CLINICAL TRIALS PROFILE FOR ERLOTINIB HYDROCHLORIDE

505(b)(2) Clinical Trials for erlotinib hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	University of Arizona	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT02353741 ↗	Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC	Terminated	Xinqiao Hospital of Chongqing	Phase 2	2015-04-01	This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.
OTC	NCT03513393 ↗	Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.	Completed	Radboud University	Phase 1	2018-08-01	Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.

All Clinical Trials for erlotinib hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00026338 ↗	Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer	Completed	NCIC Clinical Trials Group	Phase 3	2001-10-29	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
NCT00030446 ↗	Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	Completed	NCIC Clinical Trials Group	Phase 2	2002-01-10	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
NCT00030485 ↗	Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer	Completed	NCIC Clinical Trials Group	Phase 2	2002-01-01	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.
NCT00030485 ↗	Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2002-01-01	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.
NCT00030498 ↗	Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction	Completed	National Cancer Institute (NCI)	Phase 1	2001-12-01	Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
NCT00030537 ↗	Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-11-01	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.
NCT00030576 ↗	Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2001-11-01	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer.

Clinical Trial Conditions for erlotinib hydrochloride

Condition Name

Condition Name for erlotinib hydrochloride
Intervention	Trials
Non-Small Cell Lung Cancer	119
Lung Cancer	66
Carcinoma, Non-Small-Cell Lung	52
Pancreatic Cancer	50

Condition MeSH

Condition MeSH for erlotinib hydrochloride
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	412
Lung Neoplasms	349
Carcinoma	89
Pancreatic Neoplasms	86

Clinical Trial Locations for erlotinib hydrochloride

Trials by Country

Trials by Country for erlotinib hydrochloride
Location	Trials
Italy	222
Germany	97
United Kingdom	93
Japan	78
Brazil	78

Trials by US State

Trials by US State for erlotinib hydrochloride
Location	Trials
California	168
Texas	149
New York	135
Florida	115
Illinois	110

Clinical Trial Progress for erlotinib hydrochloride

Clinical Trial Phase

Clinical Trial Phase for erlotinib hydrochloride
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	2
Phase 4	20

Clinical Trial Status

Clinical Trial Status for erlotinib hydrochloride
Clinical Trial Phase	Trials
Completed	495
Terminated	129
Unknown status	82

Clinical Trial Sponsors for erlotinib hydrochloride

Sponsor Name

Sponsor Name for erlotinib hydrochloride
Sponsor	Trials
National Cancer Institute (NCI)	171
Genentech, Inc.	110
Hoffmann-La Roche	72

Sponsor Type

Sponsor Type for erlotinib hydrochloride
Sponsor	Trials
Other	853
Industry	562
NIH	172

Last updated: July 28, 2026

Erlotinib Hydrochloride clinical trials update, market analysis, and generic/biosimilar exclusivity outlook

Erlotinib hydrochloride (Tarceva and generics) has mature clinical and regulatory history in non-small cell lung cancer (NSCLC) and pancreatic cancer. Newer “clinical trials updates” are mainly post-approval studies (new combinations, resistance biology, real-world evidence) and regimen refinements rather than broadly transformative phase 3 programs. From a patent-risk perspective, the core small-molecule franchise is predominantly past active primary exclusivity in most markets, with commercial exposure concentrated in ongoing brand-and-generic volume, line-of-therapy dynamics, and country-level reimbursement.

Is there meaningful new clinical development for erlotinib hydrochloride in 2025-2026?

Short answer: Mostly incremental programs (combination studies, biomarker-stratified studies, and real-world/onco-omics studies). No single late-stage breakthrough has re-established erlotinib as a dominant current standard of care versus osimertinib and other EGFR pathway agents.

What disease areas still use erlotinib?

1. NSCLC
   • EGFR-mutated metastatic NSCLC (historically after progression on earlier EGFR TKI therapy, and in settings where erlotinib remains used due to access and sequencing).
   • EGFR wild-type or unknown EGFR cohorts in combination or second-line settings in some regions.
2. Pancreatic cancer
   • Erlotinib plus gemcitabine has been a historical standard in parts of the world; its role has contracted versus newer regimens.

What do recent “trial updates” typically focus on?

• Biomarkers and resistance mechanisms (EGFR T790M era biology, C797S resistance, MET/ERBB2 bypass signaling, and liquid biopsy endpoints).
• Combination regimens where erlotinib is paired with chemotherapy, immunotherapy, or other targeted agents.
• Safety and exposure optimization in real-world cohorts and pharmacokinetic substudies.

What is the highest-probability pipeline outcome?

• Continued use in combination protocols and regional standard-of-care pockets.
• Incremental data supporting sequencing and tolerability rather than a new registration-grade claim that restarts exclusivity.

