Erlotinib,Markets and News,API,Erlotinib hydrochloride,183319-69-9,ANQING CHICO PHARMACEUTICAL
Abstract
Erlotinib hydrochloride, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, revolutionized targeted therapy for non-small cell lung cancer (NSCLC) and pancreatic cancer. Approved in 2004 by the FDA, it became a cornerstone of EGFR-mutated NSCLC treatment. However, global sales have declined steadily due to generic competition and newer-generation therapies. This paper reviews erlotinib’s chemical properties, development history, market trajectory, and competitive landscape, with speculative sales projections from 2020 to 2024.
Keywords: Erlotinib, EGFR inhibitor, NSCLC, Tyrosine kinase inhibitor, Generic competition
Introduction
Non-small cell lung cancer (NSCLC), accounting for 85% of lung cancer cases, has seen significant advancements in targeted therapies. Erlotinib hydrochloride, developed to inhibit EGFR tyrosine kinase activity, emerged as a breakthrough for patients with EGFR mutations. Despite its clinical success, market dynamics shifted with patent expiries, generics, and next-generation inhibitors. This paper explores erlotinib’s scientific and commercial journey, highlighting its impact and challenges.
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1. Chemical Properties
Erlotinib hydrochloride (CAS 183319-69-9) is a quinazoline derivative with the molecular formula C22H23N3O4⋅HClC22H23N3O4⋅HCl. It appears as a white to pale-yellow powder, soluble in dimethyl sulfoxide (DMSO) and slightly soluble in water. Its mechanism involves reversible inhibition of EGFR tyrosine kinase, blocking tumor cell proliferation.
2. Development and Approval
Original Manufacturers: Jointly developed by OSI Pharmaceuticals, Genentech, and Roche.
Approval Timeline: FDA approval for NSCLC (2004) and pancreatic cancer (2005); EMA approval followed in 2005.
3. Market Entry and Global Sales
Peak sales reached ~$1.5 billion in 2013 under Roche’s brand name Tarceva®. However, generics entered key markets post-patent expiry:
2016: U.S. generics launched after patent litigation resolved.
2010–2012: Early generics in India and emerging markets.
Sales declined annually, dropping to ~$900 million by 2019.
4. Market Competition
Direct Competitors: Gefitinib (AstraZeneca), afatinib (Boehringer Ingelheim), and osimertinib (3rd-gen EGFR inhibitor).
Newer Therapies: Osimertinib’s superior efficacy in EGFR T790M-mutated NSCLC eroded erlotinib’s market share.
5. Generics Impact
Generic versions (e.g., Cipla, Teva) reduced prices by 70–80%, accelerating revenue decline. By 2020. generics held >60% of the global erlotinib market.
6. Sales Projections (2020–2024)
Based on historical trends and generic saturation, annual declines of ~12–15% are projected:
2020: $800 million
2021: $700 million
2022: $600 million
2023: $500 million
2024: $400 million
(These estimated figures reflect the decline in sales of the branded product amid rising generic competition and pricing pressures.)
7. Recent Developments
Combination Therapies: Trials exploring erlotinib with anti-angiogenic agents (e.g., bevacizumab).
Off-Patent Status: Roche discontinued active promotion, focusing on novel oncology pipelines.
References
U.S. FDA. (2004). Tarceva® Approval Letter.
Roche Annual Reports (2013–2019).
DrugBank. (2023). Erlotinib Hydrochloride.
EMA. (2005). Tarceva® European Assessment Report.
Generics Bulletin. (2016). U.S. Generic Erlotinib Launches.
GlobalData. (2022). NSCLC Targeted Therapy Market Analysis.
Note: Sales figures are estimates based on historical data, generic entry timelines, and market analysis. Actual numbers may vary due to regional pricing and regulatory factors.
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Erlotinib hydrochloride,183319-69-9
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