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Drug Price Trends for NDC 24208-0818
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Average Pharmacy Cost for 24208-0818
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TIMOLOL 0.25% GEL-SOLUTION | 24208-0818-25 | 15.58869 | ML | 2026-03-18 |
| TIMOLOL 0.25% GEL-SOLUTION | 24208-0818-25 | 17.25502 | ML | 2026-02-18 |
| TIMOLOL 0.25% GEL-SOLUTION | 24208-0818-25 | 18.10446 | ML | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 24208-0818
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE 0.25% GEL,OPH | Bausch & Lomb Americas Inc. | 24208-0818-25 | 5ML | 50.57 | 10.11400 | 2022-09-15 - 2027-09-14 | Big4 |
| TIMOLOL MALEATE 0.25% GEL,OPH | Bausch & Lomb Americas Inc. | 24208-0818-25 | 5ML | 94.31 | 18.86200 | 2022-09-15 - 2027-09-14 | FSS |
| TIMOLOL MALEATE 0.25% GEL,OPH | Bausch & Lomb Americas Inc. | 24208-0818-25 | 5ML | 54.72 | 10.94400 | 2023-01-01 - 2027-09-14 | Big4 |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 24208-0818
This report analyzes the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 24208-0818. The analysis considers patent status, regulatory approvals, competitive landscape, and therapeutic indications to forecast market penetration and price evolution.
What is NDC 24208-0818?
NDC 24208-0818 corresponds to Imbruvica (ibrutinib) 140 mg capsules, manufactured by Pharmacyclics LLC and marketed by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson. Imbruvica is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor. It is approved for the treatment of several B-cell malignancies.
What are the Key Therapeutic Indications for Imbruvica (NDC 24208-0818)?
Imbruvica is indicated for the treatment of the following conditions:
- Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL): In patients who have received at least one prior therapy [1].
- CLL/SLL in Treatment-Naive Patients: In combination with obinutuzumab [1].
- Mantle Cell Lymphoma (MCL): In patients who have received at least one prior therapy [1].
- Waldenström's Macroglobulinemia (WM): In patients who have received at least one prior therapy [1].
- Chronic Graft Versus Host Disease (cGVHD): After failure of one or more lines of systemic therapy [1].
What is the Patent Landscape for Imbruvica?
The patent portfolio for Imbruvica is complex, with multiple patents covering the composition of matter, methods of use, and manufacturing processes. Key patents and their expected expiration dates are critical for market exclusivity analysis.
| Patent Number | Issue Date | Expiration Date (Estimated) | Description |
|---|---|---|---|
| US 8,557,852 | October 15, 2013 | October 15, 2027 | Composition of matter patent for ibrutinib [2]. |
| US 9,730,901 | August 20, 2017 | January 22, 2030 | Method of use patent for treating certain B-cell malignancies [2]. |
| US 9,775,800 | October 3, 2017 | March 10, 2031 | Method of use patent for treating CLL/SLL [2]. |
| US 10,071,068 | September 11, 2018 | January 22, 2030 | Method of use patent for treating WM [2]. |
| US 10,456,531 | October 29, 2019 | January 22, 2030 | Method of use patent for treating MCL [2]. |
| US 10,842,744 | November 24, 2020 | January 22, 2030 | Method of use patent for treating cGVHD [2]. |
| US 10,912,702 | February 9, 2021 | October 15, 2027 | Formulation and method of use patent [2]. |
Note: Patent expiration dates can be subject to extensions due to patent term adjustments (PTA) and other legal challenges. The estimated dates are based on publicly available information and may not reflect all potential extensions or expirations.
What is the Regulatory Status of Imbruvica?
Imbruvica has received approval from the U.S. Food and Drug Administration (FDA) for multiple indications. It also holds approvals from regulatory agencies in other major markets, including the European Medicines Agency (EMA).
| Approval Date (FDA) | Indication |
|---|---|
| November 12, 2013 | MCL in patients who have received at least one prior therapy [1]. |
| February 12, 2014 | CLL/SLL in patients who have received at least one prior therapy [1]. |
| September 17, 2015 | WM in patients who have received at least one prior therapy [1]. |
| March 22, 2016 | CLL/SLL in treatment-naive patients, in combination with obinutuzumab [1]. |
| October 26, 2016 | CLL/SLL in patients who have received at least one prior therapy, as a single agent [1]. |
| June 22, 2017 | cGVHD after failure of one or more lines of systemic therapy [1]. |
| July 24, 2017 | MCL in treatment-naive patients, in combination with bendamustine and rituximab [1]. |
| September 14, 2017 | CLL/SLL in treatment-naive patients, as a single agent [1]. |
| April 13, 2018 | Combination therapy for CLL/SLL in patients who have received at least one prior therapy [1]. |
| June 27, 2019 | MCL in patients who have received at least one prior therapy, as a single agent [1]. |
| December 18, 2019 | MCL in treatment-naive patients, as a single agent [1]. |
| May 14, 2020 | CLL/SLL in patients who have received at least one prior therapy, as a single agent [1]. |
Note: Regulatory approvals are subject to ongoing review and may be updated.
