Copanlisib dihydrochloride - Generic Drug Details

What are the generic sources for copanlisib dihydrochloride and what is the scope of patent protection?

Copanlisib dihydrochloride is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Copanlisib dihydrochloride has one hundred and five patent family members in forty-eight countries.

Summary for copanlisib dihydrochloride

International Patents:	105
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	71
DailyMed Link:	copanlisib dihydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for copanlisib dihydrochloride

Dosage:

POWDER;INTRAVENOUS

^*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 copanlisib dihydrochloride

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

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	PHASE1
VA Office of Research and Development	Phase 1/Phase 2
M.D. Anderson Cancer Center	Phase 2

See all copanlisib dihydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for copanlisib dihydrochloride

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for copanlisib dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No			Y	Y
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No			Y	Y

Expired US Patents for copanlisib dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017

International Patents for copanlisib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Portugal	2694508
Israel	198273	תולדות מותמרות של 3,2-דיהידרואימידאזו [2,1-c] קווינאזולין היעילים לטיפול באי סדרים הנובעים משגשוג-יתר ומחלות הקשורות עם התפתחות כלי דם חדשים (Substituted 2,3-dihydroimidazo[1,2-c] quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis)
European Patent Office	2508525
Poland	2694508

Market Dynamics and Financial Trajectory for Copanlisib Dihydrochloride

Last updated: February 16, 2026

Overview

Copanlisib dihydrochloride is an oral phosphoinositide 3-kinase (PI3K) inhibitor approved for treating relapsed follicular lymphoma and marginal zone lymphoma in adults. It is marketed by Bayer under the brand name Aliqopa. The drug is administered intravenously, targeting specific lymphomas resistant to prior lines of therapy.

Market Landscape

• Indication Scope: Approved indications include relapsed follicular lymphoma (FL) and marginal zone lymphoma (MZL). No other malignant lymphoid conditions are currently authorized, limiting market reach.
• Competitor Profile: The PI3K inhibitor landscape includes drugs such as idelalisib (Gilead), duvelisib (Secura), and alpelisib (Novartis). However, these are primarily indicated for different hematologic malignancies or solid tumors, giving copanlisib a niche in certain lymphomas.
• Market Penetration: As of 2023, sales primarily derive from the US market. Other regions await regulatory approval or have restricted use.
• Reimbursement and Pricing: List price in the US is approximately $90,000 per infusion cycle. Payer reimbursement depends on regional policies and formulary inclusion.

Market Drivers

• High Unmet Need: Resistant follicular lymphoma and marginal zone lymphoma cases have limited treatments, fostering demand for targeted therapies like copanlisib.
• Regulatory Milestones: FDA approval in 2017 provided a competitive edge, with subsequent EMA approval in 2018. Ongoing supplemental approvals could expand use.
• Clinical Data: Efficacy demonstrated in pivotal trials show durable responses, influencing physician prescribing behaviors.

Market Constraints

• Safety Profile: Adverse events include hyperglycemia, hypertension, diarrhea, and fatigue, which can limit tolerability and usage durations. This influences physician and patient acceptance.
• Administration Mode: Intravenous delivery may hinder widespread adoption compared to oral competitors, especially in outpatient settings.
• Pricing Pressure: High treatment costs face scrutiny from payers and healthcare systems emphasizing value-based care.

Financial Trajectory

• Revenue Trends: Bayer’s reported sales of Aliqopa remained modest, with approximately $70 million globally in 2022, primarily from the US. Year-over-year growth is limited but expected to improve with expanded indications and market access.
• Research & Development (R&D) Investment: Bayer has committed to ongoing R&D efforts to demonstrate efficacy in other lymphoma subtypes and solid tumors, potentially increasing future revenue streams.
• Pipeline Developments: Anticipated results from combination trials with immunotherapies aim to broaden therapeutic use and drive sales.
• Pricing and Market Access: An increase in market share hinges on pricing strategies and reimbursement negotiations, especially outside the US.

Regulatory and Competitive Outlook

• Bayer aims to expand indications via supplemental applications, possibly including combination therapies.
• Competitors may introduce next-generation PI3K inhibitors with improved safety profiles or oral formulations, intensifying competitive pressures.
• Approval prospects in Europe and Asia are uncertain, affecting overall market growth.

Conclusion

Copanlisib dihydrochloride is positioned within a niche hematologic oncology market. Growth prospects depend on clinical trial outcomes, regulatory approvals, and healthcare system adoption strategies. Current revenues remain limited but could increase with expanding indications and better market penetration.

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Key Takeaways

• The primary market for copanlisib is relapsed follicular lymphoma and marginal zone lymphoma in the US.
• The drug faces competition from other PI3K inhibitors with differing safety profiles and administration routes.
• Revenues are constrained by safety concerns, high cost, and administration mode, but ongoing trials and regulatory efforts could expand the market.
• Bayer's focus on combination therapies and new indications may unlock future sales potential.
• Market access and reimbursement policies will significantly influence financial growth.

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FAQs

1. What are the main barriers to market expansion for copanlisib?
Safety profile concerns, intravenous administration, high costs, and limited indications restrict broader adoption.

2. How does copanlisib compare to oral PI3K inhibitors?
It is administered intravenously, which may limit outpatient use compared to oral competitors, and it has a distinct safety profile emphasizing hyperglycemia and hypertension.

3. What regulatory milestones could influence copanlisib’s market growth?
Additional approvals for new indications or in new regions and positive results from combination therapy trials.

4. What is the role of pricing in copanlisib’s market performance?
Pricing impacts payer acceptance and reimbursement; high costs may restrict use without demonstrated value or negotiation.

5. Are there anticipated pipeline developments?
Yes, Bayer plans to pursue trials for combination therapies and new indications, potentially expanding therapeutic use.

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Sources

[1] Bayer Annual Report 2022, “Aliqopa sales figures.”
[2] FDA and EMA approvals for copanlisib, 2017–2018.
[3] Market data on hematologic lymphoma therapies, 2023.