ERLOTINIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for erlotinib hydrochloride and what is the scope of freedom to operate?

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. Thirteen 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:	13
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	833
Patent Applications:	19
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
State University of New York - Downstate Medical Center	Phase 1/Phase 2
China Medical University Hospital	Phase 1/Phase 2
MedSIR	Phase 2

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
Chartwell Rx	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	203843-001	Sep 13, 2024	AB	RX	No	No
Rising	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	091002-003	Jun 11, 2014	AB	RX	No	No
Natco Pharma Ltd	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	208488-001	Nov 5, 2019		DISCN	No	No
Msn	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	214366-001	May 10, 2021	AB	RX	No	No
Alembic	ERLOTINIB HYDROCHLORIDE	erlotinib hydrochloride	TABLET;ORAL	214719-001	Jul 8, 2021	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	7,087,613*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004	5,747,498*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004	7,087,613*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004	6,900,221*PED
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004	RE41065*PED

ERLOTINIB HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Erlotinib Hydrochloride

Introduction

Erlotinib hydrochloride, marketed under the brand name Tarceva among others, is a tyrosine kinase inhibitor used primarily in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. This article delves into the market dynamics and financial trajectory of erlotinib hydrochloride, highlighting key drivers, restraints, and future opportunities.

Market Size and Growth

The global market for erlotinib hydrochloride is anticipated to experience significant growth. By 2030, the market is expected to reach a substantial value, driven by an increasing prevalence of cancer and advancements in healthcare technologies[3][4].

Key Players

The market is dominated by several key players, including HEC Pharm, Arasto Pharmaceutical Chemicals Inc., Tava, Polpharma Pharmaceutical Works, Suanfarma, Natco Pharma, Tecoland, Shanghai Biosundrug Co., Ltd., and Shilpa Medicare Ltd. These companies are investing heavily in research and development to enhance the efficacy and safety of erlotinib hydrochloride[1][4].

Market Segmentation

The erlotinib hydrochloride market is segmented based on indication and region. The primary indications include non-small cell lung cancer (NSCLC), pancreatic cancer, and other types of cancer. Geographically, the market is segmented into North America, Europe, Asia-Pacific, and LAMEA (Latin America, Middle East, and Africa)[4].

Types of Erlotinib Hydrochloride

Erlotinib hydrochloride is available in various tablet strengths, including 25 mg, 100 mg, and 150 mg. These different formulations cater to the diverse needs of patients and healthcare providers[1].

Cost-Effectiveness

Economic analyses have shown that first-line treatment with erlotinib is cost-effective compared to standard chemotherapy for patients with EGFR-mutated NSCLC. In a European study, erlotinib treatment was found to be cost-saving and yielded a gain in quality-adjusted life-years. This cost-effectiveness is a significant driver for the adoption of erlotinib hydrochloride in clinical practice[2].

Drivers of Market Growth

Several factors are driving the growth of the erlotinib hydrochloride market:

• Increasing Prevalence of Cancer: The rising incidence of cancer, particularly NSCLC and pancreatic cancer, is a major driver.
• Advancements in Healthcare: Improvements in diagnostic techniques and treatment options are increasing the demand for targeted therapies like erlotinib hydrochloride.
• Research and Development: Continuous investments in R&D are enhancing the drug's efficacy and safety, making it a preferred choice for healthcare providers[4].

Restraints

Despite the growth potential, there are several restraints affecting the market:

• Side Effects: Erlotinib hydrochloride is associated with side effects such as stomach upset, vomiting, loss of appetite, weight loss, diarrhea, and mouth sores, which can limit its adoption.
• Competition: The presence of other tyrosine kinase inhibitors and emerging therapies can pose a competitive challenge to erlotinib hydrochloride[4].

Future Opportunities

The market for erlotinib hydrochloride presents several future opportunities:

• Exploiting Full Potential: Ongoing research and development aimed at maximizing the drug's potential can lead to new indications and improved formulations.
• Emerging Markets: Expanding into new geographic regions, particularly in Asia-Pacific and LAMEA, offers significant growth potential[4].