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Which patents protect erlotinib hydrochloride and what has the exclusivity timeline looked like?

Short answer: Erlotinib’s original discovery and early formulation/process patents drove the first wave of market exclusivity. Current commercial reality is dominated by generic entries and country-level patent term expirations. The principal remaining protection in many jurisdictions is typically limited to specific formulation/process or use claims that did not broadly block all generic pathways.

What is the likely patent estate status by claim type?

1. Active ingredient core compounds
   • Typically expired or near-expired in major markets given the drug’s approval history (mid-2000s).
2. Crystalline forms / salts
   • Erlotinib hydrochloride is a defined salt form; later patents, if any, are usually narrow (specific polymorphs/particle-size specs or manufacturing controls).
3. Formulations
   • Sustained-release or excipient/process dependent claims can linger, but they generally do not block immediate generic substitution unless the claims are unusually broad and actively litigated.
4. Method-of-use
   • Method-of-use patents are risk factors for “label expansion” claims but are rarely used to block generic entry after the original reference label has been established and global clinical practice evolves.

When does erlotinib lose exclusivity?

Because erlotinib is an established small molecule and major jurisdictions have moved well past the initial exclusivity window, the competitive inflection points are driven by:

• Patent term expirations of late-expiring formulation or process patents, if any remain in a specific country.
• Regulatory entry timing for generics (ANDAs already launched in most markets).
• Label and reimbursement rather than exclusivity.

Practical market effect: by now, “exclusivity loss” has largely already occurred; the main ongoing disputes (where they exist) are about residual IP rather than blocking the first generic launch.

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What is the Orange Book status of erlotinib hydrochloride and how many generic ANDAs are active?

Short answer: Erlotinib hydrochloride is widely available as generics. The Orange Book status is characterized by:

• Multiple approved ANDAs referencing Tarceva.
• Patent listings that may persist for specific formulations, but broad ingredient protection is no longer the gating factor in most jurisdictions.

Why Orange Book listings still matter for enforcement

Even if core active-ingredient protection is expired, lingering Orange Book-listed patents can:

• Create entry risk for certain generics if they cannot design around formulation or process claims.
• Drive settlement agreements tied to “carve-outs” (manufacturing changes, design-around strategies, label carve-outs).

Competitive implications

• Generic density is high, and market share is typically anchored by:
  • price,
  • availability and manufacturing reliability,
  • reimbursement formularies,
  • and local procurement patterns.

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How strong is the patent estate for erlotinib hydrochloride by jurisdiction?

Short answer: Generally weak for broad enforcement in major markets because primary IP from early development has long since expired. Remaining strength, if present, is usually narrow and localized to specific formulation/process parameters or method-of-use claims.

Litigation and settlement pattern (typical for mature small molecules)

For older oncology small molecules:

• Early disputes often involve generic design-around validity/coverage.
• Settlements typically allow generic entry on a defined schedule, sometimes with product/label constraints.

Business impact: most markets have already accepted generic competition. Current risk management centers on any still-active country-specific patents with live infringement exposure, not on blocking the existence of generics.

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What generic entry risks exist for erlotinib hydrochloride (ANDA Paragraph IV, design-around, and label risk)?

Short answer: For most geographies, the Paragraph IV decision is less about preventing generic entry and more about:

• avoiding narrow still-active patents (formulation/process),
• managing product specification compliance,
• and aligning to the permitted label.

Typical design-around axes

• Tablet/capsule composition differences within allowable bioequivalence bounds.
• Particle size and manufacturing process parameters affecting claimed compositions/processes.
• Specification changes that avoid infringing a listed formulation/process claim.

Label and method-of-use risk

• If a method-of-use patent is active in a specific market, an ANDA filer with an identical label may face risk.
• In practice, label carve-outs or different approved indications can mitigate risk, depending on local law.

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How do clinical endpoints and biomarker strategies affect erlotinib today?

Short answer: Erlotinib use is increasingly constrained by EGFR mutation biology and evolving sequencing standards. In markets where osimertinib became dominant for EGFR exon 19 deletion/L858R, erlotinib has shifted toward:

• post-progression lines,
• specific patient subsets,
• or settings with constrained access to next-generation TKIs.

What real-world evidence tends to show

• Variable response rates due to later-line use and resistance.
• Tolerability trade-offs (rash, diarrhea, liver enzyme elevations) driving dose adjustments and discontinuation.

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Erlotinib hydrochloride market analysis: where revenue is likely concentrated and what drives volume

Short answer: Commercial volume is driven by mature generic supply chains and country-level oncology purchasing patterns. Revenue is concentrated in markets with:

• sustained reimbursement for EGFR-targeted TKIs,
• hospital/clinic prescribing behavior favoring older EGFR TKIs,
• and pricing structures that keep generic use economically viable.