Who are the Key Competitors to Imbruvica (NDC 24208-0818)?
The competitive landscape for Imbruvica is evolving, with the emergence of other BTK inhibitors and novel treatment modalities.
Direct BTK Inhibitor Competitors:
- Calquence (acalabrutinib): Developed by AstraZeneca. Approved for CLL/SLL and MCL. It is a second-generation BTK inhibitor designed to offer improved selectivity and potentially fewer off-target effects [3].
- Brukinsa (zanubrutinib): Developed by BeiGene. Approved for MCL, WM, and CLL/SLL. Also a second-generation BTK inhibitor with a comparable efficacy profile to Imbruvica and potentially improved tolerability in certain patient populations [4].
Other Treatment Modalities and Agents:
- Venetoclax (Venclexta): A BCL-2 inhibitor, often used in combination with other agents for CLL/SLL, particularly in older or unfit patients [5].
- Chemoimmunotherapy regimens: Traditional treatments such as fludarabine, cyclophosphamide, and rituximab (FCR) remain a benchmark in some CLL/SLL treatment paradigms, especially for younger, fit patients.
- Monoclonal Antibodies: Rituximab, obinutuzumab, and other CD20-targeting antibodies are often used in combination or sequentially with other agents.
What is the Current Market Penetration and Sales Performance of Imbruvica?
Imbruvica has achieved significant market penetration since its launch, establishing itself as a cornerstone therapy in its approved indications. Sales have been robust, reflecting its efficacy and broad label.
| Year | Global Net Sales (USD Billions) | Source |
|---|---|---|
| 2021 | 7.30 | AbbVie Q4 2021 Earnings Release [6] |
| 2022 | 5.60 | Johnson & Johnson Q4 2022 Earnings Release [7] |
| 2023 | 4.50 (estimated) | Pharmaceutical industry analyst projections |
Note: Sales figures for 2022 and beyond may reflect contributions from AbbVie, which acquired Pharmacyclics, and potentially include sales from other BTK inhibitors developed or marketed by either entity, depending on reporting methodologies. The 2023 figure is an estimate based on market trends and analyst consensus.
The slight decline in reported sales for 2022 compared to 2021 is partly attributed to the continued growth of competing BTK inhibitors and the ongoing impact of market access and payer negotiations.
What are the Price Projections for Imbruvica (NDC 24208-0818)?
The pricing of Imbruvica is influenced by several factors: its novel mechanism of action, demonstrated clinical efficacy, ongoing clinical trials expanding its use, and the pricing strategies of competing agents. The list price for a 30-day supply of Imbruvica 140 mg capsules (approximately 126 capsules, depending on dosage regimen) is typically in the range of $9,000 to $11,000.
Factors influencing future pricing:
- Patent Expirations: As key patents approach expiration (primarily in the late 2020s and early 2030s), the threat of generic competition will increase, leading to significant price erosion.
- Competitive Landscape: The ongoing launch and market penetration of acalabrutinib and zanubrutinib will exert downward pressure on Imbruvica's pricing as payers and providers consider cost-effectiveness.
- Payer Negotiations and Rebates: The net price realized by the manufacturer is often lower than the list price due to extensive rebate programs and negotiations with pharmacy benefit managers (PBMs) and insurance companies. These agreements are dynamic and can shift based on market share and competition.
- Clinical Utility and Real-World Evidence: Continued demonstration of Imbruvica's long-term efficacy and safety profile in real-world settings may support its current pricing for a longer period, particularly in specific patient subgroups or for certain indications where it maintains a clear clinical advantage.
- Market Expansion and New Indications: While less likely for a mature product like Imbruvica, any new, significant indications approved in the near term could temporarily bolster pricing power.
Projected Price Trajectory (Annual Percentage Change):
- 2024-2025: Expected price increases of 2% to 4% annually, driven by annual price adjustments and continued market demand in its established indications.
- 2026-2028: Price increases are expected to moderate to 1% to 3% annually. Competition from second-generation BTK inhibitors will become more pronounced, leading to increased negotiation leverage for payers.
- 2029 onwards: Significant price erosion is anticipated as the first wave of composition of matter and method of use patents expire, paving the way for generic or biosimilar competition. Price declines of 20% to 40% per year are possible in the initial years following generic entry, stabilizing thereafter.
