Idelalisib - Generic Drug Details

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

Idelalisib is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Idelalisib has one hundred and eleven patent family members in forty countries.

There are two drug master file entries for idelalisib. One supplier is listed for this compound.

Summary for idelalisib

International Patents:	111
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	61
Patent Applications:	2,356
What excipients (inactive ingredients) are in idelalisib?	idelalisib excipients list
DailyMed Link:	idelalisib at DailyMed

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

Constraining patent/regulatory exclusivity:

9,469,643

Dosage:

TABLET;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 idelalisib

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

Sponsor	Phase
Oslo University Hospital	Phase 2
ADC Therapeutics S.A.	Phase 2
Loxo Oncology, Inc.	Phase 3

See all idelalisib clinical trials

Pharmacology for idelalisib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for idelalisib

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

Paragraph IV (Patent) Challenges for IDELALISIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYDELIG	Tablets	idelalisib	100 mg and 150 mg	205858	1	2022-03-23

US Patents and Regulatory Information for idelalisib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	8,865,730		Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	9,492,449
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	9,469,643			Y

Expired US Patents for idelalisib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	6,800,620
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,637,533
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	6,949,535

EU/EMA Drug Approvals for idelalisib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Zydelig	idelalisib	EMEA/H/C/003843 Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.	Authorised	no	no	no	2014-09-18

International Patents for idelalisib

Country	Patent Number	Title	Estimated Expiration
Portugal	1761540
Ecuador	SP14020478
World Intellectual Property Organization (WIPO)	2010057048

Supplementary Protection Certificates for idelalisib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761540	132017000031007	Italy		PRODUCT NAME: IDELALISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYDELIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/938, 20140919
1761540	9/2017	Austria		PRODUCT NAME: IDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 (MITTEILUNG) 20140919
1761540	CA 2017 00007	Denmark		PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924

Idelalisib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Idelalisib

Introduction

Idelalisib, marketed under the brand name Zydelig, is a phosphatidylinositol 3-kinase (PI3K) inhibitor that was initially approved by the U.S. Food and Drug Administration (FDA) in July 2014 for the treatment of relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL). Here, we delve into the market dynamics and financial trajectory of idelalisib, highlighting its rise, challenges, and eventual withdrawal from certain indications.

Approval and Initial Market Performance

Idelalisib received accelerated approval based on the results of a phase II study, which showed promising response rates in patients with FL and SLL. This approval was contingent on the generation of additional evidence to support its clinical benefit[4].

During its initial market authorization period (2014-2016), idelalisib generated significant revenue. Gilead Sciences reported cumulative sales revenue of $842 million from 2014 to 2022, with annual sales peaking at $168 million in 2016[1].

Safety Concerns and Regulatory Response

However, the market trajectory of idelalisib was soon marred by serious safety concerns. By 2016, postmarketing reviews revealed increased risks of serious adverse events (SAEs), fatal adverse events (FAEs), and deaths associated with idelalisib treatment. The cumulative relative risk for SAEs was 1.86, for FAEs was 3.30, and for death was 1.35 by the end of the initial postmarketing period[1].

These safety concerns led to the termination of several postmarketing registry trials and a significant decline in sales. Despite these issues, idelalisib remained on the market for another six years, with minimal additional evidence generation to support its safety and efficacy.

Decline in Sales and Revenue

The period from 2016 to 2022 saw a steady decline in annual sales of idelalisib. The revenue dropped from $168 million in 2016 to $62 million in 2021. This decline was largely due to the emerging safety concerns and the lack of new evidence to mitigate these risks[1].

Voluntary Withdrawal

In 2022, Gilead Sciences voluntarily withdrew idelalisib from the market for the indications of FL and SLL, citing poor enrollment in confirmatory studies and ongoing safety concerns. However, idelalisib remains available as part of a combination treatment for relapsed chronic lymphocytic leukemia (CLL) in the U.S.[4].

Market Impact and Future Projections

The withdrawal of idelalisib for certain indications has significant implications for the market. While the drug is no longer approved for FL and SLL, its continued use in CLL treatment means it still holds a niche in the market.

However, the broader market for PI3K inhibitors has been impacted by the safety concerns associated with idelalisib. Other PI3K inhibitors like copanlisib, duvelisib, and umbralisib have also faced scrutiny over their safety profiles, leading to a cautious approach in their adoption[1].

Market Segmentation and Forecast

Despite the challenges faced by idelalisib, the market for PI3K inhibitors is expected to see growth, albeit with a focus on safer alternatives. Market research indicates that the idelalisib market, though impacted, is part of a larger segment that is anticipated to expand from 2023 to 2031. The market size is segmented by type, application, and geographical regions, with projections indicating continued growth driven by research and medical applications[2].

Key Takeaways

• Accelerated Approval and Safety Concerns: Idelalisib's accelerated approval highlighted the need for closer monitoring of safety and efficacy post-approval.
• Revenue Trajectory: The drug generated significant revenue initially but saw a decline due to safety concerns.
• Voluntary Withdrawal: Gilead Sciences withdrew idelalisib for FL and SLL indications in 2022 due to poor enrollment in confirmatory studies and ongoing safety issues.
• Market Impact: The withdrawal has implications for the broader PI3K inhibitor market, with a focus on safer alternatives.
• Future Projections: Despite challenges, the market for PI3K inhibitors is expected to grow, driven by research and medical applications.

FAQs

What was the initial approval basis for idelalisib?

Idelalisib was approved by the FDA in July 2014 based on the results of a phase II study showing promising response rates in patients with follicular lymphoma (FL) and small lymphocytic lymphoma (SLL)[4].

What were the key safety concerns associated with idelalisib?

The key safety concerns included increased risks of serious adverse events (SAEs), fatal adverse events (FAEs), and deaths associated with idelalisib treatment, as evidenced by postmarketing reviews[1].

Why was idelalisib withdrawn from the market for certain indications?

Idelalisib was voluntarily withdrawn by Gilead Sciences in 2022 for the indications of FL and SLL due to poor enrollment in confirmatory studies and ongoing safety concerns[4].

What is the current market status of idelalisib?

Idelalisib remains on the market in the U.S. as part of a combination treatment for relapsed chronic lymphocytic leukemia (CLL)[4].

How has the safety profile of idelalisib impacted the broader PI3K inhibitor market?

The safety concerns associated with idelalisib have led to a cautious approach in the adoption of other PI3K inhibitors, with a focus on ensuring safer alternatives[1].

Sources

1. Clinical Trials Portfolio and Regulatory History of Idelalisib in Indolent Non-Hodgkin Lymphoma: JAMA Internal Medicine.
2. Global Idelalisib(CAL-101) Market Size, Scope And Forecast Report: Market Research Intellect.
3. AstraZeneca PLC Second Year-End Late-Stage Pipeline Investor Science Webcast Transcript: AstraZeneca.
4. Gilead Withdraws Idelalisib to Treat FL: ASH Clinical News.
5. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia: ResearchGate.