COPANLISIB DIHYDROCHLORIDE - Generic Drug Details

What are the generic sources for copanlisib dihydrochloride and what is the scope of freedom to operate?

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

Copanlisib dihydrochloride has one hundred and fifty-four patent family members in fifty countries.

Summary for COPANLISIB DIHYDROCHLORIDE

International Patents:	154
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	68
Patent Applications:	294
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
VA Office of Research and Development	Phase 1/Phase 2
M.D. Anderson Cancer Center	Phase 2
Chinese PLA General Hospital	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			Y	Y
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
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
European Patent Office	2508525	Sels de 2,3-dihydroimidazo[1,2-C]quinazoline substitués (Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts)
Ecuador	SP13013006	SALES DE 2,3-DIHIDROIMIDAZO[1,2-C]QUINAZOLINA SUBSTITUIDA
Portugal	2694508
Japan	2006508063

COPANLISIB DIHYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Copanlisib Dihydrochloride (Aliqopa)

Introduction

Copanlisib dihydrochloride, marketed under the name Aliqopa, is a phosphatidylinositol 3-kinase (PI3K) inhibitor developed by Bayer for the treatment of adult patients with relapsed follicular lymphoma. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Initial Market Entry

Copanlisib was granted accelerated approval by the FDA on September 14, 2017, for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies[5].

Clinical Efficacy and Safety Profile

The drug demonstrated significant efficacy in clinical trials, particularly in the Chronos-1 trial, which showed a favorable risk-benefit profile. It had a manageable safety profile, distinct from oral PI3K inhibitors, likely due to its intermittent intravenous administration schedule[1].

Market Position and Competition

Initially, copanlisib was positioned as a third- or higher-line treatment for relapsed follicular lymphoma. The addition of copanlisib to formularies was expected to have a small impact on the total budget of healthcare plans. A budget impact analysis indicated that the increase in total budget would be minimal, around $0.02 per member per month, making it an affordable option for payers[2].

Combination Therapies and Ongoing Trials

Copanlisib was being investigated in several combination therapies, including with rituximab and R-CHOP chemotherapy, in phase III trials. The Chronos-3 trial showed significant improvements in progression-free survival when copanlisib was combined with rituximab, although overall survival benefits were not significant[3].

Financial Impact and Budget Analysis

The financial impact of adding copanlisib to a formulary was assessed in a budget impact model. The model found that over a 1-year period, the total budget increase would be $242,641, with 21.8% of this increase attributable to copanlisib. This small increase suggested that copanlisib was a financially viable option for healthcare plans[2].

Withdrawal from the US Market

Despite initial positive signs, Bayer decided to voluntarily withdraw Aliqopa from the US market in 2023 after the drug failed to meet its primary endpoint in the Phase III Chronos-4 trial. This trial investigated copanlisib in combination with chemotherapy in relapsed indolent non-Hodgkin’s lymphoma and did not show a progression-free survival benefit against standard immunochemotherapy[3].

Financial Implications of Withdrawal

The withdrawal of Aliqopa from the US market has significant financial implications for Bayer. The company, already facing financial challenges, had to reduce its workforce and is considering structural changes, including the separation of its crop science or consumer health business. The failure of Aliqopa to meet clinical endpoints added to these financial pressures[3].

Regulatory and Safety Concerns

PI3K inhibitors, including copanlisib, have been under scrutiny by regulatory bodies due to concerns over patient survival data and toxicities. An FDA advisory committee recommended the use of randomized clinical trials to mitigate safety concerns, further impacting the financial and market trajectory of these drugs[3].

Patient Access and Transition

Following the withdrawal, Bayer is exploring access options for patients who have responded well to copanlisib, advising them to consult with their healthcare providers. This transition period is crucial for ensuring that patients do not experience a disruption in their treatment plans[3].

Key Takeaways

• Accelerated Approval and Initial Success: Copanlisib was granted accelerated approval in 2017 based on positive Phase II data.
• Financial Viability: Initially, the drug was seen as a financially viable option for healthcare plans due to its minimal budget impact.
• Clinical Trials and Combination Therapies: The drug was being investigated in various combination therapies, showing promise in some trials but failing in others.
• Market Withdrawal: The drug was withdrawn from the US market in 2023 due to failure in a Phase III trial.
• Financial Implications: The withdrawal has significant financial implications for Bayer, exacerbating existing financial challenges.

FAQs

1. What is copanlisib dihydrochloride used for? Copanlisib dihydrochloride, marketed as Aliqopa, is used for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.

2. Why was copanlisib withdrawn from the US market? Copanlisib was withdrawn from the US market after it failed to meet its primary endpoint in the Phase III Chronos-4 trial, which investigated its use in combination with chemotherapy in relapsed indolent non-Hodgkin’s lymphoma.

3. What were the financial implications of adding copanlisib to a formulary? The addition of copanlisib to a formulary resulted in a small increase in total budget, approximately $0.02 per member per month, making it an affordable option for payers.

4. What are the safety concerns associated with PI3K inhibitors like copanlisib? PI3K inhibitors have been associated with concerning patient survival data and toxicities, prompting regulatory bodies to recommend the use of randomized clinical trials to mitigate these safety concerns.

5. What is the current status of patients who were treated with copanlisib? Patients who have responded well to copanlisib are advised to consult with their healthcare providers as Bayer explores access options for these patients.

Sources

1. "PI3K Inhibitor Copanlisib Active in Relapsed/Refractory Lymphoma" - Onclive
2. "A Budget Impact Analysis of the Introduction of Copanlisib ..." - PubMed
3. "Bayer's Lymphoma Treatment Aliqopa to be Pulled from US Market" - BioSpace
4. "209936Orig1s000 - accessdata.fda.gov" - FDA
5. "Copanlisib - New Drug Approvals" - New Drug Approvals