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COPIKTRA Drug Patent Profile

When do Copiktra patents expire, and what generic alternatives are available?

Copiktra is a drug marketed by Secura and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in COPIKTRA is duvelisib. One supplier is listed for this compound. Additional details are available on the duvelisib profile page.

DrugPatentWatch^® Generic Entry Outlook for Copiktra

Copiktra was eligible for patent challenges on September 24, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 17, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COPIKTRA

International Patents:	148
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	12
Drug Prices:	Drug price information for COPIKTRA
What excipients (inactive ingredients) are in COPIKTRA?	COPIKTRA excipients list
DailyMed Link:	COPIKTRA at DailyMed

See drug prices for COPIKTRA

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

NDA:

211155

Dosage:

CAPSULE;ORAL

^*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 COPIKTRA

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

Sponsor	Phase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1/Phase 2
National Cancer Institute (NCI)	Early Phase 1
Secura Bio	Early Phase 1

See all COPIKTRA clinical trials

US Patents and Regulatory Information for COPIKTRA

COPIKTRA is protected by seven US patents and one FDA Regulatory Exclusivity.

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
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No				Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No			Y	Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No

EU/EMA Drug Approvals for COPIKTRA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Secura Bio Limited	Copiktra	duvelisib	EMEA/H/C/005381 Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies. Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.	Authorised	no	no	no	2021-05-19

International Patents for COPIKTRA

When does loss-of-exclusivity occur for COPIKTRA?

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

Argentina

Australia

Brazil

Canada

Chile

China

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

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 COPIKTRA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101897881
Singapore	10202013258P	Certain Chemical Entities, Compositions And Methods
European Patent Office	2663309	PROCÉDÉS DE PRÉPARATION D'ISOQUINOLINONES ET DE FORMES SOLIDES D'ISOQUINOLINONES (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)
Malaysia	175979	CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS
Spain	2647163
China	101965336	Certain chemical entities, compositions and methods

Supplementary Protection Certificates for COPIKTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2456444	LUC00237	Luxembourg		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU1/21/1542 20210521
2456444	122021000069	Germany		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	301140	Netherlands		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444	46/2021	Austria		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 (MITTEILUNG) 20210521
2456444	21C1052	France		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444	PA2021526	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519

COPIKTRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COPIKTRA (Duvelisib)

Introduction to COPIKTRA

COPIKTRA (duvelisib) is a prescription medicine that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. It is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), having received Fast Track designation in the United States[4].

Market Growth and Drivers

The market for COPIKTRA is influenced by several key factors:

Clinical Pipeline and Emerging Therapies

The peripheral T-cell lymphoma market, where COPIKTRA is being developed, is expected to grow at a CAGR of 4.9% in the US by 2032. This growth is driven by the robust clinical pipeline and the expected launch of emerging therapies, including COPIKTRA itself[1].

Strategic Focus on T-Cell Lymphoma

Secura Bio, the company behind COPIKTRA, has shifted its strategic focus towards T-cell lymphoma after evaluating the treatment landscape for follicular lymphoma. This strategic shift is based on encouraging initial data in T-cell lymphoma, indicating a more promising market segment[4].

Regulatory Designations

COPIKTRA's Fast Track designation for PTCL is a significant driver, as it expedites the development and review process, potentially leading to earlier market entry and increased adoption[4].

Financial Performance and Milestones

Revenue and Milestones

In Q2 2024, Secura Bio achieved a significant milestone with $100 million in cumulative worldwide net sales of COPIKTRA, which entitled Verastem Oncology to a $10 million milestone payment. This payment was received in July 2024, highlighting the drug's commercial success[2].

Licensing and Asset Sales

Verastem Oncology reported total revenue of $10 million in Q2 2024, primarily from the sale of COPIKTRA license and related assets. This revenue stream is crucial for the company's financial health and indicates the value of COPIKTRA in the market[2].

