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Last Updated: December 22, 2024

ERLOTINIB HYDROCHLORIDE Drug Patent Profile


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When do Erlotinib Hydrochloride patents expire, and what generic alternatives are available?

Erlotinib Hydrochloride is a drug 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, and Zydus Pharms. and is included in thirteen NDAs.

The generic ingredient in ERLOTINIB HYDROCHLORIDE is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Erlotinib Hydrochloride

A generic version of ERLOTINIB HYDROCHLORIDE was approved as erlotinib hydrochloride by RISING on June 11th, 2014.

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Drug patent expirations by year for ERLOTINIB HYDROCHLORIDE
Recent Clinical Trials for ERLOTINIB HYDROCHLORIDE

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

SponsorPhase
State University of New York - Downstate Medical CenterPhase 1/Phase 2
China Medical University HospitalPhase 1/Phase 2
MedSIRPhase 2

See all ERLOTINIB HYDROCHLORIDE clinical trials

Pharmacology for ERLOTINIB HYDROCHLORIDE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for ERLOTINIB HYDROCHLORIDE
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
Sun Pharm ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 210300-003 Nov 5, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Shilpa ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 211960-002 Nov 5, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa Inc ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091059-001 Nov 9, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Shilpa ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 211960-003 Nov 5, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 211083-001 Jul 2, 2020 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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