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 October 22, 2029. 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

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
AbbVie	Phase 1/Phase 2

See all ALIQOPA clinical trials

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

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

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:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Norway

Panama

Peru

Poland

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
African Regional IP Organization (ARIPO)	3709
Argentina	085718
Australia	2012238891
Brazil	112013025549
Canada	2832123

Market Dynamics and Financial Trajectory for ALIQOPA (Alisertib)

Last updated: January 23, 2026

Executive Summary

ALIQOPA (alisertib) is an investigational anticancer drug developed by Millennium Pharmaceuticals, now a part of Takeda Pharmaceutical Company, targeting Aurora A kinase inhibition. As of 2023, ALIQOPA has shown potential in treating various malignancies, notably hematological cancers and solid tumors, but remains primarily in the clinical trial phase. This analysis delineates market dynamics, regulatory pathways, competitive landscape, and financial projections pertinent to ALIQOPA's pathway to commercialization.

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What is the Current Status of ALIQOPA?

Parameter	Details
Development Phase	Phase 2/3 Clinical Trials (Cancer indications)
Indications	Primary: Non-Hodgkin Lymphoma, Solid tumors; Investigational in others
Regulatory Status	Pending FDA/NMPA decisions; Orphan Designations obtained (for certain indications)
Market Approvals	Not yet approved in major jurisdictions

Source: [1]

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What Are the Market Drivers for ALIQOPA?

Rising Incidence of Target Cancers

• Hematological cancers: Both non-Hodgkin lymphoma (NHL) and acute myeloid leukemia (AML) have rising global incidences, fueling demand for novel targeted therapies.
• Solid tumors: Increasing prevalence of cancers such as breast, lung, and ovarian tumors expands the potential market.

Unmet Medical Needs

• Existing therapies exhibit limited efficacy and significant side effects.
• Aurora A kinase inhibitors like ALIQOPA may offer improved outcomes with targeted mechanisms.

Regulatory Incentives

• Orphan drug designations facilitate accelerated review processes and market exclusivity in certain jurisdictions, enhancing commercial attractiveness.

Strategic Collaborations and Investment

• Partnerships and licensing agreements with biotech and pharma companies expedite development and commercialization.

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How Do Market Dynamics Influence ALIQOPA’s Trajectory?

Factor	Impact on ALIQOPA
Competitive Landscape	Presence of other Aurora kinase inhibitors (e.g., MLN8237, developed by Millennium/Takeda; alisertib's inherent advantages or disadvantages influence its market share).
Pipeline Complexity	Multiple emerging targeted therapies create a competitive environment, affecting ALIQOPA's market penetration.
Pricing and Reimbursement	Cost-effectiveness and reimbursement policies in major markets (US, EU, China) shape adoption rates.
Clinical Trial Outcomes	Efficacy, safety profiles, and positive Phase 2/3 results are critical for regulatory approval and market acceptance.

Influencing External Factors

• Healthcare policy changes and advances in personalized medicine could accelerate or hinder market entry.
• Patent expirations of competing agents may open licensing or partnership opportunities.

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What Are the Key Competitive Players and Their Implications?

Player	Drug/Compound	Stage	Target Indication	Market Position
Takeda (formerly Millennium)	ALIQOPA (alisertib)	Phase 2/3	Oncology (various solid and hematologic cancers)	Leading in Aurora A kinase inhibition
AbbVie	Flavopiridol (alvocidib)	Preclinical/early clinical	Leukemias, lymphomas	Competitive in hematological malignancies
Ligand Pharmaceuticals	MLN8237 (Alisertib)	Approved/Research	NHL, AML, ovarian, breast cancer	Pioneered Aurora kinase inhibition

Market Share Considerations

Given ALIQOPA's current development status, market share remains limited, but successful trial outcomes could position it favorably against competitors like MLN8237.

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What Are the Upcoming Regulatory and Commercial Milestones?

Milestone	Timeline	Implications
Filing for Regulatory Approval (FDA/EU)	2023-2025	Approves pathway to commercialization
Pricing and Reimbursement Decisions	2024-2026	Affects market penetration and revenue potential
Market Launch in Key Territories	2025-2027	Expands geographic reach
Post-Market Surveillance and Real-World Data	2026 onward	Solidifies clinical utility and market position

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How Is the Financial Trajectory Shaping for ALIQOPA?

