ZYDELIG Drug Patent Profile

Which patents cover Zydelig, and what generic alternatives are available?

Zydelig is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ZYDELIG is idelalisib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.

DrugPatentWatch^® Generic Entry Outlook for Zydelig

Zydelig was eligible for patent challenges on July 23, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2033. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ZYDELIG

International Patents:	111
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	13
Patent Applications:	1,039
Drug Prices:	Drug price information for ZYDELIG
What excipients (inactive ingredients) are in ZYDELIG?	ZYDELIG excipients list
DailyMed Link:	ZYDELIG at DailyMed

See drug prices for ZYDELIG

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

Constraining patent/regulatory exclusivity:

9,469,643

NDA:

205858

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 ZYDELIG

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

Sponsor	Phase
Loxo Oncology, Inc.	Phase 3
Prospect Creek Foundation	Phase 1
Oregon Health and Science University	Phase 1

See all ZYDELIG clinical trials

Pharmacology for ZYDELIG

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

Paragraph IV (Patent) Challenges for ZYDELIG

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 ZYDELIG

ZYDELIG is protected by nine US patents.

This potential generic entry date is based on patent 9,469,643.

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
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No	8,865,730		Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes	9,469,643			Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No	RE44638		Y	Y

Expired US Patents for ZYDELIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,138,195
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014	6,800,620
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,637,533

EU/EMA Drug Approvals for ZYDELIG

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 ZYDELIG

When does loss-of-exclusivity occur for ZYDELIG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

India

Japan

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

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 ZYDELIG around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013134288
Lithuania	C1761540
European Patent Office	3943494	QUINAZOLINONES UTILISÉES EN TANT QU'INHIBITEURS DE LA PHOSPHATIDYLINOSITOL 3-KINASE DELTA HUMAINE (QUINAZOLINONES AS INHIBITORS OF HUMAN PHOSPHATIDYLINOSITOL 3-KINASE DELTA)

Supplementary Protection Certificates for ZYDELIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761540	C20170009 00226	Estonia		PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014
1761540	300867	Netherlands		PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919
1761540	2017/006	Ireland		PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/14/938 20140918

Market Dynamics and Financial Trajectory for Zydelig

Introduction

Zydelig, developed by Gilead Sciences, is a first-in-class PI3K inhibitor used in the treatment of certain types of blood cancers, including chronic lymphocytic leukemia (CLL), indolent B-cell non-Hodgkin's lymphoma, and small lymphocytic lymphoma (SLL). Here, we delve into the market dynamics and financial trajectory of Zydelig, highlighting its launch, performance, and the challenges it has faced.

Launch and Initial Performance

Zydelig was launched in July 2014 with promising data, particularly when combined with Roche's Rituxan. This combination showed significant efficacy in delaying cancer growth, with a median progression-free survival of 10.7 months compared to 5.5 months with Rituxan alone[1].

Market Expectations and Competition

At the time of its launch, Zydelig was expected to achieve blockbuster sales, with estimates ranging from $1.2 billion to $1.5 billion by 2017. However, the drug faced intense competition from other treatments, notably Johnson & Johnson and AbbVie's Imbruvica (ibrutinib), which quickly gained traction and achieved significant sales. Imbruvica's success posed a significant challenge to Zydelig, with Imbruvica projected to reach peak sales of $12 billion[1].

Clinical Trials and Safety Concerns

In 2016, Gilead halted six clinical trials of Zydelig due to reports of serious side effects, including multiple deaths among participants. These trials involved previously untreated patients and used Zydelig in combinations not yet approved. While the current FDA-approved indications for Zydelig remained intact, the halt in trials raised red flags about the drug's long-term growth potential, especially since combining drugs is a standard practice in treating these cancers[1].

Financial Impact

The halt in trials and the associated safety concerns had a significant impact on Zydelig's financial trajectory. Despite initial sales of $132 million in 2015, the drug's growth was severely hampered by the negative outcomes of the clinical trials. Analysts noted that these setbacks would likely limit Zydelig's long-term growth, as the drug's potential in combination therapies was a key factor in its projected success[1].

Sales Performance

In the years following its launch, Zydelig's sales did not meet the initial blockbuster expectations. The drug's sales were overshadowed by other products in Gilead's portfolio, such as Veklury (remdesivir) during the COVID-19 pandemic, and other HIV and oncology treatments. For instance, in the full year 2020, other product sales, which include Zydelig, decreased by 18% to $1.9 billion compared to the same period in 2019, primarily due to declines in other products within this category[3].

Current Market Standing

As of recent financial reports, Zydelig is no longer a significant contributor to Gilead's revenue. The company's focus has shifted to other successful products like Biktarvy, Descovy, and cell therapy products such as Yescarta and Tecartus. These products have driven growth in Gilead's HIV and oncology segments, while Zydelig's impact has been marginalized due to its limited use and the absence of new approvals for combination therapies[4].

Analyst Perspectives

Analysts have been clear about Zydelig's diminished prospects. Geoffrey Porges of Leerink Partners noted that the decisions to halt trials and the associated safety concerns effectively meant that "Zydelig is dead in the water"[1]. This sentiment reflects the broader market perception that Zydelig's potential has been significantly curtailed.

Conclusion

Zydelig's story is a cautionary tale of how promising drug launches can be derailed by safety concerns and intense market competition. Despite its initial promise, Zydelig's financial trajectory has been marked by disappointment and limited growth. As Gilead Sciences continues to focus on its more successful and growing product lines, Zydelig remains a footnote in the company's broader portfolio.

Key Takeaways

• Launch and Initial Promise: Zydelig was launched in 2014 with promising data, especially in combination with Rituxan.
• Safety Concerns: Clinical trials were halted in 2016 due to serious side effects and deaths.
• Market Competition: Faced intense competition from Imbruvica and other treatments.
• Financial Impact: Sales did not meet blockbuster expectations; growth was severely hampered.
• Current Standing: No longer a significant contributor to Gilead's revenue.
• Analyst Perspectives: Viewed as having limited prospects due to safety concerns and market competition.

FAQs

Q: What is Zydelig used for? A: Zydelig is used in the treatment of chronic lymphocytic leukemia (CLL), indolent B-cell non-Hodgkin's lymphoma, and small lymphocytic lymphoma (SLL).

Q: Why were clinical trials for Zydelig halted? A: Clinical trials were halted due to reports of serious side effects, including multiple deaths among participants.

Q: How did the halt in trials affect Zydelig's sales? A: The halt in trials significantly limited Zydelig's long-term growth potential, as combination therapies were a key factor in its projected success.

Q: What are some of the competing drugs to Zydelig? A: Notable competitors include Johnson & Johnson and AbbVie's Imbruvica (ibrutinib) and AbbVie's ABT-199.

Q: What is the current market standing of Zydelig? A: Zydelig is no longer a significant contributor to Gilead's revenue, overshadowed by other successful products in the company's portfolio.

Sources

1. FiercePharma - "Zydelig 'dead in the water' after trial deaths force Gilead to stop frontline studies"
2. Biospace - "Gilead Sciences Announces Third Quarter 2023 Financial Results"
3. Gilead Sciences - "Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results"
4. Gilead Sciences - "Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results"