Drugs in ATC Class L01EN

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Drugs in ATC Class: L01EN - Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors

Tradename	Generic Name
BALVERSA	erdafitinib
PEMAZYRE	pemigatinib
TRUSELTIQ	infigratinib phosphate

L01EN Market Analysis and Financial Projection

Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors represent a transformative class of targeted cancer therapies, with accelerating market growth and intense patent activity. The L01EN class under the ATC classification system includes agents like erdafitinib, pemigatinib, infigratinib, and futibatinib, which target FGFR mutations driving cancers such as urothelial carcinoma and cholangiocarcinoma. Here's an in-depth analysis of their market dynamics and intellectual property landscape:

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Market Growth Projections

The global FGFR inhibitor market was valued at $1.57 billion in 2024, with forecasts predicting a rise to $2.47 billion by 2031 at a 6.8% CAGR[3][8]. This growth is driven by:

• Rising FGFR-altered cancer diagnoses (e.g., 20% of urothelial carcinomas harbor FGFR mutations)[5].
• Accelerated FDA approvals, including erdafitinib’s 2019 clearance for metastatic bladder cancer[5].
• Expansion into Asian markets through collaborations between pharma giants and regional CROs[3].

Regional Dynamics:	Region	2024 Market Share	Key Growth Drivers
North America	48%	High cancer burden, streamlined approvals[3][8]
Europe	32%	Erdafitinib adoption post-EMA approval[8]
Asia-Pacific	15% (Fastest CAGR)	Rising healthcare investments[8]

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Patent Landscape & Innovation Trends

The FGFR inhibitor space has seen 707 patent applications targeting 71 entities between 2020–2023, with FGFR ranking third in covalent inhibitor filings[11]. Key developments include:

Dominant Therapeutic Strategies

1. Second-Generation Inhibitors: Compounds like PRN1371 and Janssen’s pyrazolopyridinones (WO 2019/101182A1) target gatekeeper mutations (e.g., FGFR3 V555L/M) to overcome resistance seen with first-gen drugs[4][7].
2. Covalent Irreversible Designs: Agents such as futibatinib form permanent bonds with FGFR kinases, improving selectivity and durability[5][11].

“Second-generation FGFR inhibitors may supersede reversible inhibitors in specific therapeutic areas due to their mutation-specific efficacy.” – Patent analysis on mutated FGFR targeting [4]

Key Patent Holders

• Incyte Corporation: Holds pivotal patents for pemigatinib (expiring 2033–2040)[14].
• Janssen Pharmaceutica: Leads in covalent inhibitor IP (e.g., WO 2019/101182A1)[4].
• Academic Institutions: Dana-Farber Cancer Institute ranks among top filers for novel FGFR modulators[11].

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Clinical & Regulatory Milestones

Drug	Approval Year	Indication	Notable Trials
Erdafitinib	2019	Metastatic urothelial carcinoma	BLC2001 (ORR=40%)[5]
Pemigatinib	2020	Cholangiocarcinoma	FIGHT-202[14]
Futibatinib	2023 (Pending)	FGFR2-fusion HCC	FOENIX-CCA2[8]

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Challenges & Opportunities

Barriers to Adoption

• Toxicity Profile: Hyperphosphatemia (58% incidence with erdafitinib)[5].
• Acquired Resistance: Gatekeeper mutations reduce drug efficacy[4][7].

Emerging Opportunities

• Combination Therapies: Pairing FGFR inhibitors with checkpoint inhibitors (e.g., pembrolizumab)[15].
• Biomarker-Driven Trials: Liquid biopsies for real-time FGFR alteration monitoring[8].

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Competitive Landscape

Top Players: Bayer, Pfizer, Incyte, and Janssen control ~65% of the market[3][8]. Pipeline Highlights:

• Phase III: TAS-120 (Taiho) for FGFR2-fusion gastric cancers[8].
• Preclinical: Pan-FGFR inhibitors with CNS penetration for glioma[16].

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Future Outlook

1. Market Expansion: Asia-Pacific to witness 85% revenue surge by 2031[8].
2. Personalized Medicine: Co-development of companion diagnostics (e.g., Foundation Medicine’s FGFR assays)[14].
3. Cost Reduction: Generics expected post-2035 as early patents expire[14].

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Key Takeaways:

• FGFR inhibitors are redefining treatment for genomically-selected cancers.
• Patent cliffs post-2035 will reshape market accessibility.
• Combinatorial approaches and toxicity management remain critical R&D foci.

FAQs:

1. Which cancers are FGFR inhibitors approved for?
   Bladder, cholangiocarcinoma, and myeloid/lymphoid neoplasms[5][14].
2. What drives FGFR inhibitor resistance?
   Gatekeeper mutations (e.g., V555L/M)[4].
3. How do covalent inhibitors improve efficacy?
   Irreversible binding reduces off-target effects[5][11].
4. Which region dominates FGFR sales?
   North America (48% share)[8].
5. When will generics enter the market?
   Post-2035, following pemigatinib’s patent expiry[14].

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Sources: [3][4][5][8][11][14]

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=L01EN&showdescription=yes
2. https://www.semanticscholar.org/paper/Fibroblast-growth-factor-receptor-inhibitors:-Marseglia-Lodola/4dd5979cadd73d1c6a8f3ef8a73e50dec1b04f34
3. https://www.businesswire.com/news/home/20210813005297/en/Global-Fibroblast-Growth-Factor-Receptor-Inhibitor-Drug-Market-to-2026---Opportunity-Clinical-Trials-Insights---ResearchAndMarkets.com
4. https://pubs.acs.org/doi/pdf/10.1021/acsmedchemlett.9b00427
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC6627960/
6. https://www.atccode.com/L01EN
7. https://pubchem.ncbi.nlm.nih.gov/patent/US-11628162-B2
8. https://www.qyresearch.com/reports/4664777/fgfr-inhibitor-drugs
9. https://www.marketresearchforecast.com/reports/air-traffic-control-atc-market-2839
10. https://www.wipo.int/en/web/patent-analytics
11. https://pubmed.ncbi.nlm.nih.gov/39219095/
12. https://www.promarketreports.com/reports/atc-market-589
13. https://www.drugpatentwatch.com/p/atc-class/L01A
14. https://www.drugs.com/availability/generic-pemazyre.html
15. https://patents.google.com/patent/US20220218703A1/en
16. https://patents.google.com/patent/WO2021089005A1/en