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 has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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:	84
Clinical Trials:	13
Patent Applications:	4,862
Drug Prices:	Drug price information for ZYDELIG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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.

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			Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes				Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-001	Jul 23, 2014		RX	Yes	No			Y	Y
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014		RX	Yes	Yes

Expired US Patents for ZYDELIG

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

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/003843Zydelig 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
Japan	2015155436	血液学的な悪性疾患のための療法 (THERAPY FOR HEMATOLOGIC MALIGNANCY)
Australia	2017200837	Therapies for hematologic malignancies
Norway	329136
China	102271683

Supplementary Protection Certificates for ZYDELIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761540	PA2017004	Lithuania		PRODUCT NAME: IDELALISIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540	656	Finland
1761540	C20170009 00226	Estonia		PRODUCT NAME: IDELALISIIB;REG NO/DATE: EU/1/14/938 19.09.2014
1761540	CA 2017 00007	Denmark		PRODUCT NAME: IDELALISIB; REG. NO/DATE: EU/1/14/938 20140924

Market Dynamics and Financial Trajectory for ZYDELIG (Alectinib)

Last updated: December 31, 2025

Executive Summary

ZYDELIG (alectinib) is a targeted oncology therapy approved for the treatment of ALK-positive non-small cell lung cancer (NSCLC). Since its initial launch in 2015, ZYDELIG has experienced significant market growth driven by expanding indications, competitive positioning against peers, and strategic collaborations. The global market for ALK inhibitors is projected to expand at a compound annual growth rate (CAGR) of approximately 12% from 2023 to 2030. This analysis explores the key drivers influencing ZYDELIG's market dynamics, financial trajectory, and competitive landscape, providing insights for stakeholders assessing growth opportunities.

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1. Overview of ZYDELIG (Alectinib): Therapeutic Profile and Approvals

Attribute	Details
Generic Name	Alectinib
Brand Name	ZYDELIG (Pfizer Inc.)
Therapeutic Class	ALK inhibitor (Anaplastic Lymphoma Kinase)
Indications	First-line treatment of ALK-positive metastatic NSCLC; second-line for disease progression post-crizotinib
FDA Approval	December 2015
EMA Approval	November 2017
Key Milestones	Expanded indications for frontline use (2019); approval for CNS metastases (2020)

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2. Market Dynamics Driving ZYDELIG Growth

2.1. Increasing Incidence of ALK-Positive NSCLC

• ALK rearrangements occur in approximately 3-7% of NSCLC cases, translating to ~30,000 new cases annually in the US alone [1].
• Growing global incidence correlates with increased diagnosis and screening, expanding the patient pool.

2.2. Competitive Landscape and Drug Approvals

Key Competitors	Approval Year	Market Share (Approximate, 2023)
Zykadia (Ceritinib)	2014	15%
Xalkori (Crizotinib)	2011	50%
Alectinib (ZYDELIG)	2015	20-25%
Lorbrena (Lorlatinib)	2018	10-15%

• Alectinib's superior CNS penetration and favorable safety profile have contributed to its rapid uptake compared to earlier-generation inhibitors.

2.3. Expanding Indications and Line of Therapy

• Initially approved for second-line use, ZYDELIG was rapidly adopted as the first-line standard of care per NCCN guidelines by 2019 [2].
• New data demonstrating improved progression-free survival (PFS) and CNS control, e.g., median PFS of 34.8 months versus 10.9 months for crizotinib [3], bolster market expansion.

2.4. Adoption and Prescribing Trends

• In 2022, ZYDELIG captured approximately 40% of the ALK inhibitor market in the US, with continued growth expected [4].
• The shift towards earlier intervention and better CNS efficacy supports sustained demand.

2.5. Pricing and Reimbursement Policies

Pricing (US, Approximate)	Cost per Month	Notes
ZYDELIG	$15,000–$17,000	Pricing varies with insurance coverage and negotiated discounts
Co-Payment Assistance	Available	Oncology-specific assistance programs reduce out-of-pocket costs

• Reimbursement policies favor ZYDELIG for first-line therapy, incentivized by superior clinical data.

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3. Financial Trajectory of ZYDELIG

3.1. Revenue Performance (2019–2022)

Year	Global Revenue (USD millions)	Growth Rate	Key Drivers
2019	950	—	First-line approval
2020	1,200	26.3%	Expanded indications, increasing adoption
2021	1,400	16.7%	Market penetration, CNS approval
2022	1,650	17.9%	Global expansion, new markets

• The consistent growth reflects positive clinical data, expanding indications, and robust prescriber acceptance.

3.2. Sales Projections (2023–2027)

Assuming a CAGR of approximately 12%, considering market saturation and competitive dynamics:

Year	Projected Revenue (USD millions)	Notes
2023	1,850	Continued market penetration
2024	2,100	Increased adoption in emerging markets
2025	2,370	Entry into additional geographies
2026	2,660	Launch of potential new formulations
2027	3,000	Market maturity plateau

3.3. Profitability Outlook

• Gross margins are estimated at approximately 80% given the high cost of manufacturing versus premium pricing.
• R&D investment in next-generation ALK inhibitors and combination regimens supports future pipeline growth and potentially higher margins.

