ALIQOPA Drug Patent Profile

When do Aliqopa patents expire, and when can generic versions of Aliqopa launch?

Aliqopa is a drug marketed by Bayer Healthcare and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and five patent family members in forty-eight countries.

The generic ingredient in ALIQOPA is copanlisib dihydrochloride. Additional details are available on the copanlisib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Aliqopa

Aliqopa was eligible for patent challenges on September 14, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 29, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALIQOPA

International Patents:	105
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Drug Prices:	Drug price information for ALIQOPA
What excipients (inactive ingredients) are in ALIQOPA?	ALIQOPA excipients list
DailyMed Link:	ALIQOPA at DailyMed

See drug prices for ALIQOPA

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

Constraining patent/regulatory exclusivity:

10,383,876

NDA:

209936

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 ALIQOPA

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

Sponsor	Phase
NRG Oncology	Phase 2
City of Hope Medical Center	Phase 1/Phase 2
Dana-Farber Cancer Institute	Phase 1/Phase 2

See all ALIQOPA clinical trials

US Patents and Regulatory Information for ALIQOPA

ALIQOPA is protected by three US patents.

This potential generic entry date is based on patent 10,383,876.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,636,344
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No	RE46856		Y	Y
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No	10,383,876		Y	Y

Expired US Patents for ALIQOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017	7,511,041

International Patents for ALIQOPA

When does loss-of-exclusivity occur for ALIQOPA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ALIQOPA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2010511718
Panama	8759601
Chile	2013002870	Sal diclorhidrato de 2-amino-n-[7-metoxi-8-(3-morfolin-4-ilpropoxi)-2,3-dihidroimidazo[1,2-c]quinazolin-5-il]pirimidin-5-carboxamida; método de preparación; composición farmacéutica; combinación farmacéutica; y su uso para el tratamiento o profilaxis del cáncer.
Poland	226562

Market Dynamics and Financial Trajectory for Aliqopa (Copanlisib)

Last updated: July 27, 2025

Introduction
Aliqopa (copanlisib) represents a targeted therapy within the class of phosphoinositide 3-kinase (PI3K) inhibitors. Developed by Bayer AG, it received approval from the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of relapsed follicular lymphoma (FL), an indolent form of non-Hodgkin lymphoma. As a potent agent tailored for specific hematologic malignancies, its market dynamics and financial outlook are shaped by evolving clinical practices, regulatory landscapes, competitive pressures, and broader oncology drug market trends.

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Market Landscape and Therapeutic Positioning

Aliqopa operates within the competitive sphere of PI3K inhibitors, a class that includes drugs like Idelalisib (Zydelig), Duvelisib (Copiktra), and generally, novel agents targeting B-cell malignancies. Its distinct mechanism, predominantly inhibiting the alpha and delta isoforms of PI3K, offers a targeted approach tailored to lymphoma patients who have failed previous therapies.

The primary indication—relapsed follicular lymphoma—accounts for a significant segment of non-Hodgkin lymphoma cases globally, with an increasing incidence projected to drive demand. The therapeutic landscape for FL is characterized by multiple lines of therapy, notably chemoimmunotherapy and immunomodulatory treatments, with targeted agents like Aliqopa gaining prominence as options for relapsed or refractory disease.

Clinical Advantages and Challenges
Aliqopa's approval was based on a favorable side effect profile and effective response rates, with an overall response rate (ORR) of approximately 59% in relapsed FL patients as demonstrated in pivotal trials. The drug’s oral administration provides convenience over intravenous therapies, potentially influencing market adoption.

However, challenges persist. Competition from other PI3K inhibitors with established market presence, such as Idelalisib and Duvelisib, limits Aliqopa’s market penetration. Additionally, safety concerns associated with PI3K inhibitors, particularly immune-mediated adverse effects (colitis, pneumonitis, hepatotoxicity), necessitate careful patient selection and monitoring, possibly constraining broader use.

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Market Dynamics Shaping Aliqopa’s Trajectory

1. Regulatory and Reimbursement Environment
   Regulatory agencies prioritize safety profiles alongside efficacy in approving and expanding indications. Currently, Aliqopa has a Singulair indication. Future approvals for earlier lines of therapy or other lymphoma subtypes could broaden its market. Reimbursement policies in various regions influence prescribing behaviors, with payers favoring cost-effective, well-supported therapies.

2. Clinical Development and Label Expansion
   Bayer continues to explore Aliqopa's potential in combination regimens. Data from combination studies—such as with rituximab and other agents—may support label expansion, thereby unlocking sales growth. For instance, ongoing trials may demonstrate efficacy in chronic lymphocytic leukemia (CLL) or marginal zone lymphoma, diversifying its indications.

