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 four patents protecting this drug.

This drug has one hundred and fifty-four patent family members in fifty countries.

The generic ingredient in ALIQOPA is copanlisib dihydrochloride. One supplier is listed for this compound. 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:	154
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Patent Applications:	532
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

Pharmacology for ALIQOPA

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

US Patents and Regulatory Information for ALIQOPA

ALIQOPA is protected by four US patents and one FDA Regulatory Exclusivity.

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	7,511,041		Y	Y
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
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No

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

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
China	101631464	Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Ukraine	96965	ЗАМЕЩЕННЫЕ ПРОИЗВОДНЫЕ 2,3-ДИГИДРОИМИДАЗО[1,2-с]ХИНАЗОЛИНА, ПОЛЕЗНЫЕ ДЛЯ ЛЕЧЕНИЯ ГИПЕРПРОЛИФЕРАТИВНЫХ НАРУШЕНИЙ И БОЛЕЗНЕЙ, СВЯЗАННЫХ С АНГИОГЕНЕЗОМ;ЗАМІЩЕНІ ПОХІДНІ 2,3-ДИГІДРОІМІДАЗО[1,2-с]ХІНАЗОЛІНУ, КОРИСНІ ДЛЯ ЛІКУВАННЯ ГІПЕРПРОЛІФЕРАТИВНИХ ПОРУШЕНЬ ТА ХВОРОБ, ПОВ'ЯЗАНИХ З АНГІОГЕНЕЗОМ (2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE SUBSTITUTED DERIVATIVES USEFUL FOR TREATING HYPER-PROLIFERATIVE AND ANGIOGENESIS DISORDERS)
Cyprus	1116231
Eurasian Patent Organization	018839	ЗАМЕЩЕННЫЕ ПРОИЗВОДНЫЕ 2,3-ДИГИДРОИМИДАЗО[1,2-С]ХИНАЗОЛИНА, ПОЛЕЗНЫЕ ДЛЯ ЛЕЧЕНИЯ ГИПЕРПРОЛИФЕРАТИВНЫХ НАРУШЕНИЙ И БОЛЕЗНЕЙ, СВЯЗАННЫХ С АНГИОГЕНЕЗОМ (SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE DERIVATIVES USEFUL FOR TREATING HYPER-PROLIFERATIVE DISORDERS AND DISEASES ASSOCIATED WITH ANGIOGENESIS)
Poland	375935	Pochodne skondensowanych azolopirymidyn (FUSED AZOLE-PYRIMIDINE DERIVATIVES)
Japan	4790266

ALIQOPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aliqopa

Introduction

Aliqopa, marketed under the generic name copanlisib, is a kinase inhibitor specifically designed for the treatment of follicular lymphoma, a type of non-Hodgkin lymphoma. Here, we delve into the market dynamics and financial trajectory of Aliqopa, highlighting key aspects such as its mechanism of action, market assessments, and future projections.

Mechanism of Action and Clinical Use

Aliqopa is a PI3K inhibitor, targeting the phosphatidylinositol 3-kinase (PI3K) pathway, which is crucial in cell growth and division. This pathway is often activated in various forms of cancer, making PI3K inhibitors like Aliqopa valuable in oncology[2][4].

Market Assessment

The market assessment for Aliqopa is comprehensive and includes several key components:

Historical and Forecasted Sales Data

The sales data for Aliqopa from 2017 to 2030 is a critical metric. The report provides detailed historical sales figures and forecasts future sales, helping stakeholders understand the market trend and potential growth areas[1][4].

SWOT Analysis

A SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) is essential for understanding the competitive landscape. For Aliqopa, this analysis includes strengths such as its unique mechanism of action and regulatory approvals, weaknesses like potential side effects, opportunities in expanding into new markets, and threats from emerging therapies[1][4].

Regulatory Milestones

Aliqopa has received several regulatory approvals, including those in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. These milestones are crucial for its market presence and future development activities[1][4].

