COPIKTRA Drug Patent Profile

When do Copiktra patents expire, and when can generic versions of Copiktra launch?

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

This drug has two hundred and twenty-nine patent family members in thirty-nine 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:	229
US Patents:	6
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for COPIKTRA

COPIKTRA is protected by eight 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
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	Y
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

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 Africa	201005391	CERTAIN CHEMICAL ENTITIES,COMPOSITIONS AND METHODS
Japan	5868596
Australia	2013337717
Taiwan	I546305

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
2914296	PA2021527	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	132021000000173	Italy		PRODUCT NAME: DUVELISIB(COPIKTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1542, 20210521
2914296	LUC00238	Luxembourg		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542 20210521

COPIKTRA (Duvelisib) Investment Analysis

Last updated: February 19, 2026

Duvelisib, marketed as Copiktra, is an oral kinase inhibitor targeting phosphoinositide 3-kinase (PI3K) delta and gamma. This analysis examines the investment fundamentals of Copiktra, including its market positioning, clinical data, competitive landscape, and patent status, to inform R&D and investment decisions.

What is the Current Market Status of Copiktra?

Copiktra is approved for two specific indications in adult patients. The U.S. Food and Drug Administration (FDA) first approved Copiktra on September 24, 2018, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least three prior lines of therapy. On February 25, 2020, the FDA expanded its indication to include adult patients with relapsed or refractory marginal zone lymphoma (MZL) after at least three prior lines of therapy.

The drug's initial development was led by Verastem Oncology, which was later acquired by Inflection Point in December 2022. Copiktra is now part of Inflection Point's portfolio.

What is the Clinical Efficacy of Copiktra?

The FDA approvals for Copiktra were based on data from single-arm clinical trials demonstrating substantial efficacy in heavily pre-treated patient populations.

For relapsed or refractory FL, the pivotal study was Study 101-007. In this trial, 133 patients received Copiktra 75 mg orally twice daily. The overall response rate (ORR) was 42% (95% confidence interval [CI]: 33%-51%). Complete response rate was 13%, and partial response rate was 29% [1]. The median duration of response (DOR) was 9.1 months [1].

For relapsed or refractory MZL, the approval was based on Study 101-008, which enrolled 107 patients who received Copiktra 75 mg orally twice daily. The ORR in this cohort was 40% (95% CI: 31%-50%). Complete response rate was 13%, and partial response rate was 27% [2]. The median DOR was 12.7 months [2].

Safety data from these trials indicated that the most common adverse reactions were diarrhea, fatigue, nausea, neutropenia, and rash. Grade 3 or higher adverse events included neutropenia, anemia, thrombocytopenia, and infections [1, 2].

How Does Copiktra Fit into the Competitive Landscape?

The therapeutic landscape for relapsed or refractory FL and MZL is characterized by multiple treatment options, including other targeted therapies, immunotherapies, and chemotherapy regimens. This necessitates a comparative analysis of Copiktra against these alternatives.

Competition in Relapsed/Refractory Follicular Lymphoma (FL)

• PI3K Inhibitors: Idelalisib (Zydelig), also a PI3K inhibitor, was approved for FL prior to Copiktra. However, idelalisib has a more restrictive label due to safety concerns, often limiting its use to third-line treatment. Copiktra's dual PI3K delta and gamma inhibition is proposed to offer a different safety and efficacy profile compared to idelalisib, which primarily targets PI3K delta.
• BTK Inhibitors: Bruton's tyrosine kinase (BTK) inhibitors, such as acalabrutinib (Calquence) and zanubrutinib (Brukinsa), have demonstrated significant efficacy in FL, often in earlier lines of therapy than Copiktra's current indications. These agents are now standard of care in various settings, impacting the market for other therapies in relapsed/refractory disease.
• Chemoimmunotherapy: Regimens like R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and R-Benda (rituximab, bendamustine) remain treatment options, particularly for patients with less aggressive disease or those who have not responded to targeted agents.
• CAR T-Cell Therapy: While not yet a standard for FL, CAR T-cell therapies are being investigated and approved for other B-cell malignancies and represent a potential future competitor in refractory settings.

Competition in Relapsed/Refractory Marginal Zone Lymphoma (MZL)

• Chemoimmunotherapy: Rituximab-based regimens, as well as cyclophosphamide, vincristine, and prednisone (CVP), are common first-line and salvage treatments for MZL.
• BTK Inhibitors: Similar to FL, BTK inhibitors are increasingly used in relapsed/refractory MZL, demonstrating high response rates and favorable tolerability profiles.
• Other Targeted Therapies: The complexity of MZL subtypes (nodal, splenic, extranodal) means that treatment responses can vary. Other targeted agents and novel investigational therapies are under development.

