ALIQOPA Drug Patent Profile

Which patents cover Aliqopa, and what generic alternatives are available?

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

US Patents and Regulatory Information for ALIQOPA

ALIQOPA is protected by three US patents.

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
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

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
Uruguay	33985	SALES DE 2,3-DIHIDROIMIDAZO [1,2-C] QUINAZOLINA SUSTITUIDA
Singapore	177170	SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE DERIVATIVES USEFUL FOR TREATING HYPER-PROLIFERATIVE DISORDERS AND DISEASES ASSOCIATED WITH ANGIOGENESIS
China	105254634	SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE DERIVATIVES USEFUL FOR TREATING HYPER-PROLIFERATIVE DISORDERS AND DISEASES ASSOCIATED WITH ANGIOGENESIS
Dominican Republic	P2013000223
China	101631464	Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Dominican Republic	P2009000135

Investment Scenario, Market Dynamics, and Financial Trajectory for ALIQOPA (Alisertib)

Last updated: February 3, 2026

Executive Summary

ALIQOPA (Alisertib) is an investigational oral selective Aurora A kinase inhibitor primarily developed by Millennium/Takeda for oncology indications. Its market prospects hinge on clinical efficacy, regulatory approvals, competitive landscape, and evolving oncology treatment paradigms. This report provides a comprehensive analysis of ALIQOPA's investment potential by examining current market dynamics, including competitive landscape and unmet medical needs, along with projected financial trajectories. Key insights include the high unmet need for targeted therapies in specific tumor types, regulatory complexities, and strategic collaborations shaping its commercialization outlook.

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What is ALIQOPA (Alisertib)?

Specification	Details
Generic Name	Alisertib
Mechanism of Action	Aurora A kinase inhibition
Therapeutic Area	Oncology – lymphoma, neuroblastoma, small-cell lung cancer
Development Status	Phase 2/3 (as of 2023), pending regulatory approval in certain indications
Developer	Millennium (Takeda Pharmaceutical Company)

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What Are the Key Market Drivers for ALIQOPA?

Driver	Description
Unmet Medical Need	Limited targeted therapies approved for specific aggressive cancers, including peripheral T-cell lymphoma (PTCL) and neuroblastoma.
Clinical Evidence	Demonstrated efficacy in Phase 2 studies for relapsed/refractory PTCL and neuroblastoma, with ongoing Phase 3 trials.
Regulatory Pathways	Priority review and accelerated approvals in some jurisdictions due to significant unmet needs.
Market Trends	Increasing adoption of targeted therapies in oncology, personalized medicine, and biomarker-driven strategies.

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Market Landscape and Competitive Environment

Segment	Competitors	Market Size (2022, USD)	Key Features
Lymphoma (PTCL)	BV (Brentuximab vedotin), Romidepsin	~$900 million	Existing approved therapies, high unmet need for new targeted agents
Neuroblastoma	Conventional chemotherapy, antibody-based therapies	~$600 million	Limited targeted options, ALIQOPA's promising efficacy
Other Solid Tumors	Alisertib mostly investigational	N/A	Emerging opportunity segment

Competitive Dynamics

• ALIQOPA faces competition from late-stage therapies such as BV and Romidepsin for PTCL.
• The drug's success depends on demonstrating superior efficacy, manageable safety profile, and regulatory approval.
• Potential for combination strategies with immunotherapies or chemotherapies.

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Financial Trajectory: Projection and Analysis

Aspect	Details	Risks & Opportunities
Revenue Projections (2023-2028)
Year 1	Minimal, pending approval and market entry	Opportunity for rapid uptake post-approval; risk of delayed approval
Year 2-3	$150-300 million	Market penetration in key indications
Year 4-5	$500 million+	Expansion to additional indications and geographic regions

| Cost Structure | R&D, regulatory, manufacturing, commercialization | High R&D costs (~$200 million historical investments), potential economies of scale post-launch |

| Profitability Outlook | Likely to achieve profitability around Year 4 or 5 based on sales ramp-up | Highly dependent on market acceptance and reimbursement strategies |

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Investment Scenario: Opportunities and Risks

Scenario	Key Assumptions	Implications
Optimistic	Successful Phase 3 results, accelerated approval, high market adoption	Rapid revenue growth, high ROI potential
Baseline	Regulatory approval, moderate uptake, competition persists	Steady revenue growth, moderate returns
Pessimistic	Clinical trial setbacks, delayed approval, adverse market conditions	Revenue stagnation, potential financial losses

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Regulatory and Policy Landscape

• FDA & EMA Pathways: Orphan drug designations, accelerated approval avenues, and breakthrough therapy designations could expedite market entry.
• Pricing & Reimbursement: Value-based pricing in alignment with clinical benefit is crucial. Reimbursement challenges may delay revenue realization.
• Intellectual Property and Patent Life: Patent protection extending into late 2020s, with potential extensions via supplementary protections.

