IBRANCE Drug Patent Profile

When do Ibrance patents expire, and when can generic versions of Ibrance launch?

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-six 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 seventeen 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 five 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:	166
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	127
Patent Applications:	4,077
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
AstraZeneca	Phase 1/Phase 2
Relay Therapeutics, Inc.	Phase 1

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.

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	10,723,730		Y	Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019		RX	Yes	No	RE47739		Y	Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015		RX	Yes	No	RE47739		Y	Y

Expired US Patents for IBRANCE

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

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/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 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
Denmark	3431475
Slovenia	2958916
European Patent Office	3302565	FORMES GALÉNIQUES SOLIDES DE PALBOCICLIB (SOLID DOSAGE FORMS OF PALBOCICLIB)

Supplementary Protection Certificates for IBRANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	C01470124/01	Switzerland		PRODUCT NAME: PALBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66138 31.01.2017
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	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 for the Drug: Ibrance

Introduction

Ibrance, also known as palbociclib, is a significant player in the oncology market, particularly for the treatment of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Here, we delve into the market dynamics and financial trajectory of Ibrance, highlighting its performance, challenges, and future outlook.

Mechanism of Action and Clinical Use

Ibrance is a pyridopyrimidine-derived cyclin-dependent kinase (CDK) inhibitor with high anti-neoplastic activity. It works by inhibiting CDK4 and CDK6, which are crucial for cell cycle progression, thereby slowing down the growth of cancer cells. Approved in 2015, Ibrance is administered orally and is sold globally by Pfizer Inc. and its subsidiaries[1][4].

Historical Sales Performance

Ibrance has seen varied sales performance over the years. In 2021, it recorded high-single digit year-on-year growth. However, between 2020 and 2023, the global drug sales of Ibrance experienced a historical decline with a compound annual growth rate (CAGR) of -4.12%. As of 2023, the global sales of Ibrance stood at USD 4,753 million[1].

Market Trends and Competitors

The market for ER+ HER2- breast cancer treatments is dynamic and competitive. Ibrance faces competition from other emerging therapies and drugs. The launch of late-stage emerging therapies in the near future is expected to significantly impact the market, potentially challenging Ibrance's dominance. Companies are developing novel approaches to treat this condition, which could alter the market landscape[4].

Regulatory and Developmental Activities

Ibrance's market performance is also influenced by regulatory milestones and ongoing research and development activities. The drug has undergone extensive clinical trials and has been approved in several countries, including the US, UK, France, Germany, and Japan. Continuous monitoring and updates on regulatory approvals and clinical trials are crucial for its market positioning[4].

Financial Performance of Pfizer

Pfizer's overall financial performance has a direct impact on the sales and revenue generated by Ibrance. In 2023, Pfizer reported full-year revenues of $58.5 billion, a significant decline of 42% compared to 2022, primarily due to lower revenues from Comirnaty and Paxlovid. However, excluding these contributions, Pfizer's revenues grew 7% operationally, indicating a resilient performance of other products like Ibrance[2][5].

Regional Market Analysis

Ibrance's sales are distributed across various regions, including the United States, Europe, and Asia. The drug's performance can vary significantly by region due to differences in healthcare policies, market competition, and patient demographics. For instance, the US market is a significant contributor to Ibrance's global sales, with detailed market forecasts available for this region up to 2032[4].

Impact of External Factors

External factors such as the COVID-19 pandemic have affected the sales trajectories of many drugs, including Ibrance. The pandemic disrupted healthcare systems and altered patient treatment patterns, which could have temporarily impacted Ibrance's sales. However, the long-term impact of such events on Ibrance's market performance needs careful analysis[3].

Future Market Forecast

The future market forecast for Ibrance is complex and influenced by several factors. Despite the current decline, Ibrance is expected to remain a significant player in the ER+ HER2- breast cancer market. However, the launch of new therapies and changes in healthcare spending patterns will shape its market trajectory. Detailed forecasts up to 2032 suggest that while Ibrance will face competition, it will continue to be a vital treatment option[4].

Competitive Landscape

The competitive landscape for ER+ HER2- breast cancer treatments is evolving. Ibrance faces competition from other CDK inhibitors and emerging therapies. Companies are focusing on novel approaches to improve treatment outcomes, which could challenge Ibrance's market share. A comprehensive overview of market competitors and emerging therapies is essential for understanding Ibrance's future market position[4].

SWOT Analysis

A SWOT analysis of Ibrance highlights its strengths, such as its established market presence and clinical efficacy. However, it also reveals weaknesses, including the declining sales trend and increasing competition. Opportunities lie in expanding into new markets and leveraging incremental healthcare spending, while threats include the launch of new therapies and regulatory changes[4].

Analyst Views and Market Insights

Analyst views on Ibrance are mixed, reflecting both the drug's current challenges and its potential for future growth. Market insights suggest that Ibrance will continue to be a key player in the oncology market, but its dominance will be tested by emerging therapies. A detailed analysis of market competitors and future market assessments is crucial for understanding Ibrance's trajectory[4].

Key Takeaways

• Sales Performance: Ibrance experienced a decline in sales between 2020 and 2023, with a CAGR of -4.12%, but it remains a significant player in the ER+ HER2- breast cancer market.
• Market Trends: The market is competitive, with emerging therapies posing a challenge to Ibrance's dominance.
• Regulatory and Developmental Activities: Continuous regulatory updates and research are critical for Ibrance's market positioning.
• Financial Performance: Pfizer's overall financial performance impacts Ibrance's sales, with operational growth seen in other products.
• Future Forecast: Despite current declines, Ibrance is expected to remain vital in the market up to 2032, with competition from new therapies.

FAQs

What is Ibrance used for?

Ibrance (palbociclib) is used for the treatment of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Who manufactures Ibrance?

Ibrance is manufactured and sold by Pfizer Inc. and its subsidiaries.

What is the current sales trend for Ibrance?

As of 2023, Ibrance has experienced a decline in sales with a CAGR of -4.12% between 2020 and 2023, but it still generated USD 4,753 million in global sales.

What are the main challenges facing Ibrance in the market?

Ibrance faces challenges from emerging therapies, changes in healthcare spending, and competition from other CDK inhibitors.

What is the future market forecast for Ibrance?

Despite current declines, Ibrance is expected to remain a significant player in the ER+ HER2- breast cancer market up to 2032, although it will face increasing competition from new therapies.

Sources

1. GlobalData: "The Global Drug sales of Ibrance" (2020-2026)
2. BioSpace: "Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance"
3. NCBI: "MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs"
4. GlobeNewswire: "United States IBRANCE (Palbociclib) Drug Insight and Market Forecasts Report 2023-2032"
5. Pfizer: "Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance"

Last updated: 2024-12-16