DUVELISIB - Generic Drug Details

What are the generic drug sources for duvelisib and what is the scope of patent protection?

Duvelisib is the generic ingredient in one branded drug marketed by Secura and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Duvelisib has two hundred and twenty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for DUVELISIB

International Patents:	227
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	46
Drug Prices:	Drug price trends for DUVELISIB
What excipients (inactive ingredients) are in DUVELISIB?	DUVELISIB excipients list
DailyMed Link:	DUVELISIB at DailyMed

See drug prices for DUVELISIB

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

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 DUVELISIB

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

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	PHASE1
Secura Bio, Inc.	PHASE1
Genentech, Inc.	PHASE1

See all DUVELISIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DUVELISIB

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for DUVELISIB

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

EU/EMA Drug Approvals for DUVELISIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Secura Bio Limited	Copiktra	duvelisib	EMEA/H/C/005381Copiktra 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 DUVELISIB

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3150609
South Africa	201005391	CERTAIN CHEMICAL ENTITIES,COMPOSITIONS AND METHODS
China	103648499
Ukraine	109878	ПОХІДНІ ІЗОХІНОЛІНОНУ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЇХ ОСНОВІ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ ЗАХВОРЮВАНЬ (ВАРІАНТИ)
New Zealand	717410
Malaysia	191407

Supplementary Protection Certificates for DUVELISIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2914296	301141	Netherlands		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2914296	2021C/547	Belgium		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521
2914296	47/2021	Austria		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 (MITTEILUNG) 20210521
2914296	CA 2021 00046	Denmark		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2914296	132021000000176	Italy		PRODUCT NAME: DUVELISIB(COPIKTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1542, 20210521
2456444	PA2021526	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519

Market Dynamics and Financial Trajectory for Duvelisib

Last updated: July 28, 2025

Introduction

Duvelisib, marketed primarily under the brand name Copiktra, is an oral dual inhibitor targeting phosphoinositide 3-kinases delta and gamma (PI3Kδ/γ). Developed by_VER sed, its approval by the U.S. Food and Drug Administration (FDA) in 2018 marked a significant milestone in targeted oncology therapy, focusing on relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL). As a member of the PI3K inhibitor class, duvelisib entered a competitive landscape characterized by rapidly evolving oncology therapies, regulatory challenges, and shifting pharmaceutical investment patterns. Analyzing the drug’s market potential and financial trajectory requires an understanding of its current positioning, unmet medical needs, competitive environment, and broader industry trends.

Market Overview

Therapeutic Landscape and Indications

Duvelisib addresses hematologic malignancies, notably CLL/SLL and FL, with a substantial patient population. According to the American Cancer Society, approximately 165,000 individuals in the U.S. are diagnosed with CLL, with a significant portion relapsed or refractory cases eligible for PI3K inhibitor therapy [1]. The global market for PI3K inhibitors, estimated to reach USD 4.5 billion by 2025, is driven by the expanding prevalence of lymphoid cancers and targeted therapy adoption [2].

Competitive Environment

Duvelisib competes with several other PI3K inhibitors, notably:

• Idelalisib (Zydelig) by Gilead Sciences
• Copanlisib (Aliqopa) by Bayer
• Umbralisib (marketed by TG Therapeutics)

Idelalisib, the first FDA-approved PI3Kδ inhibitor, faces challenges related to immune-related adverse events, which restrain its market growth. Copanlisib, an intravenous agent, offers an alternative administration route, but limited convenience compared to oral duvelisib. The emergence of novel agents, including BTK inhibitors such as ibrutinib and acalabrutinib, further complicates the positioning of duvelisib within treatment algorithms.

Regulatory and Safety Considerations

The setback in the market trajectory stems from safety concerns—enteritis, colitis, pneumonitis, and hepatotoxicity—highlighted during post-marketing surveillance and clinical trials [3]. These safety signals influence prescriber preferences and reimbursement decisions, emphasizing the importance of robust safety profiles for sustainable market presence.

Market Dynamics

Adoption Drivers

• Unmet Medical Needs: A significant subset of patients who do not tolerate or respond to BTK inhibitors represent an opportunity for duvelisib.
• Oral Administration Advantage: Convenience compared to infusion-based therapies enhances patient compliance.
• Line of Therapy: Currently approved for relapsed/refractory cases, but ongoing clinical trials aim to expand indications to earlier lines, broadening its potential market.

