2,723 bottles sold in Q3 2024, up from 2,515 in Q2 2024[3].

Revenue Streams

Product Revenue

The majority of Puma Biotechnology's revenue comes from the sales of NERLYNX. In 2023, product revenue from NERLYNX was $203.1 million, and for Q3 2024, it was $56.1 million[2][3].

Royalty Revenue

In addition to product sales, Puma Biotechnology generates significant royalty revenue. For the fourth quarter of 2023, royalty revenue was $19.0 million, and for the full year 2023, it was $32.5 million. The Q3 2024 royalty revenue jumped to $24.4 million, largely due to strong sales in the Chinese market[2][3].

Clinical and Commercial Strategies

Puma Biotechnology is actively engaged in clinical trials to expand the indications for NERLYNX and its other drug candidates. The company initiated a Phase II clinical trial, ALISCA-Lung1, for the treatment of patients with extensive stage small cell lung cancer and plans to start a trial combining alisertib with endocrine treatment for certain types of metastatic breast cancer in Q4 2024[2][3].

Distribution Model

NERLYNX is primarily distributed through the specialty pharmacy channel, which accounted for about 74% of the business in Q3 2024. This model helps in ensuring that the medication reaches the target patient population efficiently[3].

Financial Outlook

Puma Biotechnology anticipates continued growth in NERLYNX sales. For the full year 2024, the company projects net product revenue for NERLYNX to be between $187 million and $290 million. The Q4 2024 net product revenue is expected to range from $46 million to $48 million, with royalties estimated at $3.5 million to $5 million[3].

Operational Costs and Expenses

The company has been managing its internal expenses to maintain fiscal responsibility. Despite lower enrollments and higher gross to net adjustments in Q3 2023, Puma Biotechnology reduced its internal expenses to ensure positive net income in 2024[2].

Regulatory and Clinical Milestones

NERLYNX has been included in several National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, which further validates its clinical utility. The company is also focused on the development of its pipeline, including alisertib, which is in various clinical trials[1][3].

Global Access and Partnerships

Puma Biotechnology has partnered with several companies to ensure global access to NERLYNX. For example, the license deal with Specialised Therapeutics Asia has made NERLYNX available in Australia, New Zealand, and Southeast Asia[4].

Challenges and Opportunities

Adverse Effects Management

One of the challenges associated with NERLYNX is the adverse effect of diarrhea. Puma Biotechnology has been working to mitigate this through various strategies, including the development of anti-diarrheal prophylaxis regimens[1].

Market Competition and Expansion

The breast cancer treatment market is competitive, but NERLYNX's unique positioning as an extended adjuvant therapy provides a significant market opportunity. The company's efforts to expand its reach through licensing agreements and clinical trials are crucial for its growth[1][4].

Key Takeaways

• Sales Growth: NERLYNX has shown consistent sales growth, with $200 million in sales in 2022 and projected revenue between $187 million and $290 million for 2024.
• Revenue Streams: Product revenue and royalty revenue are significant contributors to Puma Biotechnology's total revenue.
• Clinical Trials: Ongoing clinical trials, such as ALISCA-Lung1 and planned trials for metastatic breast cancer, are key to expanding NERLYNX's indications.
• Global Access: Partnerships and licensing agreements have made NERLYNX available in multiple regions worldwide.
• Financial Outlook: Puma Biotechnology anticipates positive net income and cash flow in 2024, driven by NERLYNX sales and royalty revenue.

FAQs

Q: What is NERLYNX used for?

A: NERLYNX (neratinib) is used as an extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

Q: How has NERLYNX performed in terms of sales?

A: NERLYNX sales have shown growth, with $200 million in sales in 2022 and projected revenue between $187 million and $290 million for 2024.

Q: What are the main revenue streams for Puma Biotechnology?

A: The main revenue streams are product revenue from NERLYNX sales and royalty revenue from licensing agreements.

Q: What are the ongoing clinical trials for NERLYNX and other Puma Biotechnology drugs?

A: Puma Biotechnology is conducting several clinical trials, including the ALISCA-Lung1 trial for small cell lung cancer and a planned trial combining alisertib with endocrine treatment for metastatic breast cancer.

Q: How is NERLYNX distributed?

A: NERLYNX is primarily distributed through the specialty pharmacy channel, which accounts for about 74% of the business.

Cited Sources

1. Puma Biotechnology 2022 Annual Report.
2. Puma Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results.
3. Earnings call: Puma Biotechnology reports robust Q3 growth.
4. New Early-Breast Cancer Drug to be Made Available in Australia, New Zealand and South East Asia following License Deal.