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 six patents protecting this drug.

This drug has two hundred and twenty-seven 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:	227
US Patents:	6
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

Constraining patent/regulatory exclusivity:

RE46621

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
Secura Bio, Inc.	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all COPIKTRA clinical trials

US Patents and Regulatory Information for COPIKTRA

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

This potential generic entry date is based on patent RE46621.

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	9,840,505
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	RE46621		Y	Y

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/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 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
Ukraine	109764	ПОХІДНІ ІЗОХІНОЛІНОНУ, КОМПОЗИЦІЯ НА ЇХ ОСНОВІ ТА ЗАСТОСУВАННЯ ЯК ІНГІБІТОРІВ РІ3K
Singapore	191897	PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
China	105102000

Supplementary Protection Certificates for COPIKTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2914296	CA 2021 00046	Denmark		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2914296	LUC00238	Luxembourg		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542 20210521
2914296	SPC/GB21/068	United Kingdom		PRODUCT NAME: DUVELISIB; REGISTERED: UK EU/1/21/1542/001(NI) 20210521; UK EU/1/21/1542/002(NI) 20210521; UK FURTHER MAS ON IPSUM 20210521

Market Dynamics and Financial Trajectory for COPIKTRA (Duvelisib)

Last updated: July 27, 2025

---

Introduction

COPIKTRA (duvelisib), developed by Verastem Oncology, represents a targeted oral cancer therapy, specifically a PI3K-δ/γ inhibitor approved by the FDA for relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Since its approval in 2018, COPIKTRA's market performance, competitive positioning, and growth prospects have been shaped by complex market dynamics and evolving industry trends within hematologic malignancies. This analysis explores the factors influencing its market landscape and forecasts its financial trajectory over the coming years.

---

Market Landscape and Therapeutic Context

Targeted Indications and Unmet Needs

COPIKTRA's primary indications—rR/R CLL/SLL and follicular lymphoma—serve significant patient populations with limited durable treatment options. Historically, the B-cell receptor signaling pathway, modulated via PI3K inhibitors, has been pivotal in managing these hematological cancers. Noteworthy competitors include Gilead's Zydelig (idelalisib), AbbVie's Venclyxto (venetoclax), and newer agents like BeiGene's Brukinsa (zanubrutinib), creating a competitive environment where differentiation and safety profile are critical.

Market Size and Penetration

Globally, the hematologic malignancies market is projected to grow substantially, driven by increasing prevalence, early diagnosis, and treatment innovations. The CLL/SLL segment alone is estimated to encompass over 130,000 patients in the U.S. and Europe [1], with a significant proportion requiring salvage therapy. COPIKTRA's positioning as an oral, targeted therapy offers potential advantages in patient compliance, yet its market share remains modest compared to established therapies.

---

Market Drivers Influencing Financial Trajectory

Regulatory and Clinical Milestones

• Initial Approval and Indications Expansion: The FDA's 2018 approval for R/R CLL/SLL provided a foundation, with subsequent approvals for additional lymphomas expanding its reach.
• Ongoing Clinical Trials: Several phase 3 trials evaluating COPIKTRA in combination regimens and expanded indications could bolster market confidence, enhance label breadth, and stimulate sales.

Safety Profile and Market Acceptance

• Adverse Events (AEs): PI3K inhibitors are associated with immune-mediated adverse effects, including hepatotoxicity, diarrhea, and colitis. Managing AEs effectively influences prescriber confidence and patient adherence.
• Competitive Safety Advantage: If COPIKTRA demonstrates a superior safety profile relative to competitors like Zydelig, it may capture increased market share, positively impacting revenue streams.

Pricing and Reimbursement Landscape

• Pricing Strategy: As a niche targeted agent, COPIKTRA's pricing remains competitive amidst a landscape of high-cost treatments. Effective reimbursement strategies via payers enhance market access.
• Off-Label Use Restrictions and Payer Policies: Payer skepticism regarding PI3K inhibitors' safety may restrain prescribing, affecting sales growth.