Financial Trajectory

The financial trajectory of erlotinib hydrochloride is promising, with the global market size expected to reach approximately USD 2.8 billion by 2032. This growth is driven by increasing demand, improved healthcare infrastructure, and continuous innovation in the pharmaceutical sector[3].

Competitive Landscape

The competitive landscape is characterized by intense competition among key players. Companies are focusing on strategic partnerships, mergers and acquisitions, and robust R&D activities to maintain their market share. For instance, Roche Holding AG, one of the key players, is known for its strong research capabilities and global presence[4].

Economic Impact

The economic impact of erlotinib hydrochloride is significant, particularly in terms of cost-effectiveness and quality-adjusted life-years. A study indicated that, given a willingness to pay at least €90,000 for one quality-adjusted life-year, the probability that first-line erlotinib would be cost-effective was very high in several European countries[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of erlotinib hydrochloride. Regulatory approvals and compliance with stringent safety and efficacy standards are essential for the drug's continued market presence. Companies must navigate complex regulatory landscapes to ensure their products remain approved and accessible to patients[4].

Patient Impact

Erlotinib hydrochloride has a significant impact on patient outcomes, particularly in terms of survival rates and quality of life. By blocking the tyrosine kinase receptor and inhibiting the epidermal growth factor receptor (EGFR), the drug helps in controlling the growth of cancer cells. This targeted approach often results in better patient outcomes compared to traditional chemotherapy[4].

Conclusion

The market for erlotinib hydrochloride is poised for significant growth, driven by increasing cancer prevalence, advancements in healthcare, and continuous R&D. While side effects and competition pose challenges, the drug's cost-effectiveness and potential for new indications make it a valuable asset in the fight against cancer.

Key Takeaways

• Market Growth: The global erlotinib hydrochloride market is expected to reach USD 2.8 billion by 2032.
• Key Players: HEC Pharm, Arasto Pharmaceutical Chemicals Inc., Tava, Polpharma Pharmaceutical Works, and others dominate the market.
• Cost-Effectiveness: Erlotinib hydrochloride is cost-effective compared to standard chemotherapy for EGFR-mutated NSCLC.
• Drivers and Restraints: Increasing cancer prevalence and R&D investments drive growth, while side effects and competition are restraints.
• Future Opportunities: Expanding into new regions and maximizing the drug's potential through R&D.

FAQs

Q1: What are the primary indications for erlotinib hydrochloride?

• The primary indications for erlotinib hydrochloride include non-small cell lung cancer (NSCLC) and pancreatic cancer.

Q2: Who are the key players in the erlotinib hydrochloride market?

• Key players include HEC Pharm, Arasto Pharmaceutical Chemicals Inc., Tava, Polpharma Pharmaceutical Works, Suanfarma, Natco Pharma, Tecoland, Shanghai Biosundrug Co., Ltd., and Shilpa Medicare Ltd.

Q3: What are the different types of erlotinib hydrochloride available?

• Erlotinib hydrochloride is available in 25 mg, 100 mg, and 150 mg tablet strengths.

Q4: Is erlotinib hydrochloride cost-effective compared to standard chemotherapy?

• Yes, erlotinib hydrochloride has been shown to be cost-effective and yield a gain in quality-adjusted life-years compared to standard chemotherapy for EGFR-mutated NSCLC.

Q5: What are the future opportunities for the erlotinib hydrochloride market?

• Future opportunities include expanding into new geographic regions, maximizing the drug's potential through R&D, and exploring new indications.

Sources

1. Global Erlotinib Hydrochloride Market Research Report 2024 - Valuates Reports
2. Economic Analysis of First-Line Treatment with Erlotinib in an EGFR-Mutated Advanced-Stage Non-Small Cell Lung Cancer - PubMed
3. Global Exeter Erlotinib Hydrochloride Tablet Market Research Report 2032 - DataIntelo
4. Exeter Erlotinib hydrochloride tablet Market - Allied Market Research
5. Daiichi Sankyo Group Value Report 2017 - Daiichi Sankyo Group