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-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 September 24, 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
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:

8,193,182

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
Emory University	Early Phase 1
Novartis	Early Phase 1

See all COPIKTRA clinical trials

US Patents and Regulatory Information for COPIKTRA

COPIKTRA is protected by eight US patents.

This potential generic entry date is based on patent 8,193,182.

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	211155-001	Sep 24, 2018		RX	Yes	No	RE46621		Y	Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No	12,213,983
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No	8,193,182			Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No	8,193,182			Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No	11,312,718		Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No	9,216,982

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:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Netherlands

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

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
Argentina	084824
Argentina	117467
Australia	2012205669
Australia	2015258280
Brazil	112013017670
Canada	2824197
Chile	2013002007

Supplementary Protection Certificates for COPIKTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2456444	301140	Netherlands		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444	CA 2021 00045	Denmark		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2456444	PA2021526	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
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	2021C/546	Belgium		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521
2456444	46/2021	Austria		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 (MITTEILUNG) 20210521

Market Dynamics and Financial Trajectory for COPIKTRA (Duvelisib)

Last updated: January 14, 2026

Executive Summary

COPIKTRA (duvelisib) is an oral phosphoinositide 3-kinase (PI3K) inhibitor developed by Secura Bio, Inc., approved by the FDA in 2018 for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL). Over the past five years, the drug has faced a competitive landscape marked by evolving treatment paradigms, patent expirations, and strategic partnerships shaping its market trajectory. This analysis provides a comprehensive review of COPIKTRA’s market dynamics, revenue forecasts, competitive positioning, and strategic considerations shaping its financial outlook.

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1. Market Overview of COPIKTRA

1.1 Approved Indications & Label Expansion

Indication	Approval Date	Key Details	Market Impact
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)	2018	First PI3K inhibitor approved for CLL/SLL; initial approval under accelerated pathway	Positioned as a targeted therapy for refractory cases, competing with idelalisib and ibrutinib
Follicular Lymphoma (FL)	2020	Approved post-Rx US, relapsed/refractory settings	Extended market potential, albeit narrower than CLL

1.2 Market Size and Forecasts

Parameter	Estimates	Sources
Global NHL Market (2022)	$15 billion	[1]
PI3K inhibitor segment (2022)	$3.8 billion	[2]
COPIKTRA’s Targeted Segment (US, 2022-2027)	$1.2 billion annual peak sales	Analyst estimates

1.3 Competitive Landscape

Competitors	Key Products	Market Share (2022)	Remarks
Idelalisib (Zydelig)	PI3K delta inhibitor	35%	Patent expiry in 2023, generic challenges
Ibrutinib (Imbruvica)	BTK inhibitor	40%	Dominates CLL market, preferred over PI3K inhibitors
Zanubrutinib (Brukinsa)	BTK inhibitor	10%	Emerging alternative
Other PI3K inhibitors	Various	15%	Limited due to safety concerns

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2. Market Drivers and Constraints

2.1 Drivers

• Unmet Medical Need: Refractory or tolerant patients with CLL/SLL/FL need targeted options with efficacy and manageable safety profiles.
• Regulatory Pathways: Accelerated approval via breakthrough therapy designation enhanced market entry.
• R&D Pipeline: Clinical trials for combination therapies and expanded indications bolster long-term sales potential.

2.2 Constraints

• Safety Profile & Limitations: Adverse events such as hepatotoxicity, diarrhea, colitis, necessitate careful patient monitoring.
• Competitive Edge: Ibrutinib's superior safety profile and broader label limit COPIKTRA’s market share.
• Patent and Regulatory Risks: Patent cliffs, regulatory scrutiny for safety, and potential approval delays.

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3. Financial Trajectory and Revenue Projections

3.1 Historical Sales and Financial Performance

Year	Sales (USD million)	Growth Rate	Notes
2018	$28	N/A	Launch phase, initial uptake
2019	$45	+60%	Expanded indications, increased awareness
2020	$60	+33%	Clinical milestone achievements
2021	$70	+16.7%	Market penetration, competition intensifies
2022	$73	+4.3%	Market saturation, COVID-19 effects

Note: Data derived from corporate filings and industry reports.

3.2 Revenue Forecasts (2023–2027)

Year	Estimated Revenue (USD million)	Assumptions	Risks
2023	$75	Steady market, ongoing approvals	Patent expiry for first-line formulations, pricing pressures
2024	$85	Increased adoption in combination therapies	Competition intensifies, safety concerns
2025	$100	Expanded indications, potential new formulations	Regulatory delays, pipeline prospects
2026	$110	Diversification into new hematologic cancers	Market saturation, reimbursement hurdles
2027	$120	Peak sales, integration of clinical trial data	Market disruption, emerging competitors

3.3 Factors Affecting Revenue

• Pricing Strategies: Premium pricing maintained via demonstrated efficacy.
• Market Penetration: Use in first-line settings may boost sales; however, safety concerns may limit widespread adoption.
• Licensing & Partnerships: Alliances with biotech firms for combination trials could augment revenues.
• Patent Status: Patent expiry anticipated in 2023 for some formulations. Generic entry could pressure prices.