---

Competitive Dynamics and Market Challenges

Emerging Therapies and Composition

Advancements in other targeted therapies—Bruton’s tyrosine kinase inhibitors (e.g., ibrutinib, acalabrutinib)—and BCL-2 inhibitors (venetoclax) reshape treatment algorithms, potentially limiting COPIKTRA's use. The increasing preference for combination regimens, such as COPIKTRA with venetoclax, suggests avenues for revenue growth but also introduces competition from alternative combination therapies.

Market Penetration

Despite its clinical promise, COPIKTRA’s market penetration remains limited owing to gut safety concerns, physician familiarity with existing therapies, and the competitive therapeutic landscape. The drug’s success hinges on its ability to demonstrate superior efficacy/safety profiles and to establish robust clinical data supporting combination regimens.

---

Financial Trajectory and Revenue Outlook

Current Revenue Trends

• Sales Performance: As of fiscal year 2022, COPIKTRA's global sales approximated $40–45 million, reflecting modest adoption primarily within specialist oncology centers [2]. Growth in sales has been incremental, with fluctuations driven by prescription trends and expanding indications.

Forecasting Future Revenues

• Near-Term Outlook (2023–2025): Revenue growth is expected to be modest due to market saturation, cautious prescribing practices, and competition. However, incremental gains are plausible if Verastem secures additional approvals, expands indications, and optimizes clinical placement.
• Medium to Long-Term Potential: Breakthroughs in combination therapy marketing, improved safety profiles, and expanding geographic reach in Europe and Asia could catalyze revenues, potentially reaching mid-to-high hundreds of millions annually if the drug captures a meaningful share of the targeted patient populations.

Investment and R&D Impact

Investments in clinical trials for broader indications (e.g., solid tumors) and combination therapies could, over time, enhance COPIKTRA’s financial prospects. Abstracts indicating promising trial results bolster investor confidence and support valuation growth.

---

Regulatory and Market Risks

• Regulatory Changes: Stringent safety monitoring requirements or regulatory restrictions could hamper sales.
• Market Acceptance: Skepticism or slow physician adoption due to safety concerns remains a barrier.
• Competitive Innovations: The emergence of superior agents or novel modalities (e.g., CAR-T cell therapies) could diminish COPIKTRA’s relevance in the hematologic cancer market.

---

Key Takeaways

• Market Positioning: COPIKTRA occupies a niche in the hematology-oncology space; success depends on demonstrating favorable safety and efficacy profiles relative to competitors.
• Growth Catalysts: Additional approvals, combination regimen success, and geographic expansion are pivotal for accelerating revenue growth.
• Challenges: Competition from well-established therapies, safety perceptions, and regulatory hurdles present ongoing challenges.
• Financial Outlook: Anticipated modest revenue growth over the short term, with potential for significant gains contingent on clinical and regulatory milestones.
• Strategic Focus: Prioritizing clinical development, safety management, and payer engagement will underpin COPIKTRA’s financial trajectory.

---

FAQs

1. What are the main therapeutic advantages of COPIKTRA over existing PI3K inhibitors?
COPIKTRA’s oral administration, selective inhibition of PI3K-delta and gamma isoforms, and emerging safety profile are designed to offer improved tolerability versus earlier PI3K inhibitors like Zydelig. Its potential in combination regimens also broadens its strategic application.

2. How does COPIKTRA compare economically to its competitors?
While priced similarly to targeted oral therapies, COPIKTRA’s market penetration remains limited, constraining its revenue. Its economic competitiveness will improve if clinical data supports broader or combination use, justifying higher reimbursement levels.

3. What are the key growth areas for COPIKTRA in the next five years?
Expansion into additional lymphoma subtypes, successful combination therapy approvals, and geographic penetration in Europe and Asia are the principal growth avenues, contingent on positive clinical outcomes.

4. What are the primary risks associated with COPIKTRA’s market success?
Safety concerns, physician hesitance, competitive innovations, and payer restrictions pose substantial risks to its commercial expansion.

5. How will clinical trials influence COPIKTRA’s long-term financial prospects?
Positive trial results for new indications or combinations could significantly enhance its value by increasing patient eligibility and expanding its clinician base, ultimately driving sales growth.

---

References

[1] American Cancer Society. "Cancer Facts & Figures 2022."
[2] Verastem Oncology. Fiscal Year 2022 Financial Report.