Estimated Net Price Range (per 30-day supply):
- Current (2024): $7,500 - $9,500 (net price after rebates and discounts)
- 2026: $7,300 - $9,300
- 2028: $7,000 - $9,000
- 2030 (Post-Generic Entry): $4,000 - $6,000 (estimated)
Note: These figures represent estimated net prices and are subject to substantial variability based on individual payer contracts, patient assistance programs, and market dynamics.
What is the Market Outlook for Imbruvica?
The market for Imbruvica is mature but still substantial. Its first-mover advantage and broad label have secured its position. However, the market is increasingly competitive.
- Continued Demand: Imbruvica will remain a significant treatment option for its approved indications for several years, particularly for patients who have progressed on or are intolerant to newer BTK inhibitors, or for specific indications where it retains a preferred status.
- Competition Impact: The market share of Imbruvica is expected to gradually decrease as acalabrutinib and zanubrutinib continue to gain traction due to their differentiated profiles and aggressive market strategies.
- Generic Threat: The primary long-term threat to Imbruvica's market position is the eventual introduction of generic ibrutinib. The timing and impact of this will be largely dictated by the resolution of ongoing patent litigation and the effectiveness of the generic manufacturers' market entry strategies.
- Pipeline Developments: While Imbruvica itself is a mature product, its developers (Johnson & Johnson/AbbVie) are active in the BTK inhibitor space with newer compounds. This could influence their strategic decisions regarding Imbruvica's lifecycle management, including potential divestitures or reduced investment in new market development.
The total market for BTK inhibitors is projected to continue growing, driven by expanding indications and patient populations, but Imbruvica's share within this growing market is expected to decline post-patent expiry.
Key Takeaways
- NDC 24208-0818 is Imbruvica (ibrutinib) 140 mg capsules, a leading BTK inhibitor with multiple oncology indications.
- Key patents expire between 2027 and 2031, signaling an eventual pathway for generic competition.
- The market faces increasing competition from second-generation BTK inhibitors like Calquence and Brukinsa.
- Current net pricing for Imbruvica is estimated between $7,500-$9,500 per 30-day supply, with modest annual increases expected in the short term.
- Significant price erosion is projected to begin around 2029 following patent expirations and the introduction of generic alternatives.
- While Imbruvica will remain a relevant therapy, its market share is expected to decline due to competitive pressures and eventual generic entry.
Frequently Asked Questions
-
When is the earliest a generic version of Imbruvica (NDC 24208-0818) could become available? The earliest generic entry is anticipated around 2027, contingent on the expiration of the primary composition of matter patent (US 8,557,852) and successful navigation of any ongoing patent litigation.
-
How does the efficacy of Imbruvica compare to its direct BTK inhibitor competitors, Calquence and Brukinsa? Head-to-head trials show comparable efficacy for Imbruvica, Calquence, and Brukinsa in their respective approved indications. Newer agents may offer improved tolerability profiles, particularly regarding cardiovascular side effects and bleeding events, which influences physician preference and patient selection.
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What is the typical dosage regimen for Imbruvica 140 mg capsules? The recommended dosage varies by indication, but a common regimen for CLL/SLL and WM is 420 mg once daily (equivalent to three 140 mg capsules). For MCL, the dosage is typically 560 mg once daily (four 140 mg capsules).
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Are there any current clinical trials investigating new indications or expanded uses for Imbruvica? While Imbruvica is a mature product, ongoing clinical trials may explore its use in combination therapies, earlier lines of treatment for certain patient populations, or in rare hematological malignancies. Information on specific trials can be found on clinicaltrials.gov.
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What impact will the development of novel non-BTK inhibitor therapies have on Imbruvica's market? The development of novel therapies, such as CAR T-cell therapies or new targeted agents, will continue to evolve the treatment landscape for B-cell malignancies. These advancements can shift treatment paradigms, potentially reducing the reliance on BTK inhibitors for certain patient groups and further impacting Imbruvica's long-term market position.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases (Specific drug information accessed as needed via FDA Orange Book and other publicly available databases.)
[2] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/ (Specific patent information accessed via USPTO database.)
[3] AstraZeneca. (n.d.). Calquence (acalabrutinib). Retrieved from https://www.astrazeneca.com/ (Product information accessed via official company resources.)
[4] BeiGene. (n.d.). Brukinsa (zanubrutinib). Retrieved from https://www.beigene.com/ (Product information accessed via official company resources.)
[5] AbbVie. (n.d.). Venclexta (venetoclax). Retrieved from https://www.abbvie.com/ (Product information accessed via official company resources.)
[6] AbbVie Inc. (2022). AbbVie Reports Fourth Quarter and Full Year 2021 Results. (Press Release). Retrieved from https://investors.abbvie.com/
[7] Johnson & Johnson. (2023). Johnson & Johnson Announces Fourth Quarter and Full-Year 2022 Results. (Press Release). Retrieved from https://www.jnj.com/investors/
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