Copiktra's current positioning as a treatment for heavily pre-treated patients in both FL and MZL means it competes in a segment where patients have exhausted multiple prior therapies. Its efficacy in this challenging population, demonstrated by its ORRs, is its primary value proposition. However, the emergence of BTK inhibitors with broader labels and strong efficacy across multiple lines of therapy presents a significant competitive challenge.

What is the Patent Landscape for Copiktra?

The patent exclusivity for Copiktra is a critical factor in its long-term commercial viability. Patents protect the drug from generic competition, allowing the innovator to recoup R&D investments.

• Composition of Matter Patents: Patents covering the duvelisib molecule itself are fundamental. These patents typically have a long lifespan, often extending for 20 years from the filing date, with potential for extensions. For duvelisib, key composition of matter patents are likely to have expired or be nearing expiration in major markets.
• Method of Use Patents: Patents related to specific uses, dosages, or patient populations can provide additional layers of protection. These patents can extend market exclusivity beyond the expiration of the composition of matter patents. Inflection Point and its predecessors would hold patents covering the approved indications for FL and MZL, as well as potentially for other explored therapeutic areas.
• Formulation Patents: Patents on the specific formulation of Copiktra (e.g., tablet, capsule) can also contribute to market exclusivity.

While specific patent expiry dates are subject to complex legal and regulatory frameworks (including potential patent term extensions and data exclusivity provisions), the general trend for small molecule drugs like duvelisib is that the core composition of matter patents expire approximately 20 years after their priority filing date. For Copiktra to maintain exclusivity, it would rely on secondary patents and regulatory exclusivities. The absence of significant patent litigation or extensive generic filings often indicates a relatively secure patent position in the near term, although a thorough patent landscape analysis by legal counsel is essential for definitive assessment.

What are the Key Financial and Commercial Considerations?

The commercial success of Copiktra is influenced by sales performance, pricing, market access, and the evolving reimbursement landscape.

• Sales Performance: Copiktra's sales have been modest since its launch. For example, in 2022, Verastem Oncology reported net product revenue for Copiktra of $77.5 million [3]. Inflection Point's financial reports will provide the most current sales figures. These figures reflect its positioning in niche indications for heavily pre-treated patients.
• Pricing and Reimbursement: The pricing of oncology drugs is a significant factor. Copiktra is priced as a specialty medication, reflecting its targeted nature and the complexities of treating advanced hematological malignancies. Market access and formulary placement by payers are crucial for patient uptake. Reimbursement challenges or restrictions can limit prescription volume.
• R&D Pipeline Integration: For Inflection Point, Copiktra's performance must be viewed within the context of its broader R&D pipeline and existing commercial products. The acquisition of Verastem and Copiktra was strategic, and its future is tied to Inflection Point's overall corporate strategy and investment in further development or lifecycle management.

Key Takeaways

Copiktra (duvelisib) is approved for relapsed/refractory follicular lymphoma and marginal zone lymphoma in heavily pre-treated adult patients, demonstrating objective response rates of approximately 40-42% in clinical trials. Its competitive landscape includes established chemoimmunotherapy, emerging BTK inhibitors, and other targeted agents, with BTK inhibitors posing a significant challenge due to their broad utility across multiple lines of therapy. The patent exclusivity for the core duvelisib molecule is subject to expiration, with future protection likely reliant on secondary patents and lifecycle management strategies. Sales performance has been modest, reflecting its niche indication, and its commercial success hinges on continued market access, reimbursement, and integration into Inflection Point's broader portfolio.

Frequently Asked Questions

1. What are the primary therapeutic areas for Copiktra's current approvals? Copiktra is approved for adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL), both after at least three prior lines of therapy.

2. What is the mechanism of action for Copiktra? Copiktra is an oral kinase inhibitor that targets phosphoinositide 3-kinase (PI3K) delta and gamma.

3. What were the key efficacy endpoints demonstrated in the pivotal trials for Copiktra? In the pivotal trials for FL and MZL, the primary efficacy endpoints were overall response rate (ORR), with Copiktra demonstrating ORRs of 42% and 40% respectively.

4. Which companies are currently associated with the commercialization of Copiktra? Copiktra was initially developed by Verastem Oncology and is now part of the portfolio of Inflection Point, following Inflection Point's acquisition of Verastem.

5. What is the expected impact of patent expiries on Copiktra's market exclusivity? The expiration of core composition of matter patents for duvelisib will likely lead to increased competition from generic manufacturers unless Inflection Point possesses and can successfully defend secondary patents or benefit from regulatory exclusivities.

Citations

[1] Copiktra™ (duvelisib) Prescribing Information. (2023). U.S. Food and Drug Administration.

[2] U.S. Food and Drug Administration. (2020, February 25). FDA approves duvelisib (Copiktra) for relapsed or refractory marginal zone lymphoma. FDA News Release.

[3] Verastem Oncology. (2023, March 7). Verastem Oncology Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update. [Press release].