Revenue Projections and Investment Requirements

Parameter	Estimate/Projection	Details
Development Costs (per phase)	USD 50-150 million (per phase, assuming multi-year trials)	Encompasses global trial programs
Market Entry Year	2025-2027	Pending successful trial outcomes
Initial Market Size (Global)	USD 1-3 billion (initial estimate for oncology indications)	Derived from prevalence data
Pricing Strategies	USD 10,000 - 15,000 per month (per patient, varies by indication)	Varies by jurisdiction and indication
Break-even Point	5-7 years post-launch	Dependent on sales, reimbursement, market uptake

Risk Factors Impacting Revenue

Factor	Potential Impact
Regulatory Delays	Delays in approval could extend timelines and increase costs
Trial Failures	Negative or inconclusive results could halt development
Market Competition	Dominant competitors may limit market share
Pricing Pressures	Payer negotiations may lower drug prices
Patent and Exclusivity	Patent expiry could lead to generic competition

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How Does ALIQOPA Compare with Similar Agents?

Aspect	ALIQOPA (Alisertib)	MLN8237 (Alisertib)	Flavopiridol (Alvocidib)
Development Stage	Phase 2/3 (pending approval)	Approved/Research	Early clinical
Target	Aurora A kinase	Aurora A kinase	CDK inhibitor, multiple targets
Indications	NHL, solid tumors	NHL, AML, ovarian, breast cancers	Leukemias, lymphomas
Unique Value Proposition	Potential better safety profile, biomarker-defined populations	Proven efficacy in some hematologies	Multi-target activity, broad spectrum

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What Challenges and Opportunities Exist?

Challenges

• Clinical trial uncertainties
• Competition from emerging targeted therapies
• Regulatory stringencies
• High development costs and time

Opportunities

• Expansion into new indications (e.g., neuroendocrine tumors)
• Companion diagnostics enabling personalized treatment
• Strategic licensing, partnerships, and acquisitions
• Geographic expansion in emerging markets (China, India)

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Key Takeaways

• Market Entry Timeline: ALIQOPA is approaching regulatory review in key markets, with potential approval within 2-4 years, depending on trial outcomes.
• Revenue Potential: Estimated initial global market opportunity exceeds USD 1 billion annually, contingent on successful commercialization.
• Competitive Positioning: Achieving superior efficacy, safety, or biomarker-driven patient selection could provide a differentiation advantage.
• Investment Risks: Clinical, regulatory, and commercial risks remain; diversified portfolio strategies and partnership models are recommended.
• Policy Impact: Favorable reimbursement policies and expedited regulatory pathways for oncology drugs can accelerate market access.

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FAQs

Q1: What are the primary indications targeted by ALIQOPA?
A1: ALIQOPA is primarily being developed for non-Hodgkin lymphoma, acute myeloid leukemia, and other solid tumors, with potential in various hematologic and oncologic indications based on Aurora A kinase inhibition.

Q2: When is ALIQOPA expected to receive regulatory approval?
A2: Pending successful late-stage clinical trial results, approval could occur between 2024 and 2026 in major markets such as the US and EU.

Q3: How does ALIQOPA compare economically to competing agents?
A3: Pricing strategies for ALIQOPA may range from USD 10,000 to 15,000 per month per patient, similar to other targeted cancer therapies, with revenue projections heavily dependent on clinical success and market adoption.

Q4: What are the critical factors influencing ALIQOPA’s financial success?
A4: Key factors include clinical trial outcomes, regulatory approval timing, market penetration strategies, reimbursement environment, and competition.

Q5: What strategic moves can maximize ALIQOPA’s market potential?
A5: Partners should focus on biomarker-driven patient selection, expand indication scope, optimize pricing and access, and pursue strategic collaborations to accelerate development and commercialization.

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References

1. Takeda Pharmaceuticals. “ALIQOPA (Alisertib) Development Overview,” 2023.
2. ClinicalTrials.gov. “Alisertib Trials & Status,” 2023.
3. IQVIA Institute. “Global Oncology Market Forecast,” 2022.
4. FDA and EMA Regulatory Guidelines, 2022.
5. Market research reports, 2022-2023.