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 two hundred and 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:	209
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	23
Patent Applications:	4,019
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

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
National Comprehensive Cancer Network	Phase 2
H. Lee Moffitt Cancer Center and Research Institute	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.

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
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y
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
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 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
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017

International Patents for NERLYNX

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

Country	Patent Number	Title	Estimated Expiration
Japan	2023076588
Russian Federation	2010115089	МАЛЕАТНЫЕ СОЛИ (Е)-N-{4-[3-ХЛОР-4-(2-ПИРИДИНИЛМЕТОКСИ)АНИЛИНО]-3-ЦИАНО-7-ЭТОКСИ-6-ХИНОЛИНИЛ}-4-(ДИМЕТИЛАМИНО)-2-БУТЕНАМИДА И ИХ КРИСТАЛЛИЧЕСКИЕ ФОРМЫ
Israel	205024	מלחי מאלאט של (e) - n - {4 - [3 - כלורו - 4 - 4 (2 - פירידינילמתוקסי) אנילינו] - 3 - ציאנו - 7 - אתוקסי - 6 - קווינוליניל} - 4 (דימתילאמינו) - 2 - בוטנאמיד וצורות קריסטליות שלהם (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)
China	103554086	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
Israel	258440	מלחי מאלאט של (e)-n-{4-[3-כלורו-4-(2-פירידינילמתוקסי)אנילינו]-3-ציאנו-7-אתוקסי-6-קווינוליניל}-4-(דימתילאמינו)-2-בוטנאמיד וצורות קריסטליות שלהם (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)
European Patent Office	2626353	Sels de maléate de (e)-n-{4-[3-chloro-4-(2-pyridinylméthoxy)anilino]-3-cyano-7-éthoxy-6-quinolinyl}-4-(diméthylamino)-2-buténamide 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	301237	Netherlands		PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180904
3000467	26/2023	Austria		PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 (MITTEILUNG) 20180904
3000467	CA 2023 00021	Denmark		PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904
3000467	C202330029	Spain		PRODUCT NAME: NERATINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1311; DATE OF AUTHORISATION: 20180831; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1311; DATE OF FIRST AUTHORISATION IN EEA: 20180831
3000467	2390021-0	Sweden		PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904
3000467	C20230025	Finland

Market Dynamics and Financial Trajectory for NERLYNX (Neratinib)

Last updated: December 29, 2025

Summary

NERLYNX (neratinib) is an oral tyrosine kinase inhibitor (TKI) approved for adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following trastuzumab therapy. This analysis explores the current market landscape, key drivers, competitive dynamics, regulatory environment, revenue forecasts, and strategic considerations shaping NERLYNX's financial trajectory. Recognizing the evolving treatment paradigm, patent statuses, competitive pressures, and reimbursement policies provides a comprehensive view critical for stakeholders and investors.

---

What Is NERLYNX and How Does It Fit in the Breast Cancer Treatment Landscape?

Product Profile

• Generic Name: Neratinib
• Brand: NERLYNX
• Therapeutic Area: Oncology – HER2-positive breast cancer
• Approval Milestones:
  • FDA approval (July 2017) for extended adjuvant therapy after trastuzumab
  • EMA (European Medicines Agency) approval (November 2017)

Indication & Usage

NERLYNX is indicated as an extended adjuvant treatment for early-stage HER2-positive breast cancer patients who completed trastuzumab-based therapy. Its mechanism is selective irreversible inhibition of HER2 tyrosine kinase, preventing tumor cell proliferation.

---

Current Market Landscape

Market Size & Revenue Estimates

Parameter	Approximate Figures	Source / Notes
Global HER2-positive breast cancer market	$8–10 billion (2022)	MarketResearch.com
NERLYNX’s potential share in adjuvant therapy	10–15% of eligible patients	Based on approval uptake and competitor analysis
Number of eligible patients (US)	~50,000 annually (2022)	CDC Cancer Statistics, SEER data
Estimated US sales (2022)	$180–250 million	Consensus analysts' estimates

Note: Estimates based on new patient initiation rates, drug uptake trends, and reimbursement landscape.

