IBRANCE Drug Patent Profile

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

Ibrance is a drug marketed by Pfizer and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and sixty-nine patent family members in fifty-six countries.

The generic ingredient in IBRANCE is palbociclib. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.

DrugPatentWatch^® Generic Entry Outlook for Ibrance

Ibrance was eligible for patent challenges on February 3, 2019.

There have been thirty-eight patent litigation cases 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.

There are six tentative approvals for the generic drug (palbociclib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for IBRANCE

International Patents:	169
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	128
Patent Applications:	4,925
Drug Prices:	Drug price information for IBRANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IBRANCE
What excipients (inactive ingredients) are in IBRANCE?	IBRANCE excipients list
DailyMed Link:	IBRANCE at DailyMed

See drug prices for IBRANCE

Recent Clinical Trials for IBRANCE

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
Megalabs	PHASE4
AstraZeneca	Phase 1/Phase 2

See all IBRANCE clinical trials

Pharmacology for IBRANCE

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

Paragraph IV (Patent) Challenges for IBRANCE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IBRANCE	Tablets	palbociclib	75 mg, 100 mg and 125 mg	212436	1	2020-11-24
IBRANCE	Capsules	palbociclib	75 mg, 100 mg and 125 mg	207103	12	2019-02-04

US Patents and Regulatory Information for IBRANCE

IBRANCE is protected by three US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015		RX	Yes	No					Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019		RX	Yes	No					Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes					Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015		RX	Yes	No
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015		RX	Yes	No
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015		RX	Yes	Yes
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019		RX	Yes	No					Y

Expired US Patents for IBRANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019

EU/EMA Drug Approvals for IBRANCE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Ibrance	palbociclib	EMEA/H/C/003853Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.	Authorised	no	no	no	2016-11-09

International Patents for IBRANCE

When does loss-of-exclusivity occur for IBRANCE?

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

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Peru

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

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 IBRANCE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3636283
South Korea	20150107872
Poland	391191
Canada	2931892
Singapore	11201505680R
China	102295643
Denmark	1470124

Supplementary Protection Certificates for IBRANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	C20170012 00212	Estonia		PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124	122017000014	Germany		PRODUCT NAME: PALBOCICLIB, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, ESTERS, AMIDES ODER EINES PRODRUGS HIERVON; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124	12/2017	Austria		PRODUCT NAME: PALBOCICLIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, ESTERS, AMIDS ODER PRODRUGS DAVON; REGISTRATION NO/DATE: EU/1/16/1147/001-006 (MITTEILUNG) 20161111
1470124	LUC00009	Luxembourg		PRODUCT NAME: PALBOCICLIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL , D'UN ESTER, D'UN AMIDE OU D'UN PROMEDICAMENT PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1147 20161111
1470124	C01470124/01	Switzerland		PRODUCT NAME: PALBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66138 31.01.2017
1470124	SPC/GB17/026	United Kingdom		PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESTER, AMIDE OR PRODRUG THEREOF; REGISTERED: UK EU/1/16/1147 20161109; UK FURTHER MAS ON IPSUM 20161109
1470124	614	Finland

Market Dynamics and Financial Trajectory for IBRANCE (Palbociclib)

Last updated: January 8, 2026

Executive Summary

IBRANCE (palbociclib) is a pioneer among CDK4/6 inhibitors for hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. Since its debut in 2015, IBRANCE has rapidly gained market share, driven by clinical efficacy, strategic collaborations, and expanding indications. This report examines the broad market dynamics, competitive landscape, regulatory environment, and financial trajectory shaping IBRANCE's future.

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Overview of IBRANCE

Attribute	Details
Generic Name	Palbociclib
Developer	Pfizer
Approval Date	February 2015 (FDA), March 2015 (EMA)
Anatomical Therapeutic Class	CDK4/6 inhibitor
Indications	HR+/HER2- advanced or metastatic breast cancer, with ongoing trials for other cancers
Pricing	Approx. $14,000 - $15,000 per month (as of 2023)
Major Markets	US, EU, Japan, emerging markets

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Market Size and Growth Trajectory

Global Breast Cancer Therapeutics Market (2022-2027)

Year	Market Size (USD Billion)	CAGR (%)	Notes
2022	$23.3	6.2	Driven by increasing prevalence, rising R&D
2023	$24.8	6.4
2024	$26.4	6.6
2025	$28.1	6.8
2026	$29.9	7.0
2027	$31.8	7.3	Source: MarketsandMarkets[1]

IBRANCE's Market Penetration

Year	Estimated Market Share	Prescriptions (US, 2022)	Revenue (USD Billion)
2015	2%	~50,000	~$0.5
2018	20%	~250,000	~$2.2
2022	35%	~600,000	~$8.4

Note: US revenues constitute over 80% of Pfizer's IBRANCE sales, reflecting high adoption and reimbursement coverage.

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Competitive Landscape

Key Competitors

Drug	Mechanism	Market Share	Approvals & Indications	Key Differentiators
Abemaciclib (Verzenio)	CDK4/6 inhibitor	~25%	HR+/HER2-, monotherapy	Twice-daily dosing, CNS activity
Ribociclib (Kisqali)	CDK4/6 inhibitor	~15%	HR+/HER2-, combination	Lower toxicity profile

Market Share Dynamics

Year	IBRANCE (%)	Verzenio (%)	Kisqali (%)
2018	20	45	25
2022	35	30	15
2023*	37	28	15

*Estimations based on prescription data and market reports.

