PALBOCICLIB - Generic Drug Details

What are the generic drug sources for palbociclib and what is the scope of freedom to operate?

Palbociclib is the generic ingredient in two branded drugs marketed by Pfizer and Zydus Lifesciences, and is included in three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are thirteen drug master file entries for palbociclib. Two suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for PALBOCICLIB

International Patents:	169
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	323
Patent Applications:	7,774
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PALBOCICLIB
What excipients (inactive ingredients) are in PALBOCICLIB?	PALBOCICLIB excipients list
DailyMed Link:	PALBOCICLIB at DailyMed

Recent Clinical Trials for PALBOCICLIB

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

Sponsor	Phase
Pfizer	PHASE2
Stephanie Berg	PHASE2
West China Hospital	PHASE2

See all PALBOCICLIB clinical trials

Generic filers with tentative approvals for PALBOCICLIB

Applicant	Application No.	Strength	Dosage Form
		125MG	CAPSULE;ORAL
		100MG	CAPSULE;ORAL
		125MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PALBOCICLIB

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

Anatomical Therapeutic Chemical (ATC) Classes for PALBOCICLIB

L01EF	Cyclin-dependent kinase (CDK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PALBOCICLIB

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 PALBOCICLIB

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	207103-002	Feb 3, 2015		RX	Yes	No					Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes					Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015		RX	Yes	No					Y

Expired US Patents for PALBOCICLIB

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	CAPSULE;ORAL	207103-002	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015

EU/EMA Drug Approvals for PALBOCICLIB

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 PALBOCICLIB

Country	Patent Number	Title	Estimated Expiration
Georgia, Republic of	P20063909	2-(PYRIDIN-2-YLAMINO)-PYRIDO[2,3d] PYRIMIDIN-7-ONES
Taiwan	I633103
Serbia	59672

Supplementary Protection Certificates for PALBOCICLIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	17C1012	France		PRODUCT NAME: PALBOCICLIB, ET TOUTES SES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE.; REGISTRATION NO/DATE: EU/1/16/1147 20161109

Market Dynamics and Financial Trajectory for Palbociclib: A Strategic Overview

Last updated: November 14, 2025

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Introduction

Palbociclib (brand name Ibrance™) stands as a pivotal development in targeted cancer therapy, particularly for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Since its FDA approval in 2015, palbociclib has significantly influenced treatment paradigms, showcasing robust market growth and reshaping the pharmaceutical landscape. This analysis explores the underlying market dynamics, anticipated financial trajectories, competitive landscape, and strategic opportunities surrounding palbociclib.

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Market Overview and Market Size

The global breast cancer therapeutics market, estimated at forecasted revenues of approximately USD 22 billion in 2023, continues to expand driven by increasing incidence, advances in targeted therapies, and improved diagnostics. Palbociclib, as a frontline treatment, commands a substantial market share within CDK4/6 inhibitors, a class that includes ribociclib and abemaciclib.

The CDK4/6 inhibitor segment alone is projected to grow at a CAGR of approximately 27% between 2022 and 2028, attributable to the escalating prevalence of HR+/HER2- breast cancer, especially among aging populations, and the emergence of combination therapies enhancing efficacy.

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Market Drivers

1. Rising Incidence of HR+/HER2- Breast Cancer:
Breast cancer remains the most diagnosed cancer worldwide, with HR+ subtypes constituting roughly 70% of cases. The aging global population, coupled with lifestyle factors such as obesity and sedentary habits, amplifies the projected incidence, catalyzing demand for targeted treatments like palbociclib.

2. Proven Clinical Efficacy and Expanded Indications:
Palbociclib’s efficacy in prolonging progression-free survival (PFS) and improving quality of life has solidified its frontline status. Clinical trials, including PALOMA series studies, demonstrate statistically significant benefits, prompting regulatory expansions into earlier lines of therapy and adjuvant settings.

3. Strategic Partnerships and Market Penetration:
AbbVie (original developer) and its marketing partner Pfizer have implemented aggressive marketing and distribution strategies, expanding access in emerging markets. Collaborations with local healthcare providers and inclusion in treatment guidelines boost sales volume.

4. Competitive Dynamics and Other CDK4/6 Inhibitors:
Despite intense competition from ribociclib (Kisqali) and abemaciclib (Verzenio), palbociclib retains a competitive edge through early market entry, extensive real-world data, and proven safety profile. However, competitive pricing and regulatory endorsements continuously influence market share.

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Market Challenges

1. Patent Expirations and Biosimilar Entry:
Patent exclusivity for palbociclib is expected to expire by 2028-2030 in key markets, opening avenues for biosimilar entrants. This will likely precipitate price reductions and sharpen generic competition, impacting revenue streams.

2. High Cost of Therapy:
Palbociclib’s treatment cost remains high, limiting accessibility in developing regions. Reimbursement policies vary, influencing adoption rates and profitability.

3. Regulatory Hurdles and Off-Label Use:
Regulatory approvals for expanded indications and off-label use pose challenges related to safety and efficacy assessments, potentially impacting market dynamics.

