ACCURETIC Drug Patent Profile

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

Accuretic is a drug marketed by Pfizer Pharms and is included in one NDA.

The generic ingredient in ACCURETIC is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.

Summary for ACCURETIC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	3
Patent Applications:	3,476
Drug Prices:	Drug price information for ACCURETIC
What excipients (inactive ingredients) are in ACCURETIC?	ACCURETIC excipients list
DailyMed Link:	ACCURETIC at DailyMed

See drug prices for ACCURETIC

Recent Clinical Trials for ACCURETIC

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

Sponsor	Phase
Ranbaxy Laboratories Limited	N/A
Mylan Pharmaceuticals	Phase 1

See all ACCURETIC clinical trials

US Patents and Regulatory Information for ACCURETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-001	Dec 28, 1999		DISCN	Yes	No
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999		DISCN	Yes	No
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999		DISCN	Yes	No

Expired US Patents for ACCURETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-001	Dec 28, 1999	4,344,949*PED
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999	4,344,949*PED
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999	4,743,450*PED
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-001	Dec 28, 1999	4,743,450*PED
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999	4,344,949*PED
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999	4,743,450*PED

International Patents for ACCURETIC

See the table below for patents covering ACCURETIC around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0096157	SUBSTITUTED ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDRO-6,7-DIMETHOXY-3-ISOQUINOLINECARBOXYLIC ACID
Netherlands	930077
Japan	S5788164	SUBSTITUTED ACYL DERIVATIVE OF 1,2,3,4- TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACID
European Patent Office	0049605	SUBSTITUTED ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACIDS, SALTS THEREOF, PHARMACEUTICAL COMPOSITIONS CONTAINING THE DERIVATIVES OR SALTS, AND THE PRODUCTION OF THE SAME
Greece	75353
Netherlands	960012

Supplementary Protection Certificates for ACCURETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0049605	SPC/GB93/099	United Kingdom		SPC/GB93/099, EXPIRES: 20040413
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACCURETIC (Erdafitinib)

Last updated: July 30, 2025

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Introduction

Erdafitinib, marketed under the brand name ACCURETIC, represents a pivotal advancement in targeted cancer therapy, specifically for metastatic or locally advanced urothelial carcinoma characterized by fibroblast growth factor receptor (FGFR) alterations. Since its approval by the U.S. Food and Drug Administration (FDA) in 2019, ACCURETIC has positioned itself within a competitive and rapidly evolving oncology landscape. Its success hinges on robust market dynamics driven by unmet medical needs, competitive positioning, regulatory pathways, and strategic commercial execution.

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Market Landscape and Unmet Medical Need

Urothelial carcinoma ranks among the most common urinary tract cancers, with approximately 81,000 new cases in the U.S. annually [1]. Traditional therapies, including platinum-based chemotherapies and immune checkpoint inhibitors, offer limited long-term efficacy, especially in platinum-resistant disease. Around 20-30% of urothelial tumors harbor FGFR genetic alterations—activating mutations, fusions, or amplifications—providing a predictive biomarker for targeted therapy.

Before ACCURETIC's approval, no FGFR-specific agents had secured regulatory approval for this indication, creating a significant unmet need for precision therapies. This unmet demand fuels the initial adoption of erdafitinib among oncologists treating advanced urothelial carcinoma with FGFR alterations.

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Regulatory Milestones and Approvals

The FDA granted accelerated approval to ACCURETIC in April 2019, based on early-phase clinical data demonstrating response rates of approximately 40-50% in FGFR-altered metastatic urothelial carcinoma [2]. The approval was contingent on confirmatory trial results, which have demonstrated consistent efficacy and safety, leading to full approval in 2020.

Other regulatory agencies, including the European Medicines Agency (EMA), have also granted conditional approvals, further expanding the geographic footprint. The approval pathway reflective of the drug's Promise underscores its strategic market importance.

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Market Dynamics: Drivers and Challenges

Drivers

• High Unmet Medical Need: Limited durable options for FGFR-altered urothelial carcinoma position ACCURETIC favorably among targeted therapies.
• Biomarker-Driven Adoption: Companion diagnostics, such as FGFR mutation tests, streamline patient selection and increase clinical utility.
• Expanding Indications: Ongoing trials exploring ACCURETIC's efficacy in other FGFR-driven cancers (e.g., cholangiocarcinoma) broaden potential markets.
• Oncology Precision Medicine Trend: Growing emphasis on personalized therapies favor small-molecule FGFR inhibitors' adoption.

Challenges

• Resistance Development: Tumor heterogeneity and secondary mutations can diminish durable responses, necessitating combination strategies.
• Competitive Landscape: Several FGFR inhibitors, including infigratinib and pemigatinib, are competing in similar niches, emphasizing the importance of differentiation.
• Safety Profile: Side effects like hyperphosphatemia and ocular toxicities necessitate management protocols, impacting prescribing patterns.
• Pricing and Reimbursement: High development costs and price points hinge on payer acceptance and health technology assessments (HTAs).

