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Last Updated: December 22, 2024

PALBOCICLIB Drug Patent Profile


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

Palbociclib is a drug marketed by Synthon Pharms Inc and is included in one NDA.

The generic ingredient in PALBOCICLIB 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® Litigation and Generic Entry Outlook for Palbociclib

A generic version of PALBOCICLIB was approved as palbociclib by SYNTHON PHARMS INC on June 5th, 2024.

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Drug patent expirations by year for PALBOCICLIB
Recent Clinical Trials for PALBOCICLIB

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

SponsorPhase
University Medical Center GroningenPhase 4
Mohammed MilhemPhase 1
AstraZenecaPhase 1/Phase 2

See all PALBOCICLIB clinical trials

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
Synthon Pharms Inc PALBOCICLIB palbociclib TABLET;ORAL 215570-001 Jun 5, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Synthon Pharms Inc PALBOCICLIB palbociclib TABLET;ORAL 215570-002 Jun 5, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Synthon Pharms Inc PALBOCICLIB palbociclib TABLET;ORAL 215570-003 Jun 5, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

PALBOCICLIB Market Analysis and Financial Projection Experimental

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.

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