Barriers to Market Penetration

• Safety Profile: The adverse event profile necessitates careful patient monitoring, potentially limiting widespread adoption.
• Competition: Availability of alternative agents with differing safety and convenience profiles shape prescribing trends.
• Price and Reimbursement: Pricing strategies and insurer coverage critically influence commercialization success.

Market Penetration and Projected Revenue

Initial sales post-approval in 2018 showed modest figures, estimated around USD 40 million globally in 2019 [4]. Growth has been hampered by safety concerns and limited indications. However, with the expansion of clinical trials and real-world evidence demonstrating efficacy in specific subsets, the revenue trajectory is poised for gradual acceleration. Industry analysts project duvelisib's peak annual sales could reach USD 200-300 million by 2025 if safety and label expansions are successfully navigated [5].

Financial Trajectory

Investment and Development Costs

Developing duvelisib involved extensive clinical trials, with expenses approximating USD 300 million based on typical oncology drug development pipelines [6]. Post-approval marketing, safety monitoring, and potential label extensions entail ongoing costs that influence net profitability.

Revenue Streams

• Direct Sales: Generated from prescriptions reimbursed through healthcare payers.
• Partnership Agreements: Licensing or co-marketing deals could augment revenue, especially if the sponsoring company seeks to expand its footprint or share commercialization risks.

Economic Forecasts

Given the competitive landscape, duvelisib's financial success hinges on:

• Market Adoption: Accelerated through physician education and favorable safety profiles.
• Regulatory Approvals: Including potential indications for earlier lines of therapy or combination regimens.
• Pricing Strategy: Balancing affordability with R&D recovery and competitive positioning.

Strategic Outlook

Opportunities

• Label Expansion: Conducting Phase 3 trials in combination with other agents, such as bendamustine or rituximab, to demonstrate superior efficacy.
• New Indications: Exploring solid tumors or other hematologic malignancies with PI3K pathway involvement.
• Pharmacovigilance Improvements: Implementing protocols to mitigate adverse events enhances safety perception and adoption.

Threats

• Market Saturation: Several PI3K inhibitors already established.
• Regulatory Setbacks: Safety issues may lead to restrictions or withdrawal.
• Competitive Innovation: Next-generation therapies, including CAR-T cells, might redefine treatment paradigms.

Key Takeaways

• Duvelisib operates within a highly competitive and evolving hematologic oncology market, with growth potential contingent on safety management and label expansion.
• The drug’s financial trajectory depends on overcoming regulatory safety concerns, broadening indications, and optimizing pricing strategies.
• Strategic partnerships and clinical advancements are vital to capture unmet needs and accelerate revenue growth.
• The pharmaceutical industry’s ongoing innovation in targeted therapies and immuno-oncology can either pose competitive threats or facilitate combination approaches leveraging duvelisib’s mechanism.
• Continued investment in pharmacovigilance, physician education, and real-world evidence will be crucial in realizing its market potential.

FAQs

1. What are the primary indications for duvelisib?
Duvelisib is FDA-approved for relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL), typically after other treatments have failed.

2. How does duvelisib compare safety-wise to other PI3K inhibitors?
While effective, duvelisib has a notable risk of immune-mediated adverse events, including diarrhea, colitis, pneumonitis, and hepatotoxicity, similar to other PI3K inhibitors like idelalisib. Safety management and patient monitoring are essential.

3. What is the commercial outlook for duvelisib in the next five years?
Potential growth hinges on expanding indications, demonstrating improved safety profiles, and integrating into combination therapies—factors that could elevate peak sales to USD 200-300 million annually.

4. Are there ongoing clinical trials that could influence duvelisib’s market trajectory?
Yes, numerous trials are exploring duvelisib in combination therapies and earlier lines of treatment across various malignancies, promising expanded utility if outcomes are favorable.

5. What strategic moves could enhance duvelisib’s market position?
Label expansion through clinical trials, improving safety profiles, forming partnerships with life sciences firms, and leveraging real-world evidence can strengthen its market share.

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References

[1] American Cancer Society. (2022). “Cancer Facts & Figures 2022.”
[2] Grand View Research. (2021). “PI3K Inhibitors Market Size & Share Analysis.”
[3] FDA. (2018). “FDA Approves Duvelisib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.”
[4] EvaluatePharma. (2020). “Pharmaceutical Sales Data.”
[5] GlobalData. (2021). “Oncology Market Outlook: PI3K Inhibitors.”
[6] DiMasi et al. (2016). “Innovation in the pharmaceutical industry: New estimates of R&D costs.” Journal of Health Economics.