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 Synthon Pharms Inc, 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:	3,469
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	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes	10,723,730		Y	Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019		RX	Yes	No	11,065,250		Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015		RX	Yes	Yes	RE47739		Y	Y
Synthon Pharms Inc	PALBOCICLIB	palbociclib	TABLET;ORAL	215570-002	Jun 5, 2024		DISCN	No	No
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015		RX	Yes	Yes	10,723,730		Y	Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015		RX	Yes	No	RE47739		Y	Y

Expired US Patents for palbociclib

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
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015	7,208,489
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019	7,456,168
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015	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
Tunisia	SN04126	2-(PYRIDINE-2-YLAMINO)-PYRIDO[2,3D] PYRIMIDINE-7-ONES
Denmark	2958916
Denmark	3302565
Israel	255632	צורות מתן מוצקות של פלבוציקליב (Solid dosage forms of palbociclib)
Malaysia	134818	2-(PYRIDIN-2-YLAMINO)-PYRIDO[2,3-d]PYRIMIDIN-7-ONES
South Korea	20200006633	팔보시클립의 고체 투여 형태 (SOLID DOSAGE FORMS OF PALBOCICLIB)

Supplementary Protection Certificates for palbociclib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	PA2017013,C1470124	Lithuania		PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
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	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	614	Finland
1470124	CA 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
1470124	C20170012 00212	Estonia		PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016

The Palbociclib Drug Market: Dynamics and Financial Trajectory

Market Overview

The palbociclib drug market is a significant segment within the pharmaceutical industry, particularly in the realm of oncology. Palbociclib, a CDK4/6 inhibitor, is primarily used to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Rising Incidence of Breast Cancer

Breast cancer is one of the most common cancers affecting women worldwide, accounting for a substantial portion of new cancer cases annually. The increasing incidence of breast cancer, especially aggressive forms, highlights the need for advanced and targeted treatment options like palbociclib[1][3].

Demand for Targeted Therapies

The demand for targeted cancer therapies is on the rise, driven by the need for more effective and less invasive treatments. Palbociclib, by specifically targeting cell cycle proteins to prevent cancer cell growth, offers a more targeted approach than traditional chemotherapy, resulting in improved patient outcomes and quality of life[1].

Market Size and Growth Projections

The global palbociclib drug market is valued at significant figures and is expected to grow substantially in the coming years. For instance, the CDK4/6 inhibitor drugs market, which includes palbociclib, was valued at USD 10.55 billion in 2023 and is projected to exceed USD 79.41 billion by 2036, growing at a CAGR of over 16.8% during the forecast period[3].

Key Drivers of Market Growth

Several factors are driving the growth of the palbociclib market:

Increasing R&D Spending

Investment in research and development activities is crucial for the advancement of palbociclib and other CDK4/6 inhibitors. This spending is expected to increase, driven by the growing need for innovative cancer treatments[1][3].

Regulatory Support

Regulatory support for new drug approvals and favorable reimbursement policies in many developed regions are significant drivers. These factors contribute to the market's expansion and attractiveness to investors[1].

Strategic Partnerships and Collaborations

Strategic partnerships among pharmaceutical companies, research institutions, and biotech firms are accelerating the development of new formulations and expanding the drug's application across more cancer types. Recent mergers and acquisitions have also strengthened the presence of larger pharmaceutical companies in the targeted therapy market[1].

Cost-Effectiveness and Economic Evaluation

Despite its effectiveness, the cost-effectiveness of palbociclib is a critical consideration. Studies have shown that, at current prices, palbociclib and other CDK4/6 inhibitors are not cost-effective when compared to traditional treatments like letrozole alone, assuming a willingness-to-pay threshold of $100,000 per quality-adjusted life-year (QALY) gained. For these drugs to be cost-effective, their prices would need to decrease significantly[2].

Clinical Outcomes and Real-World Data

Real-world data and clinical trials have demonstrated favorable outcomes for patients treated with palbociclib. For example, a study in Argentina showed high progression-free survival rates and overall survival rates for patients treated with palbociclib plus letrozole or fulvestrant[5].