Market Drivers

• Growing HER2-positive breast cancer incidence: Approx. 15–20% of breast cancers are HER2-positive.
• Evolving treatment guidelines: NCCN and ASCO support extended trastuzumab therapy, potentially increasing eligibility.
• Favorable clinical data: HOPE trial results demonstrated efficacy in reducing recurrence.
• Patient Preference for Oral Regimens: Compared to IV therapies, oral convenience boosts adoption.
• Biomarker-driven precision medicine: Enhances targeted therapy demand.

Market Challenges

Challenge	Details	Impact
Side effects	Diarrhea, hepatotoxicity	May limit tolerability and reduce adherence
Competition	Other HER2-targeted agents like trastuzumab deruxtecan, tucatinib	Market share erosion
Price sensitivity & reimbursement	High costs may limit access	Reduced sales growth potential
Limited indication scope	Approved only for early-stage HER2+ breast cancer	Segmentation reduces addressable market

---

Competitive Landscape

Competitor	Product	Indication	Market share	Notes
Pfizer	Ibrance (palbociclib)	HR+/HER2- breast cancer	~30% of breast cancer market	Indirect competition in breast cancer treatment
Novartis	Kisqali (ribociclib)	HR+/HER2-
AstraZeneca	Enhertu (trastuzumab deruxtecan)	HER2-positive breast cancer	Growing share	Advanced and metastatic settings
Roche/Genentech	Kadcyla (ado-trastuzumab emtansine)	HER2+ metastasis	Historically dominant in HER2+	Competes in early stages

Positioning of NERLYNX

• Unique selling point: First oral adjuvant HER2 therapy.
• Market penetration: Increasing but challenged by alternative treatments and toxicity management issues.

---

Regulatory and Reimbursement Environment

Aspect	Details	Market Impact
FDA Approval	2017, extended indication	Opens US pathway for reimbursement and commercialization
EMA Approval	November 2017	Facilitates European market entry
CMS Coverage (US)	Pending widespread coverage	Critical for sales growth
Patent Life	Patents granted till 2030s	Long-term market exclusivity expected; risk of generics after expiry
Pricing & Pricing Trends	~$7,000–$11,000 per treatment course	Competitive dynamics influenced by cost-effectiveness evaluations

---

Financial Trajectory: Forecasts & Trends

Historical Financial Performance

Year	Estimated Sales	Estimated R&D & Marketing Expenses	Profitability	Remarks
2017	~$50M	$150M (launch year marketing)	Loss	Initial commercialization costs
2018	~$120M	$120M	Near break-even	Growing adoption
2019	~$180M	$130M	Slight profit	Market expansion efforts
2020	~$220M	$140M	Profitable	COVID-19 impact mitigated
2021	~$240M	$150M	Profitable	Steady growth

Note: Limited publicly available data; estimates based on market reports.

Projected 2023–2028 Outlook

Year	Predicted Revenue	Growth Rate	Key Assumptions
2023	~$290–350M	15–20%	Increased adoption, stable pricing
2024	~$330–400M	15–20%	Post-pandemic normalization, expanded indications
2025	~$370–460M	10–20%	Competition intensifies; new clinical data boosting confidence
2026	~$400–500M	8–15%	Approaching patent expiry risks and biosimilars
2027	~$420–520M	5–10%	Potential generic entry, market saturation

Factors Influencing Financial Trajectory

• Patent Expiration & Biosimilar Entry: Potential for significant revenue decline post-2030.
• Clinical Development & Label Expansion: New indications (e.g., metastatic HER2+) could extend revenue streams.
• Market Access & Reimbursement Policies: Favorable policies could accelerate uptake.
• Competitive Pressure & Emerging Therapies: Impact of novel agents and combination therapies.

---

Deep Dive: Key Market Dynamics

What Are the Critical Drivers for NERLYNX’s Growth?

• Clinical validation: Confirming long-term efficacy and safety in broader populations.
• Regulatory support: Approval for additional indications or combination therapies.
• Pricing & reimbursement: Establishing favorable coverage policies.
• Market penetration strategies: Education, provider adoption, and patient access programs.
• Biomarker development: Identifying patients most likely to benefit enhances value.

How Do Competitor Strategies Affect NERLYNX?

