ERLOTINIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for erlotinib hydrochloride and what is the scope of patent protection?

Erlotinib hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alembic, Apotex, Chartwell Rx, Eugia Pharma, Hetero Labs Ltd V, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, Zydus Pharms, and Osi Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for erlotinib hydrochloride. Eleven suppliers are listed for this compound.

Summary for ERLOTINIB HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	838
Patent Applications:	2,911
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERLOTINIB HYDROCHLORIDE
What excipients (inactive ingredients) are in ERLOTINIB HYDROCHLORIDE?	ERLOTINIB HYDROCHLORIDE excipients list
DailyMed Link:	ERLOTINIB HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ERLOTINIB HYDROCHLORIDE

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

Sponsor	Phase
Northwestern University	PHASE1
Yale University	PHASE1
Mayo Clinic	PHASE2

See all ERLOTINIB HYDROCHLORIDE clinical trials

Pharmacology for ERLOTINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for ERLOTINIB HYDROCHLORIDE

Antineoplastic Agents

Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ERLOTINIB HYDROCHLORIDE

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ERLOTINIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARCEVA	Tablets	erlotinib hydrochloride	25 mg	021743	1	2008-11-18

US Patents and Regulatory Information for ERLOTINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	214719-003	Jul 8, 2021	AB	RX	No	No
Natco Pharma Ltd	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	208488-003	Nov 5, 2019		DISCN	No	No
Teva Pharms Usa Inc	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	091059-002	Aug 28, 2015	AB	RX	No	No

Expired US Patents for ERLOTINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004

Market Dynamics and Financial Trajectory for Erlotinib Hydrochloride

Last updated: July 28, 2025

Introduction

Erlotinib hydrochloride, marketed under brand names such as Tarceva and Erbitux, is a targeted therapy primarily used in treating non-small cell lung cancer (NSCLC) and pancreatic cancer. As an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, erlotinib has gained prominence in oncology, driven by advances in personalized medicine. This article analyzes the evolving market landscape for erlotinib hydrochloride, including key drivers, competitive dynamics, and financial outlooks shaping its future trajectory.

Market Overview

The global oncology therapeutics market was valued at approximately USD 150 billion in 2022, with targeted therapies like erlotinib constituting a significant share. The increasing incidence of lung and pancreatic cancers—both linked to high mortality rates—has underscored the demand for efficacious targeted treatments. Erlotinib's role as a first-line therapy for EGFR-mutated NSCLC and its approval in combination regimens contribute to sustained market relevance.

Market Drivers

1. Rising Incidence of Target Cancers

Lung cancer remains the leading cause of cancer-related deaths worldwide, with an estimated 2.2 million new cases in 2020 [1]. Non-small cell lung cancer accounts for 85% of all lung cancers, many of which harbor EGFR mutations. Pancreatic cancer, characterized by poor prognosis, continues to see rising incidence globally. The increasing burden of these cancers fuels demand for targeted therapeutics like erlotinib.

2. Advances in Precision Oncology

Genetic profiling enables identification of patients with EGFR mutations, enhancing erlotinib's therapeutic efficacy. The FDA's approval of companion diagnostics for EGFR mutation testing has optimized patient selection. This precision approach boosts treatment success rates, reinforcing erlotinib’s market position.

3. Regulatory Endorsements and Evolving Indications

Erlotinib's approvals in multiple geographies—America, Europe, and Asia—expand its accessible patient base. Ongoing clinical trials aim to expand indications to other EGFR-mutated cancers, such as brain metastases and gastrointestinal malignancies, promising future growth avenues.

4. Competitive Landscape and Patent Dynamics

While originally protected by patents held by Osimertinib (AstraZeneca) and others, erlotinib faced patent expirations, paving the way for generic competition. The expiration of its primary patents around 2015 in several markets increased accessibility but exerted pricing pressure, impacting revenue streams.

Market Challenges

1. Emergence of Next-Generation EGFR Inhibitors

Third-generation EGFR inhibitors like osimertinib exhibit superior efficacy and reduced resistance, leading clinicians to favor these over erlotinib. As resistance mechanisms (e.g., T790M mutation) develop, erlotinib’s utility diminishes, impacting long-term sales.

2. Side Effect Profile and Patient Preferences

Common adverse effects—rash, diarrhea, and stomatitis—limit tolerability in some patients. The emergence of better-tolerated therapies further constrains erlotinib’s market share.