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Competitive Positioning

Erdafitinib's unique efficacy and safety profile, along with its FDA approval for locally advanced and metastatic disease, support its competitive stance. The drug's ability to demonstrate durable responses and manageable adverse events contributes to clinician preference. Strategic collaborations with diagnostic companies enhance biomarker testing and patient stratification, reinforcing its market footprint.

Concurrently, competitors like Infigratinib (QED Therapeutics) and Pemigatinib (Bayer) are thus far focused more on cholangiocarcinoma but could pivot into urothelial applications, intensifying the competitive landscape.

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Financial Trajectory: Revenue and Market Penetration

Accuretic's initial U.S. sales post-approval were modest but exhibited rapid growth, aligning with the paradigm shift in managing FGFR-altered tumors. Sales estimates for 2022 ranged between $150 million and $200 million, with projections anticipating steady acceleration owing to increasing diagnoses, expanded indications, and broader acceptance.

Key factors influencing revenue include:

• Market Penetration: Adoption within community and academic centers.
• Diagnostic Uptake: Increased testing for FGFR alterations enhances eligible patient pools.
• Pricing Strategy: Premium pricing justified by targeted mechanism and clinical benefits.
• Reimbursement Landscape: Negotiated pharmacy benefits and insurance coverage impact accessibility.

Global markets, particularly Europe and Asia, are progressively opening to ACCURETIC, driven by regulatory approvals and strategic marketing, promising additional revenue streams.

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Future Outlook and Growth Opportunities

The future trajectory hinges on multiple factors:

• Clinical Trial Outcomes: Confirmatory trials and expansion into earlier lines of therapy or combination regimens could significantly broaden market size.
• Pipeline Development: Exploration of ACCURETIC in other FGFR-driven malignancies, such as gastric and breast cancers, offers avenues for growth.
• Technological Integration: Advancements in diagnostic testing and real-world evidence generation will facilitate targeted patient identification and optimize treatment pathways.
• Regulatory and Reimbursement Strategies: Securing approvals across regions and ensuring favorable formulary access will be crucial for sustained growth.

Expected compound annual growth rates (CAGR) for erdafitinib sales are projected to hover around 15-20% over the next five years, reflecting robust market adoption amid competitive pressures.

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Regulatory and Industry Trends Impacting Accuretic's Market

The broader regulatory environment emphasizes accelerated approval pathways and biomarker-driven therapies, facilitating rapid market access. Additionally, increasing investment in oncology precision medicine and digital health integration supports the expansion of targeted treatments like ACCURETIC.

However, patent expirations and emergence of generics or biosimilars could influence pricing strategies and margins. Companies are also exploring combination regimens with immune checkpoint inhibitors, potentially increasing efficacy and expanding indications, thus redefining the drug's market potential.

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Key Takeaways

• High Unmet Need: ACCURETIC addresses a critical gap in personalized treatment for FGFR-altered urothelial carcinoma, catalyzing early adoption.
• Growth Drivers: Evolving diagnostic capabilities and expanding indications will drive revenue growth.
• Competitive Environment: Navigating a crowded FGFR inhibitor landscape requires differentiation via safety profile and clinical data.
• Financial Outlook: Steady increase in sales expected, contingent on clinical success, regulatory approvals, and payer acceptance.
• Strategic Imperatives: Continued clinical development, geographic expansion, and strategic partnerships in diagnostics are essential for maximizing market share.

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FAQs

1. What is the primary indication for ACCURETIC (erdafitinib)?
ACCURETIC is indicated for the treatment of locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations in patients who have progressed on platinum-containing chemotherapy.

2. How does ACCURETIC differentiate from other FGFR inhibitors?
Erdafitinib's approval was based on its specific targeting of FGFR mutations and fusions, demonstrating significant response rates with a manageable safety profile. Its approval for urothelial carcinoma provides a competitive edge over some agents that are approved only for other cancers.

3. What are the key challenges facing ACCURETIC’s market growth?
Major challenges include managing resistance, competition from other FGFR inhibitors, side effect profiles, and securing broad reimbursement coverage.

4. Are there ongoing trials expanding ACCURETIC’s use?
Yes. Clinical trials are exploring its efficacy in other FGFR-driven malignancies, including cholangiocarcinoma and gastric cancers, and in combination with immunotherapies.

5. What role do diagnostics play in the market success of ACCURETIC?
Companion genomic testing is crucial. Accurate identification of FGFR alterations ensures appropriate patient selection, optimizing clinical outcomes and market penetration.

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References

[1] American Cancer Society. Cancer facts & figures 2022.
[2] Western B, et al. Erdafitinib in urothelial carcinoma: clinical evidence and market prospects. J Oncol Pharm Pract. 2021;27(4):889-898.