Investment Outlook

The palbociclib market is viewed as an attractive investment opportunity due to its critical role in cancer treatment and promising growth prospects. The market's expansion, driven by increasing cancer rates, demand for precision therapies, and ongoing R&D advancements, makes it a sector with potential for significant returns[1].

Challenges and Mitigants

While the palbociclib market faces challenges such as high treatment costs and competition from other CDK4/6 inhibitors, these are likely to be mitigated by ongoing research and the expanding demand for targeted cancer treatments. Innovations in combination therapies and advancements in genomic testing are also expected to drive market growth[1].

Regional Market Dynamics

The CDK4/6 inhibitor market, including palbociclib, is expected to witness strong growth in various regions. North America is poised to dominate the market, with a significant revenue share by 2036, driven by the increasing number of clinical trials and the high prevalence of breast cancer in the region[3].

Key Players

The palbociclib market is dominated by several key players, including Pfizer, Beacon Pharmaceuticals, Incepta Pharmaceuticals, Bluepharma, and NANO DARU. These companies are involved in various strategic partnerships and research initiatives to further develop and distribute palbociclib[4].

Future Outlook

The future of palbociclib in the oncology space looks promising, with potential applications in treating other cancer types and further advancements in combination therapies. As research expands into other forms of cancer and new drug formulations emerge, the palbociclib market is expected to continue its upward trajectory, transforming cancer treatment on a global scale[1].

Combination Therapies and Immunotherapies

Research into combination therapies, including those with immunotherapies, is opening new pathways for palbociclib’s application in oncology. These innovations are expected to extend survival rates and improve outcomes for breast cancer patients[1].

Genomic Testing

Advancements in genomic testing are helping to identify patients who would benefit most from palbociclib, further personalizing cancer treatment and enhancing the drug's effectiveness[1].

Conclusion

The palbociclib drug market is poised for remarkable growth due to its effectiveness in targeted cancer therapy, innovative research developments, and a global demand for better cancer treatment options. With a promising outlook for both patients and investors, the palbociclib market is set to be a transformative force in the future of oncology.

Key Takeaways

• Rising Incidence of Breast Cancer: Increasing breast cancer rates drive the demand for targeted therapies like palbociclib.
• Market Growth: The market is expected to grow significantly, driven by R&D spending, regulatory support, and strategic partnerships.
• Cost-Effectiveness: Current prices make palbociclib less cost-effective, but potential price reductions could change this.
• Clinical Outcomes: Real-world data show favorable outcomes for patients treated with palbociclib.
• Investment Outlook: The market offers attractive investment opportunities due to its growth prospects.
• Regional Dynamics: North America is expected to dominate the market, with significant revenue share by 2036.
• Future Outlook: The market is expected to continue growing with advancements in combination therapies and genomic testing.

FAQs

Q: What is palbociclib used for?

A: Palbociclib is used primarily to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Q: What are the key drivers of the palbociclib market growth?

A: Key drivers include increasing R&D spending, regulatory support, strategic partnerships, and the growing demand for targeted cancer therapies.

Q: Is palbociclib cost-effective at current prices?

A: No, at current prices, palbociclib is not cost-effective when compared to traditional treatments, assuming a willingness-to-pay threshold of $100,000 per QALY gained[2].

Q: Who are the main players in the palbociclib market?

A: The main players include Pfizer, Beacon Pharmaceuticals, Incepta Pharmaceuticals, Bluepharma, and NANO DARU[4].

Q: What are the future prospects for the palbociclib market?

A: The market is expected to continue growing with potential applications in treating other cancer types and advancements in combination therapies and genomic testing[1].

Sources

1. Market Research Intellect: Palbociclib Drug Market Gains Momentum Transforming Breast Cancer Treatment Worldwide.
2. PubMed: Cost-effectiveness analysis of palbociclib or ribociclib in the treatment of advanced HR+, HER2- breast cancer.
3. Research Nester: CDK4/6 Inhibitor Drugs Market Size & Share | Growth Forecasts 2036.
4. Valuates Reports: Global Palbociclib Drug Market Research Report 2024.
5. ASCO Publications: Real-World Treatment Patterns and Clinical Outcomes in Patients with HR+, HER2- Breast Cancer Treated with Palbociclib Plus Letrozole or Fulvestrant.

Last updated: 2024-12-16