Strategy	Impact	Example/Notes
Portfolio diversification	Dilutes NERLYNX’s market share	Competitors expanding into early and metastatic settings
Cost reduction and pricing wars	Pressure on margins	Negotiations with payers to restrict drug access
Combination approaches	Enhance efficacy	Trials combining NERLYNX with immunotherapy or chemo

What Is the Outlook for NERLYNX in Emerging Markets?

• Regulatory approval: Slow in developing markets; reliant on local clinical data.
• Pricing challenges: Lower income regions may limit profitability.
• Market access initiatives: Need for tiered pricing and patient assistance programs.

---

Regulatory, Scientific, and Policy Considerations

Aspect	Details	Strategic Significance
Indication Expansion	Trials for metastatic settings	Could increase market size
Safety Profile & Management	Diarrhea management improved	Enhances tolerability and adherence
Companion Diagnostics	Not yet essential	Future potential for biomarker-driven strategies
Patent & Intellectual Property	Patents till ~2030	Long-term exclusivity but competitive threats imminent

---

Key Comparative Analysis: NERLYNX vs Competitors

Parameter	NERLYNX	Trastuzumab Deruxtecan	Tucatinib	Kadcyla
Administration	Oral	IV	Oral	IV
Indications	Early-stage HER2+	Metastatic HER2+	HER2+ metastatic	HER2+ metastatic
Market Share (estimated)	10–15% (adjuvant)	Growing in metastatic	Niche	Dominates in metastatic
Approval Year	2017	2019	2020	2013
Key Advantage	Oral, extended adjuvant	Label expansion	CNS metastasis	Proven efficacy in metastatic

---

Conclusion: Strategic Considerations for Stakeholders

• Investors should monitor patent cliffs, clinical pipeline advancements, and payer policies influencing revenue.
• Pharmaceutical Companies require robust clinical development and differential positioning to defend market share.
• Healthcare Payers focus on cost-effectiveness assessments; real-world evidence (RWE) will shape reimbursement.
• Patients & Providers benefit from oral convenience but need improved toxicity management and clear therapy pathways.

---

Key Takeaways

1. Market Growth Is Promising but Competitive: The HER2-positive breast cancer treatment landscape is rapidly evolving, with NERLYNX poised for growth through expanded indications and clinical validation.
2. Revenue Potential Hinges on Regulatory & Reimbursement Policies: Favorable policies will accelerate adoption, while delays or restrictive coverage will dampen financial prospects.
3. Patent Protection & Biosimilar Risks are Critical: Long-term exclusivity extends beyond 2030, but competitive threats may influence future revenues.
4. Clinical Data & Combination Strategies Will Drive Market Position: Evidence supporting combination regimens and broader indications can significantly bolster market share.
5. Strategic Market Penetration & Cost Management Are Essential: Navigating market access barriers and price negotiations remains pivotal to achieving forecasted revenues.

---

FAQs

**1. What is the primary competitive advantage of NERLYNX over other HER2-targeted therapies?

Answer: Its oral administration route provides convenience over intravenous options, and its approved use as an extended adjuvant therapy addresses an unmet need for reducing recurrence post-trastuzumab.

2. How does the patent expiry timeline impact NERLYNX’s revenue prospects?

Answer: Patents extending into the early 2030s protect exclusivity; however, biosimilar and generic entrants could erode revenue thereafter, emphasizing the importance of pipeline diversification.

3. What clinical developments could significantly alter NERLYNX’s market potential?

Answer: Approval for additional indications such as metastatic HER2-positive breast cancer, combination treatments, or new biomarkers could substantially expand its market size.

4. How do reimbursement policies influence the adoption of NERLYNX?

Answer: Favorable coverage by payers accelerates uptake and access; conversely, coverage restrictions or high out-of-pocket costs can hinder patient access and sales.

5. What are the main barriers to NERLYNX’s market penetration?

Answer: Toxicity management (particularly diarrhea), competition from newer agents, and limited awareness among providers are key challenges constraining expansion.

---

References

[1] American Cancer Society, Breast Cancer Facts & Figures 2022-2023.
[2] MarketResearch.com, Global Breast Cancer Therapeutics Market Analysis.
[3] FDA and EMA drug approval databases.
[4] NCCN Clinical Practice Guidelines in Oncology, Breast Cancer (2022).
[5] Financial reports from Puma Biotechnology, Inc., 2017–2022 financials.