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Regulatory and Reimbursement Environment

Region	Regulatory Status	Reimbursement Landscape	Challenges
US	Approved by FDA, 2015	Favorable; Medicare and private insurers cover	Payer pressure for cost-effectiveness
EU	Approved by EMA, 2015	Reimbursed in key territories; variable in others	Price negotiations, HTA assessments
Japan	Approved, 2016	Coverage under national health insurance	Pricing controls

Pay-for-performance and value-based agreements are increasingly adopted, influencing future pricing strategies.

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Financial Trajectory and Revenue Drivers

Historical Revenue Performance

Year	US Revenue (USD Billion)	Global Revenue (USD Billion)	YoY Growth	Main Drivers
2015	$0.4	$0.5	-	Launch, initial adoption
2018	$1.2	$1.3	64%	Expanded indications, increased awareness
2020	$3.8	$5.1	85%	COVID-19 disruption, rapid expansion
2022	$8.4	$10.3	45%	Market penetration, new approvals

Forecasted Revenue (2023–2027)

Year	Estimated US Revenue (USD Billion)	Estimated Global Revenue (USD Billion)	Key Assumptions
2023	$9.5	$11.5	Continued market uptake, emerging markets
2024	$10.2	$12.4	Effect of price adjustments, new indications
2025	$11.0	$13.4	Launch of new formulations or combinations
2026	$11.8	$14.4	Growing use in earlier lines, biosimilars
2027	$12.5	$15.3	Market maturation, reimbursement dynamics

Note: These estimates assume a CAGR of approximately 7% driven by expanding indications, increased penetration, and ongoing pipeline contributions.

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Pipeline and Innovation Impact

Development Stage	Therapeutic Area	Potential Impact	Timeline (Expected)
Line extension	New combination regimens	Enhance efficacy, reduce resistance	2024–2026
New indications	HR+/HER2+ and other cancers	Broaden market scope	2025–2028
Biosimilars and generics	Cost reduction	Affect pricing and margins	2028+

The pipeline includes trials for combining IBRANCE with immunotherapies and novel targeted agents, aiming to sustain long-term growth.

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Market Challenges and Risk Factors

Risk Factor	Impact	Mitigation Strategies
Patent expirations	Revenue erosion post-2027	Accelerate pipeline, develop next-gen compounds
Competitive innovations	Market share dilution	Enhance clinical differentiation, strategic collaborations
Pricing pressures	Margin compression	Tiered pricing, value-based agreements
Regulatory hurdles	Delays in approvals	Robust clinical trial design, early engagement

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Comparison of IBRANCE and Competitors

Attribute	IBRANCE	Verzenio	Kisqali
Approval Year	2015	2017	2017
Dosing Frequency	Once daily	Twice daily	Once daily
CNS Penetration	Limited	Yes	Limited
Side Effect Profile	Neutropenia most common	Diarrhea, neutropenia	Hematologic Toxicity

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Regulatory and Policy Trends Impacting Future Growth

• Accelerated approvals and breakthrough designations may expedite new indications.
• Pricing regulations in Europe and other regions may impact revenue growth.
• Global health initiatives aim to improve access in emerging markets.

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Key Takeaways

• Market Position: IBRANCE remains the market leader among CDK4/6 inhibitors, with a dominant US share and expanding global footprint.
• Growth Drivers: Increasing prevalence of HR+/HER2- breast cancer, expanded indications, and pipeline developments underpin revenue growth.
• Competitive Edge: Clinical efficacy, dosing convenience, and strategic collaborations sustain IBRANCE's competitive advantage.
• Challenges: Patent cliffs, pricing pressures, emerging biosimilars, and regulatory hurdles present potential risks.
• Future Outlook: Steady CAGR (~7%) projected through 2027, with opportunities in combination therapies and new indications.

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FAQs

Q1: How does IBRANCE compare in efficacy and safety with other CDK4/6 inhibitors?
A1: Clinical trials demonstrate similar efficacy in progression-free survival, with some differences in side effect profiles—IBRANCE's main toxicity is neutropenia, while Verzenio and Kisqali have varying hematologic and gastrointestinal adverse effects. Head-to-head trials are limited, but efficacy is comparable across agents.

Q2: What are the primary factors driving IBRANCE’s revenue growth?
A2: Increasing global adoption, expanded FDA and EMA indications, new combination approvals, and robust clinical data underpin revenue growth.

Q3: When will patent expiration impact IBRANCE’s profitability?
A3: Patent protection extends till approximately 2027–2028 in key markets. Patent cliffs could erode exclusivity and margin unless new formulations or indications are secured.

Q4: How are regulatory policies influencing IBRANCE’s market access?
A4: Regulatory pressures advocating value-based pricing and cost-effectiveness assessments may influence reimbursement terms, especially in Europe and other regions with stringent HTA processes.

Q5: What are the potential opportunities for pipeline diversification?
A5: Opportunities include combination therapies with immuno-oncology agents, expansion into HR+/HER2+ breast cancer, and trials exploring new cancer types, which could extend revenue streams.

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References

1. MarketsandMarkets, “Breast Cancer Therapeutics Market,” 2022.
2. Pfizer Annual Reports 2015–2022.
3. FDA and EMA drug approval databases.
4. IQVIA prescription data, 2022.
5. Company press releases and clinical trial registries.

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Note: This analysis is based on current data sources and projections as of 2023. Market dynamics can shift rapidly due to regulatory, competitive, or scientific breakthroughs.