3. Patent and Market Entry Dynamics

Generic erosion after patent expiry has resulted in significant price reductions, challenging profitability for originator companies. Strategic lifecycle management, including combination therapies, becomes vital to sustain revenue.

Financial Trajectory Analysis

Revenue Trends

Historical revenue analysis indicates a peak in erlotinib sales in the early 2010s, coinciding with its initial blockbuster status. Post-patent expiration, revenues declined sharply due to generic competition. For instance, in 2014, revenues exceeded USD 1 billion globally but fell below USD 300 million by 2020 [2].

Profitability and R&D Investment

While patent protection yielded high margins, the shift towards generics decreased profitability. Companies invested in pipeline expansion, including combination regimens with immunotherapies or chemotherapy agents, to mitigate revenue loss.

Pipeline and New Indications

Ongoing investigational studies explore erlotinib’s combination with immune checkpoint inhibitors and as part of neoadjuvant protocols. Positive trial outcomes could revitalize its market positioning and extend its financial trajectory.

Competitive Landscape

Main Players

• Genentech (Roche): Previously marketed erlotinib as Tarceva.
• AstraZeneca: Focused on osimertinib and other EGFR therapies.
• Generic Manufacturers: Numerous companies now produce erlotinib generics, significantly reducing prices and margins.

Pipeline Development and Lifecycle Management

Manufacturers employ strategies such as proprietary combination products and regional licensing agreements to maximize product longevity and revenue streams.

Future Outlook and Strategic Considerations

The erlotinib market faces a transitional phase. The shift towards next-generation inhibitors and the advent of immuno-oncology agents are likely to curtail erlotinib’s prominence. However, niche applications—such as elderly or frail patients intolerant to newer therapies—and combination regimens could sustain moderate sales. Additionally, emerging markets with expanding healthcare infrastructure offer growth opportunities owing to lower drug costs and increasing cancer prevalence.

Regulatory and Pricing Dynamics

Pricing pressures, healthcare reforms, and reimbursement policies significantly influence erlotinib’s financial prospects. Countries implementing value-based pricing models may restrict revenues further, emphasizing the need for strategic diversification.

Key Takeaways

• Market Growth: The erlotinib market has peaked but remains relevant in specific niches, especially where EGFR mutations predominate.

• Revenue Decline: Patent expiries and competition from superior agents led to substantial revenue erosion post-2015.

• Innovation and Expansion: Pipeline efforts targeting combination therapies and new indications could slow sales decline or generate new revenue streams.

• Competitive Landscape: Generic proliferation has distorted pricing and margins; exclusive formulations or indications are critical for sustained profitability.

• Regional Opportunities: Emerging markets and personalized medicine strategies present future growth avenues despite overall market contraction.

Conclusion

Erlotinib hydrochloride’s market dynamics are characterized by significant historical growth, now transitioning through patent expiries and technological competition. Its financial trajectory reflects this evolution, with declining revenues offset by strategic pipeline development and targeted therapy integrations. Future success hinges on innovation, regional expansion, and adaptiveness within the rapidly advancing oncology landscape.

---

FAQs

1. What are the primary factors influencing erlotinib's market decline?
Patent expirations, competition from next-generation EGFR inhibitors, and the development of resistance mechanisms have led to reduced market share and revenues.

2. How does the emergence of osimertinib impact erlotinib's sales?
Osimertinib demonstrates superior efficacy in overcoming resistance mutations, making it the preferred first-line treatment in many cases, thereby diverting erlotinib’s market share.

3. Are there regional opportunities for erlotinib?
Yes. Countries with emerging healthcare infrastructure and high cancer incidences, especially in Asia, still utilize erlotinib, often at lower drug costs, providing growth potential.

4. What strategies are manufacturers employing to prolong erlotinib’s lifecycle?
Companies focus on combination therapies, new indications, and regional licensing to extend product relevance and revenue.

5. What is the outlook for erlotinib in personalized medicine?
As genetic profiling becomes standard, erlotinib’s role in treating EGFR-mutant cancers remains valuable in specific patient populations, supporting niche markets amid broader shifts.

---

References

[1] World Health Organization. (2020). Cancer Incidence and Mortality Worldwide.

[2] IQVIA. (2021). Oncology Market Data and Trends.