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Last Updated: December 22, 2024

IDELALISIB - Generic Drug Details


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What are the generic drug 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
Generic Entry Date for IDELALISIB*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Oslo University HospitalPhase 2
ADC Therapeutics S.A.Phase 2
Loxo Oncology, Inc.Phase 3

See all IDELALISIB clinical trials

Pharmacology for IDELALISIB
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 ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe ⤷  Subscribe
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 ⤷  Subscribe ⤷  Subscribe
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 ⤷  Subscribe ⤷  Subscribe
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for IDELALISIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761540 132017000031007 Italy ⤷  Subscribe 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 ⤷  Subscribe PRODUCT NAME: IDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 (MITTEILUNG) 20140919
1761540 CA 2017 00007 Denmark ⤷  Subscribe PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924
1761540 PA2017004,C1761540 Lithuania ⤷  Subscribe PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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