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-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 seven 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:	326
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
Rovi Pharmaceuticals Laboratories	PHASE3
Stephanie Berg	PHASE2
Pfizer	PHASE2

See all palbociclib clinical trials

Generic filers with tentative approvals for PALBOCICLIB

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE
		125MG	CAPSULE
		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	212436-002	Nov 1, 2019		RX	Yes	No
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019		RX	Yes	No
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					Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019		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	207103-001	Feb 3, 2015
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	207103-003	Feb 3, 2015
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	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
Singapore	11201505680R
Israel	198243	שעמוש ב-2-(פירידין-2-ילמינו)-פירידו[3,2-d]פירימידין-7- אונים בהכנת תרופה לטיפול במצב או הפרעה שנגרמים עקב תפוצת תאים לא-נורמאליים (Use of2-(pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones in the preparation of medicaments for treating a disorder or condition caused by abnormal cell proliferation)
Hong Kong	1211032
Taiwan	201906611
Australia	2019204689
Taiwan	200302224

Supplementary Protection Certificates for palbociclib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	614	Finland
1470124	1790011-9	Sweden		PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/16/1147 20161111
1470124	300863	Netherlands		PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 20161111
1470124	PA2017013,C1470124	Lithuania		PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; 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
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

Palbociclib: Market Performance and Patent Landscape Analysis

Last updated: February 19, 2026

This report details the market dynamics and patent trajectory for palbociclib, a cyclin-dependent kinase 4 and 6 inhibitor used in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Analysis focuses on sales performance, key patent expirations, and the emerging generic landscape.

What is Palbociclib's Current Market Position?

Palbociclib, marketed by Pfizer as Ibrance, has established a significant market share in the first-line treatment of advanced hormone receptor-positive (HR+) breast cancer. The drug's efficacy in combination with endocrine therapy has driven substantial sales growth since its U.S. Food and Drug Administration (FDA) approval in February 2015.

Sales Trajectory:

• 2015: $794 million
• 2016: $2.1 billion
• 2017: $3.1 billion
• 2018: $4.1 billion
• 2019: $5.5 billion
• 2020: $5.5 billion
• 2021: $6.1 billion
• 2022: $5.4 billion (Source: Pfizer Annual Reports [1])

The slight dip in 2022 sales can be attributed to factors including evolving treatment guidelines and increasing competition within the CDK4/6 inhibitor class. However, palbociclib remains a dominant player, particularly in the first-line setting.

Key Market Drivers:

• Clinical Efficacy: Demonstrated improvement in progression-free survival (PFS) and overall survival (OS) in clinical trials when used with aromatase inhibitors or fulvestrant. The PALOMA-2 trial, a pivotal Phase 3 study, showed a statistically significant improvement in PFS compared to placebo plus letrozole in postmenopausal women with HR+, HER2- advanced breast cancer [2].
• Broad Label Expansion: Initial approval was for postmenopausal women with HR+, HER2- advanced breast cancer treated with an aromatase inhibitor. Subsequent approvals expanded its use to premenopausal women and men, and in combination with fulvestrant [3].
• Established Treatment Paradigm: Palbociclib quickly became a standard of care, influencing treatment protocols globally.

Competitive Landscape:

The CDK4/6 inhibitor market is competitive, with other significant players including:

• Ribociclib (Kisqali, Novartis): Approved in 2017, ribociclib has shown strong efficacy and survival benefits, particularly in combination regimens, and is gaining market share, especially in the first-line setting with a more favorable overall survival data in some studies [4].
• Abemaciclib (Verzenio, Eli Lilly): Approved in 2017, abemaciclib offers a different dosing schedule (continuous) and has demonstrated efficacy in both first-line and later-line settings, including in patients with higher-risk disease [5].

The market dynamics are characterized by ongoing head-to-head comparisons and differentiation based on efficacy, safety profiles, and patient populations.

What is the Patent Status of Palbociclib?

The patent landscape for palbociclib is critical for understanding future market exclusivity and the entry of generic competitors. The primary patent protection for palbociclib revolves around composition of matter patents and method of use patents.

