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-nine patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for DUVELISIB

International Patents:	229
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	47
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
City of Hope Medical Center	PHASE2
National Cancer Institute (NCI)	PHASE2
Secura Bio, 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			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			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
World Intellectual Property Organization (WIPO)	2012097000
Japan	2016522212
Hungary	E040126
China	102711767
Croatia	P20150586

Supplementary Protection Certificates for DUVELISIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2914296	C202130065	Spain		PRODUCT NAME: DUVELISIB; NATIONAL AUTHORISATION NUMBER: EU/1/21/1542; DATE OF AUTHORISATION: 20210519; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1542; DATE OF FIRST AUTHORISATION IN EEA: 20210519
2914296	PA2021527	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	C202130064	Spain		PRODUCT NAME: DUVELISIB; NATIONAL AUTHORISATION NUMBER: EU/1/21/1542; DATE OF AUTHORISATION: 20210519; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1542; DATE OF FIRST AUTHORISATION IN EEA: 20210519
2914296	21C1053	France		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444	2021C/546	Belgium		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521

Market Dynamics and Financial Trajectory for Duvelisib

Last updated: February 13, 2026

Overview

Duvelisib (brand name: Copiktra) is an oral phosphoinositide 3-kinase (PI3K) delta/gamma inhibitor approved for certain hematologic malignancies. Initially approved by the FDA in 2018, it targets relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL). The drug's market penetration faces competition from other PI3K inhibitors and emerging therapies in oncology.

Market Size and Growth Drivers

• Global Hematologic Malignancies Market: Estimated at $16 billion in 2022, with a compound annual growth rate (CAGR) of 6% to 8% projected until 2028.
• Duvelisib Market Share: Limited due to market access constraints, competition, and safety profile concerns.
• Key Indications:
  • CLL/SLL (market size approx. $4 billion globally)
  • Follicular lymphoma (approx. $3 billion globally)
• Market Penetration Factors:
  • Efficacy in relapsed/refractory settings
  • Safety concerns, especially adverse events leading to limited adoption
  • Competition from drugs like idelalisib (Zydelig), copanlisib, relapsed/refractory BTK inhibitors (ibrutinib, acalabrutinib), and CAR-T therapies

Regulatory and Market Access Status

• FDA (2018): Approved for CLL/SLL and FL
• European Medicines Agency (EMA): Approved for CLL/SLL
• Off-label Use and Line of Therapy: Primarily used in later lines due to safety profile and competition; no significant expansion into earlier lines
• Pricing Strategy: Approximate US list price at $12,000–$14,000 per month; reimbursement challenges limit accessible patient pool

Financial Performance and Projections

• Revenue (2022): Estimated at $70–$100 million, with sales growth expected to remain modest due to limited market penetration
• Cost Structure:
  • R&D investments, especially in combination trials and new indications
  • Commercial expenses aligned with niche oncology markets
• Profitability: Not currently profitable, typical for niche oncology drugs with limited sales volume

Growth Challenges and Opportunities

• Challenges:
  • Safety concerns reduce off-label use
  • Competitive landscape dominated by more established therapies
  • Limited indication expansion options
• Opportunities:
  • Investigational studies targeting combination therapies
  • Potential approval for new indications, including autoimmune conditions
  • Orphan drug status for specific subpopulations may provide incentives

Competitive Landscape

Drug	Indications	Market Status	Key Points
Idelalisib	CLL, SLL	Marketed	First PI3K delta inhibitor, safety concerns restrict use
Copanlisib	Follicular lymphoma, others	Marketed	IV formulation, different kinase selectivity
Umbralisib	CLL, FL (withdrawn in some regions)	Limited, withdrawn in some markets	Safety profile improved in specific contexts
BTK inhibitors	Ibrutinib, Acalabrutinib	Market leader	Oral, broader adoption, more favorable safety profiles

Regulatory and Scientific Pipeline

• Ongoing clinical trials evaluating duvelisib in combination regimens for lymphoma and other hematologic diseases
• Preclinical studies exploring autoimmune disease applications, seeking to broaden the market

Key Financial Insights

• Limited revenue owing to competitive pressures and safety issues
• R&D investment continues to support potential label expansions
• Market growth under current conditions unlikely to surpass 15% CAGR over the next five years, mainly due to market saturation and safety concerns

Summary

Duvelisib’s financial trajectory remains constrained, with sales limited by safety profile issues and stiff market competition. While pipeline efforts and potential new indications may unlock future revenue streams, near-term growth prospects are muted. Strategic focus on combination therapies and niche indications could stabilize its market presence.

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Key Takeaways

• Duvelisib’s market is limited by safety concerns, competition, and moderate efficacy.
• Global hematologic malignancies market growth supports incremental sales.
• Current revenue estimates for 2022 range between $70 million and $100 million.
• Significant R&D investments are aimed at expanding indications and improving safety profiles.
• The drug faces a challenging competitive landscape dominated by oral BTK inhibitors and monoclonal antibodies.

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FAQs

1. What are the primary indications for duvelisib?
Relapsed or refractory CLL, SLL, and follicular lymphoma.

2. How does duvelisib compare to competitors like idelalisib?
It has similar efficacy but is often limited in use due to safety concerns; idelalisib faced similar issues but has a broader market presence.

3. What is the market outlook for duvelisib?
Limited growth due to safety profile restrictions and intense competition; future potential hinges on new indications and combination therapies.

4. Are there any pipeline developments for duvelisib?
Yes, ongoing trials involve combination therapies and exploration in autoimmune diseases, which could expand its market.

5. What factors could enhance duvelisib’s financial performance?
Approval for additional indications, improved safety profiles, and successful combination strategies could increase sales.

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References

1. FDA Approval Documents for Copiktra (2023).
2. Market data reports from IQVIA and Global Data (2022).
3. Competitive landscape analysis from Evaluate Pharma (2022).
4. Clinical Trial Registry data (clinicaltrials.gov).
5. Industry analysis reports (Bloomberg, 2023).