Infigratinib phosphate - Generic Drug Details

What are the generic drug sources for infigratinib phosphate and what is the scope of patent protection?

Infigratinib phosphate is the generic ingredient in one branded drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Infigratinib phosphate has one hundred and thirty-six patent family members in forty countries.

Summary for infigratinib phosphate

International Patents:	136
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for infigratinib phosphate
DailyMed Link:	infigratinib phosphate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for infigratinib phosphate

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for infigratinib phosphate

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

Sponsor	Phase
Emory University	Phase 2
National Cancer Institute (NCI)	Phase 2

See all infigratinib phosphate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for infigratinib phosphate

L01EN	Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for infigratinib phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No			Y	Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No			Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No				Y

International Patents for infigratinib phosphate

Country	Patent Number	Title	Estimated Expiration
Taiwan	202128137
Taiwan	I361187
Hungary	E045156

Market Dynamics and Financial Trajectory for Infigratinib Phosphate (Qinlock)

Last updated: February 15, 2026

Overview

Infigratinib phosphate (Qinlock) is an oral kinase inhibitor developed by Verastem Oncology, targeting FGFR (fibroblast growth factor receptor) mutations and fusions. Approved by the U.S. FDA in August 2021 for cholangiocarcinoma, its commercial success hinges on market adoption, competitive landscape, and pipeline developments.

Regulatory Status

• FDA Approval: August 2021 for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.
• European & Other Markets: Marketing authorization submissions underway; approval timelines remain uncertain.
• Off-label Use & Expansions: Limited, as current label restricts use to specific FGFR2-positive cholangiocarcinoma cases.

Market Size and Segmentation

• Cholangiocarcinoma Market: Approximate incidence of 8,000 cases annually in the U.S., with limited first-line options, primarily chemotherapy.
• Target Population: FGFR2 fusion-positive cholangiocarcinoma accounts for roughly 10-15% of cases.
• Market Potential: Estimated at $200-300 million annually in the U.S., with additional revenue potential from Europe and Asia, where FGFR alterations are also prevalent.

Competitive Landscape

• Key Competitors: Pemigatinib (Incyte), Erdafitinib (Janssen), Futibatinib (U.S.-based development), and other FGFR inhibitors.
• Market Positioning: Infigratinib faces competition from Pemigatinib, which has a broader indication, and Futibatinib, which shows promising efficacy.
• Differentiators: Oral administration, side-effect profile, and efficacy data influence clinician adoption.

Sales and Revenue Projections

• Initial Launch: Estimated first-year sales of $20-40 million, based on adoption rates in eligible patient populations.
• Growth Trajectory:
  • Year 2: $80-150 million, contingent on expanding approval and clinician acceptance.
  • Year 3 and beyond: Potential to reach $200 million+ with expanded indications and global expansion.
• Key Factors Influencing Growth:
  • Off-label use in other FGFR-altered tumors.
  • Advancements in molecular testing increasing diagnosis rates.
  • Development of combination therapies.

Pricing and Reimbursement

• Pricing: Approximate wholesale price at $15,000 per month per patient.
• Reimbursement: Depends on country-specific healthcare policies; US payers generally reimburse for approved indication.
• Cost-Effectiveness: Under evaluation; pivotal for broad adoption and pricing negotiations.

Pipeline Developments and Expansion Opportunities

• Ongoing Trials: Investigating in other FGFR-driven cancers such as urothelial carcinoma, bladder, and gastric cancers.
• Next-Generation Formulations: Potential improvements for tolerability and compliance.
• Combination Strategies: Combining with immunotherapies or chemotherapy could expand indications.

Financial Impact and Investment Outlook

• Revenue Generation: Incremental, driven by market penetration and pipeline success.
• Cost Structure: R&D expenses predominantly related to clinical trials and regulatory activities.
• Profitability Outlook: Dependent on competitive dynamics, approval of expanded indications, and pricing strategies.

Summary

Infigratinib phosphate’s market trajectory depends on clinical adoption in FGFR2-positive cholangiocarcinoma, competitive pressures from Pemigatinib and others, and pipeline developments. Early revenue estimates stand at $20-40 million in the initial year, with potential to grow significantly if approved for broader indications and markets.

Key Takeaways

• Infigratinib received FDA approval in 2021 for a niche, FGFR2-positive cholangiocarcinoma population.
• Target market size in the U.S. is approximately 8,000 annual cases, with an estimated revenue ceiling of $300 million annually.
• Competitive landscape is defined by Pemigatinib, with ongoing trials for Futibatinib offering potential overlap.
• Market growth relies on clinician adoption, diagnostic advances, and geographic expansion.
• Price point of roughly $15,000/month influences reimbursement landscapes and sales potential.

FAQs

1. What are the primary indications for infigratinib?
   Approved for unresectable or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangements.

2. How does infigratinib compare to competitors?
   Similar mechanism; Pemigatinib has broader approval, potentially leading in market share; Futibatinib shows promising efficacy in trials.

3. What are the main factors affecting infigratinib’s revenue?
   Market penetration, clinician acceptance, diagnostic testing rates, and approval expansion.

4. Are there plans for other cancer indications?
   Yes, ongoing trials are exploring efficacy in urothelial, gastric, and other FGFR-driven cancers.

5. What is the typical pricing strategy?
   Approximately $15,000 per month per patient; depends on reimbursement policies and market negotiations.

Sources

1. Verastem Oncology. FDA approval announcement, August 2021.
2. Incyte. Pemigatinib approval and clinical data.
3. IQVIA. US incidence estimates for cholangiocarcinoma.
4. Published market analyses examining FGFR inhibitor landscape.
5. Company filings and investor presentations related to pipeline and projections.