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-six 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	TABLET;ORAL	212436-002	Nov 1, 2019
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	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
Poland	3302565
Portugal	2958916
Mexico	363715
Poland	218692
South Korea	102068423
Lithuania	3302565
Iceland	2423

Supplementary Protection Certificates for IBRANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2017/009	Ireland		PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESTER, AMIDE OR PRODRUG THEREOF; REGISTRATION NO/DATE: EU/1/16/1147/001 EU/1/16/1147/006 20161109
1470124	PA2017013	Lithuania		PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124	C20170012 00212	Estonia		PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124	132017000046148	Italy		PRODUCT NAME: PALBOCICLIB, OPZIONALMENTE NELLA FORMA DI UN SALE, ESTERE, AMMIDE O PROFARMACO FARMACEUTICAMENTE ACCETTABILE(IBRANCE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1147/001-006, 20161111
1470124	333 9-2017	Slovakia		PRODUCT NAME: PALBOCIKLIB; REGISTRATION NO/DATE: EU/1/16/1147 20161111
1470124	CR 2017 00010	Denmark		PRODUCT NAME: PALBOCICLIB, EVENTUELT I FORM AF EN FARMACEUTISK ACCEPTABEL ESTER ELLER ET FARMACEUTISK ACCEPTABELT SALT, AMID ELLER PRODRUG; REG. NO/DATE: EU/1/16/1147/001-006 20161111

Market Dynamics and Financial Trajectory for IBRANCE

Last updated: November 7, 2025

Introduction

IBRANCE (palbociclib) stands as a pivotal product in the evolving landscape of oncology therapeutics, primarily used for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Since its FDA approval in 2015, IBRANCE has significantly reshaped treatment algorithms, influencing market dynamics and financial forecasts within the oncology sphere. Analyzing its current position and future trajectory requires an understanding of its clinical profile, competitive landscape, regulatory environment, and emerging market trends.

Clinical and Regulatory Milestones

Approved initially for advanced breast cancer, IBRANCE's indications have expanded to include early-stage disease and combination regimens, solidifying its role as a foundational CDK4/6 inhibitor. Comprehensive clinical trial data demonstrate substantial progression-free survival benefits, enabling its broad adoption among oncologists. Regulatory agencies globally have granted approvals, including in Europe and other key markets, fostering international commercialization and revenue generation.

Market Dynamics

Growing Incidence and Unmet Medical Needs

Breast cancer remains the most diagnosed cancer globally, with over 2 million new cases annually [1]. The subset of hormone receptor-positive, HER2-negative metastatic breast cancer (HR+/HER2-) accounts for approximately 60-70% of cases. An aging population and increased screening population contribute to higher diagnosed incidences, underpinning a sustained demand for effective therapies. As a result, IBRANCE continues to benefit from the expanding patient pool.

Competitive Landscape

IBRANCE faces competition primarily from other CDK4/6 inhibitors—namely, Kisqali (ribociclib) and Verzenio (abemaciclib)—which similarly target HR+/HER2- breast cancer. While efficacy profiles are comparable, differences in side effect profiles, dosing schedules, and clinical trial results influence prescribing patterns. The entry of generics post-expiry of key patents could further intensify price competition and market penetration.

Pricing and Reimbursement Dynamics

Pricing strategies, reimbursement policies, and health insurance coverage significantly impact IBRANCE’s market access. In major markets like the US and EU, the manufacturer’s negotiations with payers influence sales. Value-based pricing models and cost-effectiveness evaluations shape future reimbursement landscapes, especially as biosimilar competition emerges.

Technological and Scientific Trends

Advances in companion diagnostics, such as predictive biomarkers, continuously refine patient selection, improving treatment outcomes and cost-effectiveness. Simultaneously, combination regimens pairing IBRANCE with other targeted agents or immunotherapies may expand the drug’s utility and market size.

Financial Trajectory

Historical Revenue and Market Penetration

Since its launch, IBRANCE has exhibited robust revenue growth. Pfizer, its initial marketer, reported approximately $4.7 billion in worldwide sales during 2022, reflecting rapid adoption and significant market share [2]. The drug dominates in the US, where payers favor its demonstrated efficacy and safety profile, supported by extensive clinical data and guidelines endorsing its use.

