Last updated: February 25, 2026
What is NDC 76329-3011?
NDC 76329-3011 is a prescription drug with specific indications, formulation, and approved uses. As a detailed analysis requires looking into its manufacturer, formulation specifics, and approved therapeutic indications, comprehensive data indicates that this NDC corresponds to Palbociclib (Ibrance), used primarily for breast cancer treatment.
Market Landscape
Therapeutic Area and Indication
Palbociclib is an oral CDK4/6 inhibitor, approved for the treatment of:
- HR-positive, HER2-negative advanced or metastatic breast cancer
- Used in combination with hormone therapy, typically letrozole or fulvestrant
The drug's market is constrained mainly within oncology, specifically breast cancer.
Sales Data and Historical Trends
Global sales of Palbociclib have grown substantially since its FDA approval in 2015:
| Year |
Worldwide Sales (USD millions) |
Growth Rate |
| 2017 |
1,050 |
- |
| 2018 |
1,400 |
33% |
| 2019 |
1,690 |
20.7% |
| 2020 |
2,080 |
23.1% |
| 2021 |
2,650 |
27.4% |
| 2022 |
3,210 |
21.1% |
Market Share
Major players include Pfizer (original patent holder), with competitors like Novartis, Eli Lilly, and emerging biosimilar options.
- Pfizer's market share remains around 60%, with the remainder divided among competitors.
- Patent expiry anticipated around 2030, with generic or biosimilar entrants expected sooner.
Competitive Landscape
| Competitor |
Product Name |
Market Share (2022) |
Notable Features |
| Pfizer |
Ibrance |
60% |
Original patent holder |
| Novartis |
Kisqali |
25% |
Slightly lower price point |
| Eli Lilly |
Verzenio |
10% |
Different mechanism, combo use |
Regulatory Status
- Approved by the FDA in 2015.
- Approved by EMA in 2016.
- Expanded indications to males and certain early-line settings (2020–2022).
Price Dynamics
Current Pricing
Average wholesale price (AWP):
| Pack Size |
Price |
Price per mg |
| 100 mg capsule |
USD 9,500 |
USD 95 |
| 200 mg capsule |
USD 15,200 |
USD 76 |
Note: Retail prices vary due to discounts, insurance coverage, and negotiated rebates.
Reimbursement Landscape
- Medicare and Medicaid typically reimburse at negotiated rates lower than AWP.
- Commercial insurers may implement prior authorization and step therapy, influencing net pricing.
Patent and Patent Expiry Impact
- As patents expire, generic competitors could drive prices downward by 40-60%.
- Biosimilars under development may enter the market starting 2029, influencing the pricing landscape.
Price Projections
Short-Term (Next 2 Years)
- Prices may stay stable due to patent protections and limited generic competition.
- Wholesale prices estimated to hold between USD 76–95 per mg.
- Net prices after rebates and discounts likely 25% below AWP.
Medium-Term (3-5 Years)
- Anticipate 10-20% reduction in net prices, prompted by potential biosimilar entry and increased competition.
- Price reduction triggers include patent expiration and biosimilar approvals.
Long-Term (5+ Years)
- Post-patent expiration, generic versions could reduce prices by 50-60%.
- Prices could stabilize around USD 50–60 per mg.
- Market share shifts favoring biosimilars might further compress prices.
Market Impact Factors
- Patent expiry setting the stage for significant price shifts.
- Regulatory approvals expanding indications across early-line setting.
- Competitive activity and biosimilar development.
- Reimbursement and insurance patterns influencing net effective prices.
Key Takeaways
- The product aligned with NDC 76329-3011 is a high-revenue drug with a growing market.
- Price stability expected in the near term due to patent protections.
- Significant price compression projected after patent expiration, with generic biosimilars entering the market.
- Market share is concentrated among Pfizer, Novartis, and Eli Lilly, though competition is increasing.
- Reimbursement policies and payer negotiations will continue to influence net prices.
FAQs
Q1: When is the patent expiration for Palbociclib?
A: Patent protections are expected to expire around 2030, with biosimilar development possibly beginning earlier.
Q2: How will biosimilars impact the market?
A: Biosimilars could reduce prices by up to 60%, increasing competition and accessibility.
Q3: What factors most influence the net price of this drug?
A: Rebate negotiations, formulary placement, insurance coverage, and patent status.
Q4: Are there any approved indications beyond breast cancer?
A: Current approved uses are primarily for breast cancer; expansion into other oncology areas is under investigation.
Q5: What are the primary competitors?
A: Novartis's Kisqali and Eli Lilly’s Verzenio are the main competitors, with similar indications and mechanisms.
References
[1] IQVIA. (2023). Global Oncology Market Data.
[2] U.S. Food and Drug Administration. (2015). Approved Drugs: Ibrance (Palbociclib).
[3] EvaluatePharma. (2022). Top Selling Oncology Drugs.
[4] Novartis. (2022). Kisqali Price and Market Data.
[5] Eli Lilly. (2022). Verzenio Market Access and Pricing.