Market Competitors and Emerging Therapies

The market for follicular lymphoma treatments is competitive, with several other approved products:

Approved Products

Other PI3K inhibitors like Zydelig (idelalisib), Copiktra (duvelisib), Piqray (alpelisib), and Ukoniq (umbralisib) compete with Aliqopa. These drugs also target the PI3K pathway but may have different indications or side effect profiles[2].

Late-Stage Emerging Therapies

Late-stage emerging therapies, particularly those in Phase III clinical trials, pose a significant impact on the market. These therapies may offer novel approaches or improved efficacy and safety profiles, potentially altering the market dynamics for Aliqopa[1][4].

Geographical Market Trends

The market trend for Aliqopa varies across different regions:

United States

In the U.S., Aliqopa has a strong market presence due to its FDA approval and established distribution channels. The report provides detailed insights into the historical and forecasted sales data in this market[1][4].

EU5 and Japan

In the EU5 countries and Japan, the market scenario is influenced by local regulatory approvals, reimbursement policies, and the presence of other competing therapies. The report highlights the unique market conditions in these regions[1][4].

Financial Trajectory

The financial trajectory of Aliqopa is influenced by several factors:

Sales Projections

The report forecasts significant growth in Aliqopa's sales from 2017 to 2030, driven by increasing healthcare spending and the expanding patient population with follicular lymphoma[1][4].

Development Activities and Collaborations

Collaborations, mergers and acquisitions, and licensing activities related to Aliqopa development are crucial for its financial health. These activities can enhance its market position and open new revenue streams[1][4].

Patent Details and Expiry Timeline

Understanding the patent details and expiry timeline is vital for predicting the long-term financial stability of Aliqopa. The report provides insights into the patent status and potential generic competition post-patent expiry[1][4].

Challenges and Opportunities

Despite its strong market position, Aliqopa faces several challenges:

Adverse Reactions and Safety Profile

The safety profile of Aliqopa, including adverse reactions, is a critical factor that can influence patient compliance and market acceptance. Managing these risks through effective safety monitoring and patient education is essential[1][4].

Expanding Indications

There is an opportunity to expand Aliqopa's indications beyond follicular lymphoma, potentially into other types of lymphomas or cancers. This could significantly increase its market share and revenue[1][4].

Key Takeaways

• Comprehensive Market Assessment: Aliqopa's market is assessed across seven major markets, including historical and forecasted sales data.
• Competitive Landscape: The drug faces competition from other PI3K inhibitors and emerging therapies.
• Regulatory Milestones: Aliqopa has received significant regulatory approvals in key markets.
• Financial Growth: The drug is projected to see significant sales growth driven by healthcare spending and patient population expansion.
• Challenges and Opportunities: Managing adverse reactions and exploring new indications are critical for its long-term success.

FAQs

1. What is Aliqopa used for? Aliqopa is used for the treatment of follicular lymphoma, a type of non-Hodgkin lymphoma.

2. How does Aliqopa work? Aliqopa works by inhibiting the PI3K pathway, which is crucial in cell growth and division.

3. What are the key competitors of Aliqopa? Other PI3K inhibitors like Zydelig, Copiktra, Piqray, and Ukoniq are key competitors.

4. What is the forecasted market scenario for Aliqopa? The market scenario for Aliqopa is expected to grow significantly from 2017 to 2030, driven by increasing healthcare spending and patient population.

5. What are the potential challenges for Aliqopa? Aliqopa faces challenges such as adverse reactions and competition from emerging therapies.

Cited Sources

1. ResearchAndMarkets.com - Aliqopa - Drug Insight and Market Forecast, 2030
2. Kazia Therapeutics Limited - Paxalisib - For Researchers
3. BusinessWire - Copanlisib, Sold Under the Brand Name Aliqopa: A Medication for the Treatment of Follicular Lymphoma - Global Drug Insight and Market Forecast Report 2021-2030 - ResearchAndMarkets.com
4. Leukemia & Lymphoma Society - Co-Pay Resource Guide (not directly cited but referenced for context)