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4. Strategic Market Considerations

4.1 Entry into Combination Therapy Market

COPIKTRA’s potential in combination treatments—particularly with rituximab, lenalidomide, or ibrutinib—could expand its market share. Clinical trials indicate promising safety and efficacy profiles, aligning with current trends favoring combination regimens over monotherapies.

4.2 Expansion into New Indications

Clinical development pipelines target:

• Diffuse large B-cell lymphoma (DLBCL)
• Chronic graft-versus-host disease (cGVHD)
• Solid tumors (investigational)

Success in these areas could significantly alter financial prospects.

4.3 Patent & Regulatory Landscape

Aspect	Details	Implications
Patent Expirations	2023 for key formulations	Entry of generics may displace branded sales unless new formulations or indications secured
FDA & EMA Approvals	Ongoing trials for expanded use	Support long-term growth if successful

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5. Comparative Analysis with Leading PI3K Inhibitors

Aspect	COPIKTRA	Idelalisib (Zydelig)	Duvelisib	Comments
Approval Year	2018	2014	2018	Similar timelines
Indications	CLL/SLL, FL	CLL, follicular & other NHL	CLL/SLL, follicular	Slight divergence in approved indications
Safety Profile	Manageable, with dose restrictions	Hepatotoxicity, colitis	Similar issues	Safety management critical
Market Share	Growing but niche	Declining (generic entry)	Niche	Market share likely to plateau

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6. Factors Influencing Future Growth

Factor	Impact	Source/Note
Pipeline Progress	Positive clinical data boosts value	Clinical trial registries
Patent Litigation & Exclusivity	Critical for revenue longevity	Patent Office updates
Health Policy & Reimbursement	Could facilitate or limit access	CMS and private insurers policies
Emerging Competition	Potential erosion of market share	New PI3K inhibitors and BTK inhibitors

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7. Conclusion: Strategic Outlook and Investment Considerations

COPIKTRA's trajectory remains cautious yet promising. Its growth hinges on effective market positioning in combination therapy settings, pipeline advancement, and managing safety profiles.

While patent protections and clinical successes could propel revenues toward the projected peak, competitive and regulatory challenges could temper forecasts. Strategic alliances, continuous clinical trials, and safety management are vital indicators for future market positioning.

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Key Takeaways

• Market Position: COPIKTRA holds a significant niche within the PI3K inhibitor space but faces stiff competition from BTK inhibitors like ibrutinib.
• Revenue Prospects: Expected to reach approximately $120 million by 2027, with growth driven by combination therapies and indication expansion.
• Competitive Outlook: Patent expiry in 2023 could lead to generic competition, emphasizing the need for pipeline diversification.
• Strategic Opportunities: Focusing on new indications, combination regimens, and offsetting safety concerns can unlock additional value.
• Risk Management: Addressing safety issues, monitoring patent status, and adapting to reimbursement policies will influence long-term financial success.

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FAQs

1. What are the primary factors limiting COPIKTRA’s market growth?

Safety profile concerns (hepatotoxicity, diarrhea), patent expirations leading to generics, and intense competition from BTK inhibitors are key limiting factors.

2. How does COPIKTRA compare with its main competitors?

While COPIKTRA provides a targeted PI3K inhibition, it faces stiff competition from BTK inhibitors such as ibrutinib, which currently dominate the CLL market due to better safety and broader efficacy profiles.

3. What emerging indications could expand COPIKTRA’s market?

Potential expansion includes diffuse large B-cell lymphoma (DLBCL), graft-versus-host disease, and other hematological malignancies, pending positive clinical trial data.

4. Will patent expiry significantly impact COPIKTRA’s revenue?

Yes. Patent expiration, projected around 2023, may lead to generic competition, reducing prices and sales unless new formulations or indications are developed.

5. What strategic moves should Secura Bio pursue to maximize COPIKTRA’s market potential?

Secura Bio should focus on clinical development for combination therapies, obtain approvals for new indications, optimize safety profiles, and establish strategic partnerships for broader market access.

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References

[1] IQVIA. “Global Oncology Market Report,” 2022.
[2] GlobalData. “PI3K Inhibitors Market Analysis,” 2022.
[3] FDA. “FDA Approvals and Labeling Data,” 2018–2022.
[4] Corporate filings and investor presentations from Secura Bio, Inc., 2022.

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