3. Competitive Dynamics
   The presence of established agents like Idelalisib, which has multiple approved indications and a longer market history, creates a significant barrier to rapid market expansion for Aliqopa. Nevertheless, its unique dosing schedule (bimonthly infusion versus more frequent dosing of competitors) may provide some differentiation.

4. Market Penetration and Adoption
   Despite its clinical benefits, Aliqopa's uptake has been gradual, influenced by clinicians’ familiarity with existing therapies, safety profile considerations, and prescriber preferences. Education initiatives and comparative efficacy data could influence broader adoption.

5. Pricing Strategy
   Pricing remains a critical lever. Although Bayer has positioned Aliqopa at comparable levels to rivals, potential discounts or value-based pricing strategies could impact revenues. Additionally, tiered pricing in emerging markets could open new revenue streams.

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Financial Trajectory and Revenue Outlook

Bayer’s sales of Aliqopa are modest relative to blockbuster oncology drugs, with estimates suggesting annual revenues in the range of $50-100 million globally as of 2022. Growth potential exists, driven by:

• Label Expansion: Additional approvals in frontline settings or other malignancies could stimulate revenue.
• Combination Therapies: Adoption in combination regimens, especially if trial data show superior efficacy, may increase sales.
• Geographical Expansion: Entry into emerging markets with high lymphoma incidence rates could provide substantial revenue growth.

However, the current financial trajectory faces headwinds:

• Competitive Pressure: Market share loss to more established or innovative agents.
• Safety Concerns: Reports of adverse events could impact prescriber confidence.
• Pricing Concerns: Payer negotiations and formulary placements impact revenue streams.

Projected sales for Aliqopa are expected to grow modestly at a compound annual growth rate (CAGR) of 3-5% over the next five years, contingent on expansion efforts and successful clinical trials.

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Strategic Outlook

To solidify its market position, Bayer must focus on multi-pronged strategies:

• Clinical Trials—Pursuing label expansion through robust Phase III studies in additional lymphoma subtypes or earlier lines of therapy.
• Combination Regimens—Developing and promoting data for combinations that demonstrate superior efficacy.
• Market Education—Enhancing clinician awareness regarding Aliqopa's safety and efficacy profile.
• Partnerships and Licensing—Collaborating with regional or global partners to accelerate penetration.

In parallel, Bayer’s ability to navigate regulatory hurdles, manage safety profiles, and adapt pricing strategies will substantially influence Aliqopa’s long-term financial success.

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Key Takeaways

• Growing Need for Targeted Therapies: The rising incidence of follicular lymphoma and expanded treatment options position Aliqopa to benefit from evolving therapeutic paradigms.
• Competitive & Safety Challenges: Existing PI3K inhibitors dominate the landscape; safety concerns remain a barrier to broader adoption.
• Potential for Market Expansion: Label expansions, combination therapies, and geographic growth are critical to increasing revenues.
• Financial Outlook: Moderate but steady revenue growth dictated by clinical development success, competitive positioning, and payer dynamics.
• Strategic Focus Needed: Investment in clinical trials, education, and strategic partnerships will be vital for maximizing Aliqopa’s market and financial potential.

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FAQs

1. What are the primary indications for Aliqopa?
   Aliqopa is approved primarily for relapsed follicular lymphoma in adult patients who have received at least two prior systemic therapies.

2. How does Aliqopa differ from other PI3K inhibitors?
   Unlike some PI3K inhibitors only targeting delta isoforms, Aliqopa inhibits both alpha and delta isoforms, potentially offering a broader therapeutic profile.

3. What are the main safety concerns associated with Aliqopa?
   Safety issues include immune-mediated adverse events such as colitis, pneumonitis, and hepatotoxicity, requiring careful monitoring and management.

4. Can Aliqopa be used in combination with other therapies?
   Yes, ongoing trials are evaluating Aliqopa in combination with agents like rituximab, which may enhance efficacy and expand indications.

5. What factors could influence the future market growth of Aliqopa?
   Factors include successful clinical trials leading to label expansion, increased clinician familiarity, competitive advances, safety management, and region-specific market entry strategies.

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References

[1] Bayer. “Aliqopa (copanlisib) US prescribing information.” 2017.
[2] FDA. “FDA approves copanlisib for relapsed follicular lymphoma.” 2017.
[3] MarketResearch.com. “Global Non-Hodgkin Lymphoma Market Analysis.” 2022.
[4] Bayer. “ClinicalTrials.gov Dataset for Aliqopa Trials.” 2023.
[5] EvaluatePharma. “Oncology Drug Market Forecast 2022-2027.” 2022.