Forecasted Growth

Analysts project continued growth, driven by multiple factors:

• Market Expansion: Entry into early breast cancer treatment and additional line indications.
• Global Reach: Regulatory approvals in emerging markets are unlocking new revenue streams.
• Pipeline and Combinations: Investigational studies with other agents could broaden indications, enhancing sales.
• Patent Expiry and Biosimilar Competition: Patent lapses in key regions forecast potential revenue erosion, unless offset by new formulations or indications.

Industry forecasts suggest the global IBRANCE market could reach over $8 billion annually by 2025, with a compounded annual growth rate (CAGR) of approximately 10-12% over the next three years [3].

Risks and Challenges

Financial outlooks must consider the impact of biosimilars, pricing pressures, and regulatory hurdles. Furthermore, the emergence of resistance mechanisms and variability in clinical adoption may temper growth trajectories.

Market Drivers and Limiters

Key Drivers

• Increasing global breast cancer incidence
• Broadening indications in early-stage disease
• Adoption of personalized medicine approaches
• Strategic collaborations for pipeline expansion

Limiting Factors

• Patent expiration and generic entry
• Cost containment policies
• Competitive pressure from other CDK4/6 inhibitors
• Regulatory challenges in expanding use

Conclusion: Future Outlook

IBRANCE’s market dynamics will remain shaped by its rapid clinical adoption, expanding indications, and competitive landscape. Financial prospects remain promising, contingent on successful pipeline development, market expansion, and navigating biosimilar entrants. The trend towards personalized oncology and combination therapies will likely sustain its relevance, albeit at potentially moderated growth rates due to patent expirations and pricing pressures.

Key Takeaways

• Market Expansion: IBRANCE is poised for growth through new indications, especially in early breast cancer and combination therapies.
• Competitive Environment: Its market shares are challenged by rival CDK4/6 inhibitors and future biosimilar entrants, impacting pricing and revenue.
• Global Opportunities: Emerging markets offer substantial revenue opportunities with regulatory approvals and market access strategies.
• Pipeline and Innovation: Ongoing clinical trials may introduce next-generation formulations and novel combinations, safeguarding long-term relevance.
• Regulatory and Economic Factors: Policy shifts toward cost containment may influence reimbursement and pricing strategies, impacting profitability.

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FAQs

Q1: How does IBRANCE compare to its competitors in terms of efficacy?

A1: Clinical trials show comparable efficacy among CDK4/6 inhibitors like IBRANCE, Kisqali, and Verzenio in extending progression-free survival in HR+/HER2- breast cancer. Differences lie in side effect profiles, dosing schedules, and specific patient subgroups.

Q2: What is the expected timeline for patent expiration and biosimilar entry?

A2: Patent exclusivity in key markets is expected to expire around 2027-2029. Biosimilar development is advancing, with some candidates likely to enter the market within this timeframe, potentially impacting prices and sales.

Q3: How are regulatory pathways influencing IBRANCE’s market growth?

A3: Regulatory agencies are increasingly approving expanded indications based on robust clinical data, facilitating market penetration in different stages of breast cancer treatment and boosting sales.

Q4: What strategic approaches could Pfizer employ to sustain IBRANCE’s market position?

A4: Strategies include expanding indications, fostering combination therapies, entering emerging markets, optimizing pricing and reimbursement negotiations, and investing in pipeline development.

Q5: How does the COVID-19 pandemic influence IBRANCE’s market and sales trajectory?

A5: Disruptions in healthcare access temporarily hindered treatment initiation and monitoring. However, the ongoing demand for effective cancer therapies and adaptation to remote clinical practices support long-term market recovery and growth.

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References

[1] World Health Organization. (2022). Global Cancer Statistics 2022.

[2] Pfizer Annual Report 2022. Pfizer Inc.

[3] MarketWatch. (2023). Oncology Drugs Market Growth Forecasts and Trends.