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Financial Trajectory

Current Revenue and Growth Trends:
In 2022, palbociclib generated revenues exceeding USD 4 billion globally, with sales growth primarily driven by North America and Europe. The compound annual growth rate (CAGR) from 2015 to 2022 has been approximately 22%, reflecting rapid adoption and expanding indications.

Projection Roadmap (2023-2028):
Forecasts suggest that palbociclib's global sales could approach USD 8-10 billion by 2028 if market expansion continues smoothly. Key drivers include:

• Uptake in first- and second-line settings.
• Approval for early-stage and adjuvant applications.
• Increase in prescriber adoption driven by updated clinical guidelines.

Impact of Patent Expiration:
Anticipated patent cliffs could trigger a 20-30% decline in revenues from 2028 onward, unless offset by biosimilar competition or formulary shifts to newer combination therapies with improved efficacy and safety profiles.

Pricing Strategies and Market Access:
Strategic pricing, differential regional pricing, and value-based reimbursement negotiations will influence revenue trajectory. Emerging markets may see lower prices, tempering global growth but expanding patient access.

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Competitive and Regulatory Landscape

1. Competitors:
Ribociclib and abemaciclib possess similar indications with nuanced efficacy and side-effect profiles. Market share distribution shifts as evidence accumulates and head-to-head trials commence. As of 2023, palbociclib commands approximately 40-45% of the CDK4/6 segment.

2. Regulatory Developments:
The FDA and EMA continue to approve label expansions, including use in adjuvant and early-stage settings. Ongoing post-marketing studies and real-world evidence bolster regulatory confidence and may influence future indications.

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Strategic Opportunities

1. Line Extension and Combination Therapies:
Pipeline advancements exploring palbociclib in combination with immunotherapies or targeted agents of novel pathways (e.g., PI3K inhibitors) could unlock additional markets.

2. Biosimilar Development:
Timely entry of biosimilars (anticipated post-2030 in major markets) presents revenue erosion risks but also opportunities for price Competition and broader market penetration if managed proactively.

3. Geographic Expansion:
Targeted strategies to penetrate emerging markets through partnerships, local manufacturing, and tailored pricing could sustain long-term growth.

4. Personalized Medicine and Companion Diagnostics:
Leveraging genomic and biomarker-driven approaches enhances patient selection, driving higher success rates and optimizing resource allocation.

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Conclusion

Palbociclib’s market position as a leading CDK4/6 inhibitor remains robust amid evolving therapeutic and regulatory landscapes. While growth prospects are promising through expanded indications and geographic expansion, imminent patent expirations pose revenue risks. Strategic adaptation — including biosimilar competition preparedness, pipeline development, and personalized therapeutics — will determine long-term financial trajectory.

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Key Takeaways

• Market Growth: The global CDK4/6 inhibitor segment, led by palbociclib, is projected to grow at a CAGR of approximately 27% through 2028, driven by rising breast cancer incidence and clinical efficacy.
• Revenue Outlook: Palbociclib’s sales are forecasted to reach USD 8–10 billion by 2028, contingent upon continued adoption and regulatory approvals.
• Patent Cliff Risks: Patent expirations beginning around 2028 will introduce biosimilar competition, necessitating strategic pricing and innovation.
• Competitive Landscape: Market share will be influenced by emerging competitors, updated clinical evidence, and combination therapy efficacy.
• Strategic Focus: Opportunities include pipeline expansion, emerging market penetration, and leveraging personalized medicine to enhance market expenditure.

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FAQs

Q1: When will palbociclib face patent expiration, and how will it affect the market?
A: Patent exclusivity in key markets is expected to expire around 2028-2030, leading to biosimilar competition, price reductions, and potential revenue declines.

Q2: What are the key drivers behind palbociclib’s sales growth?
A: Increasing incidence of HR+/HER2- breast cancer, proven clinical efficacy, expanded indications, and strategic market penetration are primary contributors.

Q3: How does palbociclib compare to its competitors?
A: Palbociclib was the first CDK4/6 inhibitor approved, offering a proven safety profile and extensive clinical data, maintaining a strong market position despite competition from ribociclib and abemaciclib.

Q4: What opportunities exist for expanding palbociclib’s market?
A: Opportunities include pipeline development in early-stage breast cancer, combination with novel therapies, biosimilar entry, and geographic expansion into emerging markets.

Q5: How will regulatory changes impact palbociclib’s future?
A: Regulatory endorsements for new indications and ongoing post-marketing data can facilitate broader adoption, while patent expirations may prompt pricing and strategic realignment.

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Sources:

1. Global Oncology Market Report 2023, IQVIA.
2. Palbociclib (Ibrance) Clinical Data, Pfizer & AbbVie reports.
3. Breast Cancer Therapeutics Market Analysis, MarketsandMarkets, 2023.
4. FDA Approval Announcements, U.S. Food and Drug Administration.
5. Market Dynamics of CDK4/6 Inhibitors, GlobalData Healthcare, 2022.