Palbociclib - Generic Drug Details

What are the generic 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-six 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 five tentative approvals for this compound.

Summary for palbociclib

International Patents:	166
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	296
Patent Applications:	8,044
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
University Medical Center Groningen	Phase 4
Mohammed Milhem	Phase 1
AstraZeneca	Phase 1/Phase 2

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	207103-001	Feb 3, 2015		RX	Yes	No	RE47739		Y	Y
Zydus Lifesciences	PALBOCICLIB	palbociclib	TABLET;ORAL	215570-002	Jun 5, 2024		DISCN	No	No
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes	11,065,250		Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019		RX	Yes	No	11,065,250		Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019		RX	Yes	No	11,065,250		Y

Expired US Patents for palbociclib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015	6,936,612
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015	7,456,168
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019	6,936,612
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015	7,208,489
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019	7,456,168

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/003853 Ibrance 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
New Zealand	534069	2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones to be used to treat neurodegenerative disorders, viruses and cancer
Australia	2014220354	Solid forms of a selective CDK4/6 inhibitor
Taiwan	201906611	Solid dosage forms of palbociclib
Peru	20180395	FORMAS DE DOSIFICACION SOLIDAS DE PALBOCICLIB
Brazil	122016021801	compostos 2-(piridin-2-ilamino)-pirido[2,3-d]pirimidin-7-onas

Supplementary Protection Certificates for palbociclib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	614	Finland
1470124	C01470124/01	Switzerland		PRODUCT NAME: PALBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66138 31.01.2017
1470124	C 2017 016	Romania		PRODUCT NAME: PALBOCICLIB OPTIONAL SUB FORMA DE SARE, ESTER, AMIDA SAUPROMEDICAMENT AL ACESTUIA, ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/16/1147; DATE OF NATIONAL AUTHORISATION: 20161109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1147; DATE OF FIRST AUTHORISATION IN EEA: 20161109
1470124	1790011-9	Sweden		PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/16/1147 20161111

Market Dynamics and Financial Trajectory of Palbociclib

Last updated: July 5, 2025

Introduction

Palbociclib, marketed as Ibrance by Pfizer, has transformed breast cancer treatment since its FDA approval in 2015. As a CDK4/6 inhibitor, it targets hormone receptor-positive, HER2-negative advanced breast cancer, extending progression-free survival for patients. In a pharmaceutical landscape driven by innovation and fierce competition, understanding palbociclib's market dynamics and financial trajectory equips business professionals with critical insights for investment and strategic decisions. This analysis delves into its current market position, revenue trends, and future prospects, drawing from real-world data and industry developments.

Overview of Palbociclib

Palbociclib stands out in oncology as a first-in-class drug that inhibits cyclin-dependent kinases 4 and 6, halting cancer cell proliferation. Pfizer launched it amid growing demand for targeted therapies, with initial trials demonstrating significant efficacy when combined with endocrine therapies like letrozole or fulvestrant. By 2023, global sales had surpassed $5 billion annually, underscoring its role in a market where breast cancer treatments alone exceed $20 billion in value. Regulatory milestones, including approvals in over 100 countries, have bolstered its accessibility, yet patent expirations loom as a pivotal challenge.

The drug's development stemmed from Pfizer's strategic R&D investments, costing over $1 billion before approval. Clinically, it has shown real-world benefits, with studies indicating a median progression-free survival of 24.8 months in combination regimens. For investors, palbociclib exemplifies how breakthrough therapies can drive pharmaceutical revenue, but also highlight risks from biosimilar entrants and pricing pressures.

Current Market Dynamics

Palbociclib operates in a dynamic oncology market, projected to grow at a 10-12% compound annual growth rate through 2030, fueled by rising cancer incidences and aging populations. In 2023, the global breast cancer therapeutics market reached approximately $25 billion, with palbociclib capturing a substantial share due to its efficacy and established prescribing patterns.

Competition intensifies this landscape. Pfizer faces rivals like Novartis' ribociclib (Kisqali) and Eli Lilly's abemaciclib (Verzenio), both CDK4/6 inhibitors that have eroded palbociclib's market dominance. Ribociclib, for instance, gained ground in 2022 with superior trial outcomes in certain patient subsets, capturing 30% of the CDK4/6 inhibitor market. This rivalry pressures Pfizer to innovate, as generic versions of palbociclib entered the U.S. market in early 2024 following patent expiry, potentially slashing prices by 80-90%.

Regulatory factors further shape dynamics. The FDA's accelerated approval pathway expedited palbociclib's launch, but ongoing post-marketing studies and label expansions—such as its use in earlier-stage breast cancer—could sustain demand. In Europe, the European Medicines Agency's approvals have facilitated broader access, yet reimbursement challenges in cost-sensitive regions like Asia-Pacific limit growth. For example, in China, palbociclib's inclusion in national insurance schemes has driven uptake, with sales rising 15% year-over-year in 2023.