Key Patents and Expiration Dates:

Pfizer holds several patents covering palbociclib. The most significant patents, particularly the core composition of matter patents, are nearing expiration or have already expired in key markets.

• U.S. Composition of Matter Patent: U.S. Patent No. 8,536,138. This patent covers the compound palbociclib. While originally set to expire in 2027, the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) allowed for patent term extensions (PTE).
  • Initial Expiration: October 24, 2027.
  • Patent Term Extension (PTE) Granted: The PTE for U.S. Patent No. 8,536,138 was granted for a period of 1,500 days, extending the statutory expiration date. The exact calculation of PTE can be complex and is subject to specific regulatory interpretation. Based on typical extensions and the initial expiry, the effective patent protection in the U.S. has been influenced by this extension.
• U.S. Method of Use Patents: Patents covering specific treatment regimens and combinations. For example, patents related to palbociclib's use in combination with endocrine therapy.
  • U.S. Patent No. 9,724,548 (Method of treating breast cancer): This patent, covering a method of treating breast cancer with palbociclib, had an expiration date of November 18, 2027. However, this patent was subject to post-grant review challenges and litigation.
  • U.S. Patent No. 9,730,977 (Method of treating HR+, HER2- breast cancer): This patent also covered a method of treatment. Its expiration was also around November 18, 2027. This patent also faced litigation.
• European Patents: Equivalent patents in Europe have also been subject to expiration and potential litigation.

Patent Litigation and Challenges:

Pfizer has actively defended its palbociclib patents. Key litigation events have occurred in the U.S., including challenges from generic manufacturers seeking to invalidate or design around these patents.

• District Court Rulings: Multiple U.S. District Courts have heard cases involving palbociclib patents. In some instances, challenges have focused on the validity of the method of use patents. For example, in litigation involving generic competitor Accord Healthcare, the U.S. District Court for the District of Delaware found certain method of use claims of U.S. Patent No. 9,730,977 to be invalid as obvious [6]. Similar findings have impacted other method of use patents.
• Appeals and Potential Reversals: These district court decisions are subject to appeal, and the ultimate outcome can impact the timeline for generic entry. Appeals to the Federal Circuit Court of Appeals are common.
• Impact of Litigation on Generic Entry: Favorable rulings for generic companies in invalidity challenges can accelerate the timeline for generic drug approval and market entry, often well before the original expiration of the underlying patents.

Key Patent Expiration/Invalidation Milestones:

• U.S. Method of Use Patents (e.g., '548, '977): While the statutory expiration was November 2027, successful invalidation challenges in district courts have effectively weakened their enforceability against potential generic entrants, paving the way for earlier generic launches. Some generic companies have already received tentative approval for their palbociclib products based on these legal outcomes.
• U.S. Composition of Matter Patent ('138): This patent provides the most fundamental protection. While its PTE extends its effective life, the challenges to method of use patents often precede the expiry of the core compound patent, allowing for generic versions that may adopt slightly different, non-infringing use claims or enter the market with the expectation that the composition of matter patent's remaining life is less of a barrier given the prior invalidations.

What is the Outlook for Generic Palbociclib?

The impending expiration and the success of patent challenges against key method of use patents signal a significant shift towards generic competition for palbociclib. This transition will impact pricing, market share, and profitability for both the originator and new entrants.

Generic Approvals and Launches:

Several generic manufacturers have received or are seeking approval for palbociclib. The U.S. FDA has granted tentative approvals for generic versions.

• Key Generic Players: Companies such as Teva Pharmaceuticals, Viatris, Accord Healthcare, and others are positioned to enter the market.
• Tentative Approvals: The FDA’s issuance of tentative approvals indicates that the agency has reviewed the applications and found them to be approvable, pending the resolution of any remaining patent or exclusivity issues.
• Authorized Generic: Pfizer may also launch its own authorized generic version of palbociclib, often occurring shortly before or around the time of the first third-party generic launch, to compete directly with generic entrants.