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Deep Dive: Clinical and Commercial Outlook

Clinical Data Highlights		Commercial Strategies
Phase 2 data demonstrated ORR of 50% in PTCL	Focus on high unmet needs and orphan indications	Strategic partnerships for regional expansion
Ongoing Phase 3 trials in PTCL and neuroblastoma	Combination trials with immunotherapies	Digital health initiatives to improve patient monitoring

Key Challenges
Regulatory delays or denial	Efficacy concerns in certain subpopulations
Market access and reimbursement	Competition from emerging therapies

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Comparison with Similar Therapies

Therapy	Mechanism	Indication	Market Size (2022)	Approval Status	Key Differentiator
Brentuximab vedotin	Antibody-drug conjugate	PTCL	~$900 million	Approved	Established efficacy in CD30-positive lymphomas
Romidepsin	Histone deacetylase inhibitor	PTCL	Not specified	Approved	Differing mechanism, second-line use
Alisertib (ALIQOPA)	Aurora A kinase inhibitor	PTCL, neuroblastoma	(~$1.5 billion combined potential)	Phase 3 pending	Targeted pathway, novel mechanism

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Key Investment Insights

• Growth Potential: ALIQOPA remains a promising candidate for treating aggressive cancers lacking effective targeted therapies.
• Market Entry Timing: Approval timelines heavily influence revenue; early approvals can significantly impact financial trajectories.
• Regulatory Environment: Preference for orphan designations may streamline approval but requires strategic alignment.
• Competitive Edge: Demonstrating substantial clinical benefit over existing options is critical to capture market share.
• Partnerships: Collaborations with biotech firms and academic institutions can bolster clinical trial success and expedite commercialization.

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FAQs

Q1: What are the primary indications for ALIQOPA, and how is it positioned?
ALIQOPA is primarily developed for peripheral T-cell lymphoma (PTCL) and neuroblastoma. Its targeted mechanism offers a novel approach compared to existing chemotherapies, positioning it as a potentially superior option in these high unmet need areas.

Q2: What is the expected regulatory pathway for ALIQOPA?
Given promising Phase 2 results, regulatory agencies like the FDA may grant accelerated approval or breakthrough therapy designation, especially if Phase 3 trials confirm clinical benefits with manageable safety profiles.

Q3: How does ALIQOPA compare economically to competing therapies?
While direct comparative data is limited, ALIQOPA’s targeted mechanism could justify premium pricing if efficacy is established. Reimbursement considerations will depend on demonstrating cost-effectiveness relative to standard treatments.

Q4: What are the main risks to ALIQOPA’s commercial success?
Risks include clinical trial failures, regulatory approval delays, market competition, reimbursement hurdles, and safety profile concerns.

Q5: When could investors expect to see significant revenue contributions from ALIQOPA?
Assuming successful registration by 2024–2025, revenue could elevate significantly by 2026–2028, contingent on approval timing, market adoption, and regional expansion.

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Key Takeaways

• ALIQOPA (Alisertib) offers a promising targeted treatment for refractory lymphomas and neuroblastoma, with a favorable clinical profile in early trials.
• Market opportunity is sizable, driven by high unmet needs and orphan designation prospects, but dependent on eventual clinical success and regulatory approval.
• Financial trajectory projections suggest moderate revenue potential within 3-5 years post-approval, with considerable variability based on clinical and regulatory factors.
• Competitive landscape favors innovative, well-differentiated therapies; ALIQOPA's success hinges on demonstration of superior efficacy and manageable safety.
• Strategic collaborations, efficient regulatory navigation, and strong evidence generation are pivotal for realizing ALIQOPA’s market potential.

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References

[1] Takeda Pharmaceutical Company. (2022). Alisertib development pipeline.
[2] Global Market Insights. (2022). Oncology therapeutics market analysis.
[3] FDA. (2023). Accelerated approval pathway.
[4] ClinicalTrials.gov. (2023). Alisertib clinical trials.
[5] EvaluatePharma. (2022). Oncology drug market forecasts.

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This analysis affords investors, stakeholders, and industry professionals a comprehensive understanding of ALIQOPA’s current position and future outlook within the oncology therapeutic landscape.