Operating Expenses and Financial Health

Research and Development Expenses

Verastem Oncology's research and development expenses have been significant, reflecting the ongoing clinical trials and development activities for COPIKTRA and other pipeline products. For instance, in Q3 2024, research and development expenses were $24.754 million, indicating a substantial investment in clinical research[5].

Selling, General, and Administrative Expenses

The company also incurs considerable selling, general, and administrative expenses. In Q3 2024, these expenses were $12.276 million, which is part of the overall operational costs associated with marketing and distributing COPIKTRA[5].

Net Loss and Non-GAAP Adjustments

Net Loss

Despite the revenue from COPIKTRA, Verastem Oncology reported a net loss of $23.967 million in Q3 2024. This loss is attributed to the high operating expenses, including research and development, and other financial adjustments[5].

Non-GAAP Adjustments

The non-GAAP adjusted net loss for Q3 2024 was $35.278 million, which accounts for non-cash items such as stock-based compensation, non-cash interest, and changes in the fair value of preferred stock and warrant liabilities. These adjustments provide a clearer picture of the company's operational performance[5].

Safety and Efficacy Considerations

Treatment-Related Mortality

COPIKTRA has been associated with treatment-related mortality, particularly in patients with relapsed or refractory CLL or SLL. Extended follow-up data showed treatment-related deaths in 14% of patients, primarily due to infections. This highlights the need for careful patient selection and monitoring[3].

Future Outlook

Regulatory and Clinical Plans

Secura Bio is working closely with the FDA to develop an appropriate regulatory and clinical plan for COPIKTRA in T-cell lymphoma. The company's focus on this indication is expected to drive future growth and market penetration[4].

Market Expansion

The strategic shift towards T-cell lymphoma and the ongoing clinical trials suggest a potential for market expansion. As COPIKTRA gains more approvals and positive clinical data, it is likely to capture a larger share of the lymphoma treatment market[4].

Key Takeaways

• Market Growth: The peripheral T-cell lymphoma market is expected to grow at a CAGR of 4.9% in the US by 2032, driven by the robust clinical pipeline and emerging therapies like COPIKTRA.
• Strategic Focus: Secura Bio has shifted its focus to T-cell lymphoma, where COPIKTRA has shown promising initial data.
• Financial Performance: COPIKTRA has generated significant revenue, including a $10 million milestone payment in Q2 2024.
• Operating Expenses: High research and development expenses are a key component of Verastem Oncology's financial profile.
• Safety and Efficacy: COPIKTRA is associated with treatment-related mortality, particularly due to infections, emphasizing the need for careful patient management.
• Future Outlook: The drug's future growth is tied to its performance in T-cell lymphoma and the company's regulatory and clinical plans.

FAQs

What is COPIKTRA used for?

COPIKTRA is used to treat adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. It is also being developed for the treatment of peripheral T-cell lymphoma (PTCL)[4].

What is the current market growth outlook for COPIKTRA?

The peripheral T-cell lymphoma market, where COPIKTRA is being developed, is expected to grow at a CAGR of 4.9% in the US by 2032[1].

What are the key financial milestones for COPIKTRA in 2024?

In Q2 2024, Secura Bio achieved $100 million in cumulative worldwide net sales of COPIKTRA, resulting in a $10 million milestone payment to Verastem Oncology[2].

What are the main safety concerns associated with COPIKTRA?

COPIKTRA is associated with treatment-related mortality, particularly due to infections, which occurred in 14% of patients with relapsed or refractory CLL or SLL[3].

What is the future regulatory and clinical plan for COPIKTRA?

Secura Bio is working with the FDA to develop an appropriate regulatory and clinical plan for COPIKTRA in T-cell lymphoma, focusing on new applications where initial data appear encouraging[4].

How does COPIKTRA's mechanism of action contribute to its therapeutic efficacy?

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), specifically targeting PI3K-delta and PI3K-gamma, which are enzymes that support the growth and survival of malignant cells. This mechanism helps in reducing the proliferation of malignant cells and disrupting the supportive tumor microenvironment[4].