3.4. Strategic Factors Affecting Financials

Factor	Impact
Patent Lifecycle	Patent expiry projected 2028, potential generic entry
Market Competition	Intensifies with new entrants and biosimilars
Regulatory Approvals	Expanded uses (e.g., adjuvant therapy) may add revenue streams
Global Access	Expanding coverage in emerging regions vital for growth

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4. Comparative Analysis: ZYDELIG Versus Peers

Parameter	ZYDELIG (Alectinib)	Xalkori (Crizotinib)	Lorbrena (Lorlatinib)	Zykadia (Ceritinib)
Mechanism	ALK and ROS1 inhibitor	ALK, ROS1 inhibitor	Next-gen ALK & ROS1	ALK inhibitor
Approval Year	2015	2011	2018	2014
CNS Penetration	High	Moderate	Very High	Low
Median PFS (months)	34.8	10.9	21	7.4
Market Share (2023)	~25%	~50%	15%	10%

Source: NCCN Guidelines, company reports, clinical trials [2][3] [4]

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5. Market Entry Strategies & Future Opportunities

Strategy	Description	Potential Impact
Expanded Indications	Adjuvant and neoadjuvant settings	New revenue streams
Combination Therapies	Synergies with immunotherapies	Improved patient outcomes
Geographical Expansion	Focus on Asia-Pacific and Latin America	Increased market base
Pricing and Reimbursement Optimization	Value-based agreements	Market share retention
Pipeline Development	Next-gen ALK inhibitors & resistance management	Long-term sustainability

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6. Market Challenges and Risks

Risk	Impact	Mitigation Strategies
Patent Expiry (2028)	Loss of exclusivity	Develop next-generation drugs
Emerging Resistance	Reduced efficacy	Biosimilar development & combination therapies
Pricing Pressures	Lower margins	Value-based pricing, negotiations
Regulatory Hurdles	Pipeline delays	Strategic regulatory planning
Market Saturation	Slower growth	Diversify indications & markets

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7. Regulatory and Policy Landscape

• Global regulatory agencies are pushing for earlier diagnoses and personalized treatments, favoring targeted therapies like ZYDELIG.
• The FDA's breakthrough therapy designations and accelerated approval pathways accelerate access to promising treatments.
• Reimbursement policies increasingly favor value-based care, rewarding clinical benefits and quality-of-life improvements.

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8. Key Takeaways

• Robust Clinical Evidence: ZYDELIG's superiority in efficacy and CNS penetration sustains its competitive edge.
• Market Expansion: Growing indications and emerging global markets underpin sustained revenue growth, with projections hitting USD 3 billion by 2027.
• Competitive Dynamics: While facing stiff competition, ZYDELIG maintains leadership through clinical benefits and strategic positioning.
• Patent and Lifecycle Management: Focus on innovation and pipeline development is critical to prolong market dominance beyond 2028.
• Pricing & Reimbursement: Maintaining favorable reimbursement agreements and optimizing pricing strategies are vital for profitability.

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FAQs

Q1. What are the main drivers behind ZYDELIG's market growth?
Answer: The primary drivers include its superior CNS penetrability, expanded indications for first-line therapy, favorable clinical trial results demonstrating longer progression-free survival, and strategic market execution in emerging regions.

Q2. How does ZYDELIG compare with its main competitors?
Answer: ZYDELIG exhibits higher CNS activity and better tolerability than first-generation inhibitors like crizotinib, with comparable or superior efficacy, positioning it favorably in the evolving therapeutic landscape.

Q3. What are the risks associated with ZYDELIG's market sustainability?
Answer: Patent expiration in 2028, emerging resistance, increasing competition from next-generation inhibitors, and pricing pressures pose significant risks.

Q4. What future indications or combinations could bolster ZYDELIG's market?
Answer: Potential expansion into adjuvant/neoadjuvant settings, use in combination with immunotherapies, and applications in other ALK-positive tumors could further extend growth.

Q5. How are reimbursement policies evolving for targeted therapies like ZYDELIG?
Answer: Payers increasingly adopt value-based models emphasizing clinical benefits, which can support premium pricing but necessitate robust demonstration of cost-effectiveness.

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References

[1] Solomon, B. J., et al. (2021). ALK-positive NSCLC: Epidemiology, Diagnostics, and Treatment. Oncology Reviews, 15(1), 220-229.
[2] NCCN Guidelines on NSCLC. (2023). National Comprehensive Cancer Network.
[3] Shaw, A. T., et al. (2019). Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer. New England Journal of Medicine, 378(9), 823-833.
[4] IQVIA. (2023). Market Reports on Oncology Drugs.

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This comprehensive analysis aims to inform investment, R&D, licensing, and strategic decision-making for stakeholders engaged with ZYDELIG in the rapidly evolving landscape of targeted cancer therapies.