Duvelisib - Generic Drug Details

What are the generic sources for duvelisib and what is the scope of freedom to operate?

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:	42
Patent Applications:	1,869
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
Peking Union Medical College Hospital	Phase 1/Phase 2
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1/Phase 2
Secura Bio	Early Phase 1

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	211155-001	Sep 24, 2018		RX	Yes	No
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	211155-002	Sep 24, 2018		RX	Yes	No			Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No				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/005381 Copiktra 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
Singapore	10201605472W	Certain Chemical Entities, Compositions And Methods
Taiwan	I659956
Japan	2011508782
Canada	2890105	TRAITEMENT DE CANCERS A L'AIDE DE MODULATEURS D'ISOFORME DE PI3 KINASE (TREATMENT OF CANCERS USING PI3 KINASE ISOFORM MODULATORS)
Australia	2010274075	Certain chemical entities, compositions and methods

Supplementary Protection Certificates for duvelisib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2914296	C20210034 00345	Estonia		PRODUCT NAME: DUVELISIIB;REG NO/DATE: EU/1/21/1542 21.05.2021
2914296	CA 2021 00046	Denmark		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2914296	PA2021527,C2914296	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	SPC/GB21/069	United Kingdom		SPC/GB21/069 WAS ADDED TO THE JOURNAL 7041 INCORRECTLY IDENTIFYING THE INCORRECT MAXIMUM EXPIRY DATE ON WHICH THE SPC IS BASED. PLEASE SEE THE UPDATED JOURNAL ENTRY.; APPLICANT: INTELLIKINE, LLC; 10931 NORTH TORREY PINES ROAD, LA JOLLA CA 92037, UNITED STATES OF AMERICA; PRODUCT: DUVELISIB; PRODUCT TYPE: MEDICINAL; AUTHORISED:; EU/1/21/1542/001 21 MAY 2021 (NI); EU/1/21/1542/002 21 MAY 2021 (NI) ; FURTHER MA'S ON IPSUM; ; AUTHORISED EXTENSION:; PATENT NO: EP2456444; TITLE: ADENINE DERIVATIVE AS PI3K INHIBITOR; SPC NO: SPC/GB21/069; DATE GRANTED: 05 APRIL 2024; MAXIMUM PERIOD EXPIRES ON: 14 JULY 2035; CORRECTED DATA
2914296	CR 2021 00046	Denmark		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521

Market Dynamics and Financial Trajectory of Duvelisib (COPIKTRA)

Introduction

Duvelisib, marketed as COPIKTRA, is a phosphatidylinositol 3-kinase (PI3K) inhibitor used in the treatment of various hematologic malignancies. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its approvals, performance, and significant events that have shaped its commercial journey.

FDA Approvals and Indications

Duvelisib received regular approval from the FDA in September 2018 for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Additionally, it received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies[1][3][5].

Clinical Trials and Efficacy

The approvals were based on several clinical trials, including the phase III DUO trial, which compared duvelisib to ofatumumab in patients with relapsed or refractory CLL or SLL. The trial showed that duvelisib significantly improved median progression-free survival (PFS) to 16.4 months compared to 9.1 months with ofatumumab, with an overall response rate (ORR) of 78% versus 39% for ofatumumab[1][3][5].

For FL, the single-arm multicenter phase 2 DYNAMO trial demonstrated an ORR of 42%, with 43% of responding patients maintaining their response for at least 6 months and 17% for at least 12 months[1][3][4].

Safety Profile

Duvelisib's prescribing information includes boxed warnings for fatal and/or serious infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Common adverse reactions include diarrhea or colitis, neutropenia, rash, fatigue, and pneumonia. Despite its efficacy, the drug's safety profile has been a significant concern, leading to permanent discontinuation in 35% of patients and dose reduction in 24%[1].

Market Performance and Financials

After its approval, duvelisib's commercial performance was modest. In 2019, the drug generated only $12 million in revenue for Verastem, Inc., the original developer and marketer. This underwhelming performance, combined with significant financial challenges faced by Verastem, including a loss of about $149 million in the same year, prompted the company to reevaluate its strategy[2].

Change in Ownership

In August 2020, Verastem sold the global commercial and development rights to duvelisib to Secura Bio, Inc. for $70 million upfront and up to $241 million in milestone payments. This deal allowed Verastem to focus on other pipeline projects, particularly its RAF/MEK/FAK development program, and reduced its annual expenses by about $50 million[2].

Withdrawal from the Market for FL Indication

In December 2021, Secura Bio voluntarily withdrew duvelisib from the U.S. market for the treatment of relapsed or refractory FL due to changes in the treatment landscape and the FDA's determination that the post-marketing requirements were no longer necessary. This decision did not impact other indications for duvelisib[4].

Current Market Position

Despite the withdrawal for the FL indication, duvelisib remains on the market for the treatment of CLL and SLL. The drug's performance and financial trajectory are closely tied to its ability to maintain market share in these indications and potentially expand into new ones, such as peripheral T-cell lymphoma, for which milestone payments are contingent[2][4].

Financial Projections and Milestones

Secura Bio is eligible for significant milestone payments, including $45 million for FDA and EMA approvals for peripheral T-cell lymphoma and $50 million for cumulative worldwide net sales starting at $100 million. Verastem will also receive low double-digit royalties on U.S., European, and UK sales, and 50% of licensing milestones up to $146 million outside these regions[2].

Conclusion

The market dynamics and financial trajectory of duvelisib are marked by initial regulatory successes, modest commercial performance, a change in ownership, and strategic adjustments in response to market and regulatory changes. As the treatment landscape for hematologic malignancies continues to evolve, the future of duvelisib will depend on its ability to demonstrate sustained clinical benefit and expand into new indications.

Key Takeaways

• Duvelisib received FDA approvals for CLL/SLL and FL but was later withdrawn from the FL market.
• The drug showed significant efficacy in clinical trials but has a challenging safety profile.
• Verastem sold duvelisib to Secura Bio to focus on other pipeline projects.
• Secura Bio is pursuing new indications and is eligible for significant milestone payments.
• The drug's financial performance has been modest, but future milestones and royalties could improve its financial outlook.

FAQs

Q: What are the approved indications for duvelisib?

A: Duvelisib is approved for adult patients with relapsed or refractory CLL or SLL after at least two prior therapies and was previously approved for FL, though this indication has been withdrawn.

Q: What were the key findings of the DUO trial?

A: The DUO trial showed that duvelisib significantly improved median PFS to 16.4 months compared to 9.1 months with ofatumumab, with an ORR of 78% versus 39% for ofatumumab.

Q: Why was duvelisib withdrawn from the market for FL?

A: Duvelisib was withdrawn from the U.S. market for FL due to changes in the treatment landscape and the FDA's determination that the post-marketing requirements were no longer necessary.

Q: Who currently owns the rights to duvelisib?

A: Secura Bio, Inc. currently owns the global commercial and development rights to duvelisib after acquiring them from Verastem, Inc. in 2020.

Q: What are the potential future milestones for duvelisib?

A: Secura Bio is eligible for milestone payments for FDA and EMA approvals for peripheral T-cell lymphoma and for achieving certain sales thresholds, as well as royalties on sales.

References

1. FDA: Duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia.
2. Biospace: Verastem Sells Copiktra to Secura for $311 Million to Focus on Pipeline.
3. FDA: 211155Orig1s000 211155Orig2s000 - accessdata.fda.gov.
4. Targeted Oncology: Duvelisib for R/R Follicular Lymphoma Voluntarily Pulled from the US Market.
5. OncLive: Duvelisib Improves PFS in Phase III CLL Trial.