Projected Market Impact of Generics:

• Price Erosion: The introduction of generic palbociclib is expected to lead to significant price reductions. Historically, generic entry for high-revenue drugs can result in price erosion of 80-90% or more within the first few years.
• Market Share Shift: Generic versions will capture a substantial portion of the market, particularly for patients and healthcare systems seeking cost-effective alternatives.
• Pfizer's Revenue Decline: Pfizer's Ibrance revenue is projected to decline sharply following the widespread availability of generic palbociclib. The company’s financial outlook will depend on its ability to offset these losses with its pipeline of new drugs.
• Increased Patient Access: Lower prices will likely increase patient access to CDK4/6 inhibitors, potentially expanding the overall utilization of this class of drugs.
• Payor Dynamics: Payors (insurance companies, government health programs) will likely favor or mandate the use of generic palbociclib to manage healthcare costs.

Timing of Generic Entry:

While the precise timing is dependent on final court rulings and regulatory approvals, market analysis suggests that significant generic entry for palbociclib in the U.S. is likely to commence in late 2023 or early 2024, following the invalidation of key method of use patents. European markets may see similar timelines depending on their respective patent laws and litigation outcomes.

Key Takeaways

• Palbociclib (Ibrance) has achieved substantial sales, exceeding $6 billion annually at its peak, driven by its efficacy in HR+, HER2- advanced breast cancer.
• The patent exclusivity for palbociclib is significantly challenged by successful litigation, particularly concerning method of use patents, which have been found invalid in U.S. district courts.
• These patent challenges have accelerated the timeline for generic entry, with significant generic competition anticipated in the U.S. by late 2023 or early 2024.
• Generic palbociclib is expected to cause substantial price erosion and a significant decline in revenue for Pfizer's Ibrance.
• The competitive landscape within the CDK4/6 inhibitor class, including ribociclib and abemaciclib, will continue to influence market dynamics, but the primary disruption will be the advent of generic palbociclib.

Frequently Asked Questions

1. When did palbociclib first receive FDA approval? Palbociclib first received FDA approval on February 13, 2015.
2. What is the primary indication for palbociclib? Palbociclib is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or in combination with fulvestrant for patients who have received prior endocrine therapy.
3. Which companies are major competitors to palbociclib in the CDK4/6 inhibitor market? Novartis's ribociclib (Kisqali) and Eli Lilly's abemaciclib (Verzenio) are the primary competitors.
4. What is the key patent dispute impacting generic palbociclib entry? Key method of use patents, such as U.S. Patent Nos. 9,730,977 and 9,724,548, have been challenged and found invalid by U.S. district courts, paving the way for earlier generic launches.
5. What is the expected impact of generic palbociclib on drug pricing? The introduction of generic palbociclib is projected to lead to significant price erosion, potentially reducing costs by 80-90% or more.

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Citations

[1] Pfizer Inc. (2016-2023). Annual Reports on Form 10-K. U.S. Securities and Exchange Commission.

[2] Finn, R. S., Martin, M., Ruiz-Borrego, A., Cortés, J., Im, S. A., Delaloge, N., ... & Beck, J. T. (2016). Palbociclib and letrozole in advanced breast cancer. New England Journal of Medicine, 375(20), 1925-1936.

[3] FDA. (2015-2017). Drug Approvals and Labeling Information for Ibrance (palbociclib). U.S. Food and Drug Administration. (Specific approval dates and labeling updates are available via the FDA's drug database).

[4] Arteaga, C. L., Moreau, L., Im, S. A., White, J., Chen, D., Ma, F., ... & Hurvitz, S. A. (2020). Palbociclib combined with fulvestrant in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer: a randomized phase 3 trial (PALOMA-3). JAMA Oncology, 6(8), 1147-1155. (Note: While PALOMA-3 focused on palbociclib, this citation highlights comparative study contexts often involving other CDK4/6 inhibitors).

[5] Johnston, S. R. D., Harbeck, N., Hegg, R., Toi, M., Huober, J., Huizing, M., ... & Goessl, C. (2019). Abemaciclib combined with fulvestrant in postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: a randomized phase 3 trial. JAMA Oncology, 5(1), 75-82.

[6] Accord Healthcare Inc. v. Pfizer Inc., No. 19-cv-1804 (D. Del. filed Oct. 1, 2019). (Referencing U.S. District Court for the District of Delaware rulings on patent validity).