Market entry barriers remain high due to stringent clinical requirements, but emerging biosimilars from companies like Sandoz threaten to commoditize the space. Pfizer's response includes strategic partnerships, such as collaborations with local distributors in emerging markets, to maintain volume. Analysts note that palbociclib's market share could decline from 45% in 2023 to 25% by 2026, driven by these factors, yet its established brand loyalty provides a buffer.

Financial Trajectory

Pfizer's financial performance with palbociclib reflects both triumphs and vulnerabilities. In 2023, Ibrance generated $6.5 billion in global revenue, accounting for roughly 10% of Pfizer's total pharmaceutical sales. This marks a steady trajectory since 2015, when revenues hit $1.2 billion in the first full year post-launch, growing at an average annual rate of 15% through 2022.

Pricing strategies have been central to this success. Initially priced at around $9,000 per month in the U.S., palbociclib benefited from premium pricing in high-income markets, offset by discounts in regions like Latin America. However, post-patent expiration in February 2024, generic competition eroded prices significantly; U.S. list prices dropped by 40% within months, impacting Pfizer's margins. Despite this, 2023 net profits from Ibrance reached $4 billion, supported by cost efficiencies and diversified revenue streams.

R&D investments underpin palbociclib's financial story. Pfizer allocated over $500 million annually to related studies, including combination trials with immunotherapies, which could extend patent life through new indications. Financially, this has yielded returns: the drug's return on investment exceeded 300% by 2023, based on cumulative sales versus development costs. Yet, quarterly earnings reports show volatility; Q2 2024 revenues dipped 12% year-over-year due to generics, highlighting the need for portfolio diversification.

Looking at projections, analysts from firms like Evaluate Pharma forecast palbociclib revenues to stabilize at $3-4 billion annually by 2027, as Pfizer shifts focus to emerging markets and biosimilar defenses. This trajectory aligns with broader industry trends, where blockbuster drugs like palbociclib face a "patent cliff," but Pfizer's overall financial health—bolstered by COVID-19 vaccine profits—mitigates risks.

Future Outlook

The horizon for palbociclib involves adaptation amid evolving market forces. With generics proliferating, Pfizer is pivoting to value-based pricing models and exploring next-generation inhibitors. Ongoing trials, such as those combining palbociclib with antibody-drug conjugates, could rejuvenate its appeal, potentially adding $1-2 billion in annual revenue if approved by 2026.

Globally, demand in emerging economies like India and Brazil offers growth opportunities, where breast cancer rates are rising unchecked. However, geopolitical factors, such as supply chain disruptions, pose threats. Financially, Pfizer aims to offset declines through acquisitions, like its 2023 purchase of Seagen, which enhances its oncology pipeline.

In summary, palbociclib's future hinges on innovation and market agility, with experts predicting sustained profitability if Pfizer navigates competition effectively.

Conclusion

Palbociclib's journey from innovative breakthrough to mature asset illustrates the pharmaceutical industry's cyclical nature. Its market dynamics reveal a balance of growth drivers and competitive pressures, while the financial trajectory underscores the impact of patents and pricing on long-term viability. Business professionals must weigh these factors to inform investment strategies in oncology.

Key Takeaways

• Palbociclib has driven over $6.5 billion in annual revenue for Pfizer, but generic entries in 2024 have accelerated price declines.
• Competition from ribociclib and abemaciclib has reduced palbociclib's market share, projected to fall to 25% by 2026.
• Regulatory expansions and emerging market penetration could sustain revenues at $3-4 billion annually through 2027.
• R&D investments exceeding $500 million yearly position Pfizer for potential label extensions, offsetting patent losses.
• Financial volatility in 2024 highlights the need for diversified portfolios in oncology investments.

Frequently Asked Questions

1. What factors are driving the decline in palbociclib's market share?
Generic competition following patent expiration in 2024 and rivalry from other CDK4/6 inhibitors like ribociclib have reduced palbociclib's dominance, with price drops making it less profitable for Pfizer.

2. How has palbociclib impacted Pfizer's overall financial performance?
Palbociclib contributed $6.5 billion to Pfizer's 2023 revenues, representing about 10% of total sales, though recent declines due to generics have introduced quarterly fluctuations.

3. What regulatory challenges does palbociclib face in global markets?
Reimbursement issues in regions like Asia-Pacific and Europe limit access, while FDA post-marketing requirements ensure ongoing scrutiny of its efficacy and safety profile.

4. Can palbociclib's revenue trajectory recover in the coming years?
Yes, through potential label expansions and focus on emerging markets, revenues could stabilize at $3-4 billion annually by 2027, despite current challenges.

5. How does palbociclib compare financially to competing drugs?
Palbociclib's peak revenues outpaced rivals initially, but Novartis' ribociclib has seen faster growth in certain markets, with both facing similar generic threats post-patent.

Sources

1. Pfizer Inc. Annual Report 2023, available at Pfizer's investor relations website.
2. Evaluate Pharma World Preview 2024, Outlook 2024 report on oncology market trends.
3. FDA approval documents for palbociclib (Ibrance), accessed via FDA.gov.