Market drivers by segment

1. NSCLC line-of-therapy position
   • Erlotinib is often second-line or later in current practice, especially where next-generation EGFR TKIs are available.
2. Pancreatic cancer regimen role
   • Erlotinib’s role is narrower than in its earlier era, with combination standards shifting.
3. Pricing and substitution
   • With many generics, price is a primary determinant of share. Supply reliability is a second-order driver.
4. Guideline and reimbursement alignment
   • Local formularies determine whether erlotinib remains a covered option after EGFR TKI sequencing evolves.

Revenue model (what matters more than “new trials”)

• Net price and contracted discounts.
• Dispensing volume (patients treated annually).
• Treatment duration on therapy in real practice.
• Hospital procurement and tender cadence.

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Market projection: how does erlotinib hydrochloride likely evolve through 2030?

Short answer: The base case is slow, mostly downward value growth (or flat revenue) with persistent unit-volume decline in regions where next-generation EGFR TKIs dominate first-line and where pancreatic standards continue moving away from older TKIs.

Projection drivers

• Therapy sequencing shift toward osimertinib and other newer agents for EGFR-mutated NSCLC.
• Regimen evolution in pancreatic cancer away from older gemcitabine plus TKI paradigms.
• Generic price pressure from high entry density.
• Geographic variability (emerging markets and constrained-access settings can sustain volume longer).

Competitive landscape and substitution risk

• Direct substitution by newer EGFR TKIs reduces the addressable NSCLC population for erlotinib over time.
• In markets where access limits newer agents, erlotinib can retain relevance, especially as an affordable oral option.

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How does erlotinib compare with other EGFR TKIs in competitive positioning?

Short answer: Erlotinib is a first-generation EGFR TKI. Competitive pressure is structurally higher from:

• osimertinib (often first-line in eligible EGFR-mutated NSCLC settings),
• earlier adoption of more effective EGFR TKIs,
• and combination strategies that reduce reliance on older TKIs.

Practical implications for commercial planning

• Brand value is typically eroded quickly once generics dominate.
• Product differentiation is minimal versus other TKIs in a class, so differentiation depends on:
  • cost,
  • supply continuity,
  • and formulary inclusion.

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What is the regulatory status of erlotinib hydrochloride (FDA approvals and labeling durability)?

Short answer: Erlotinib is FDA-approved and is marketed as Tarceva and by generics. Regulatory change activity is largely label maintenance rather than new approvals with major exclusivity impact.

Key regulatory practicalities

• Generics maintain approval through ANDA pathways referencing the reference listed drug (RLD).
• Ongoing regulatory relevance comes from:
  • bioequivalence updates,
  • quality manufacturing standards,
  • and label-driven clinical positioning.

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Key takeaways

• Erlotinib hydrochloride’s “clinical trials update” phase is largely incremental post-approval work focused on combinations and biomarker-resistance biology rather than restarting major late-stage registration potential.
• The patent estate that originally protected erlotinib is mostly expired in major jurisdictions; remaining protections, where any, tend to be narrow formulation/process or localized method-of-use claims.
• Market performance is driven primarily by generic price competition, reimbursement, and therapy sequencing, not by new exclusivity events.
• Base-case projection through 2030 is continued value pressure with variable unit-volume persistence in regions where newer EGFR TKIs are less accessible or not fully preferred in sequencing.

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FAQs

1) What is the most common real-world reason patients discontinue erlotinib?

Rash and gastrointestinal toxicities (diarrhea), followed by lab abnormalities that lead to dose reductions or discontinuation.

2) Does erlotinib still have a role in EGFR-mutated NSCLC?

Yes, mainly as a later-line option or in settings where newer agents are not used, guided by local sequencing and patient access.

3) Are there still active Paragraph IV challenges for erlotinib generics in the US?

Some challenges can occur for later-listed patents in specific listings, but broad entry blocking is unlikely given erlotinib’s maturity and extensive generic penetration.

4) How does erlotinib’s safety profile affect dosing strategy?

Clinicians commonly use dose reductions and interruption strategies to manage rash and diarrhea to maintain tolerability and adherence.

5) What’s the biggest commercial risk to erlotinib through 2030?

Continued displacement by newer EGFR TKIs in first-line sequencing and continued erosion of net price from high generic density.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Erlotinib Hydrochloride / Tarceva). U.S. Food and Drug Administration.
2. ClinicalTrials.gov. Erlotinib hydrochloride related studies (search results and registry entries). U.S. National Library of Medicine.
3. Prescribing information for Tarceva (erlotinib hydrochloride). U.S. Food and Drug Administration.