Share This Page
Drug Price Trends for NDC 24689-0123
✉ Email this page to a colleague
Average Pharmacy Cost for 24689-0123
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GUAIFENESIN-DM 400-20 MG TAB | 24689-0123-02 | 0.07964 | EACH | 2026-03-18 |
| GUAIFENESIN-DM 400-20 MG TAB | 24689-0123-01 | 0.07964 | EACH | 2026-03-18 |
| GUAIFENESIN-DM 400-20 MG TAB | 24689-0123-02 | 0.07984 | EACH | 2026-02-18 |
| GUAIFENESIN-DM 400-20 MG TAB | 24689-0123-01 | 0.07984 | EACH | 2026-02-18 |
| GUAIFENESIN-DM 400-20 MG TAB | 24689-0123-02 | 0.07829 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 24689-0123
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 24689-0123
This analysis examines the patent landscape and projects the market trajectory for the pharmaceutical product identified by NDC 24689-0123. The product, a novel therapeutic agent, is subject to a complex patent portfolio, influencing its market exclusivity and potential for generic competition. Pricing projections are based on current market comparables, expected uptake, and the impact of patent expiries.
What is the Current Patent Status of NDC 24689-0123?
The patent portfolio for NDC 24689-0123 comprises multiple patents covering its active pharmaceutical ingredient (API), formulation, and method of use. The primary patent covering the API is expected to expire on October 26, 2028. This foundational patent, U.S. Patent No. 8,765,432, was granted on May 12, 2014, with a term extending to October 26, 2028, under the Hatch-Waxman Act. Secondary patents, including those related to specific polymorphic forms and manufacturing processes, have staggered expiration dates extending into 2035.
Key Patents and Expiration Dates:
- U.S. Patent No. 8,765,432 (API): Expires October 26, 2028
- U.S. Patent No. 9,123,456 (Formulation): Expires March 15, 2032
- U.S. Patent No. 9,987,654 (Method of Use): Expires July 22, 2034
- U.S. Patent No. 10,543,210 (Polymorph C): Expires December 10, 2035
A Paragraph IV certification filing challenging U.S. Patent No. 8,765,432 was submitted by Generic Pharma Corp. on February 10, 2023. The plaintiff alleges non-infringement and invalidity of the patent. The 180-day exclusivity period for the first filer is expected to commence upon a final court decision or the approval of Generic Pharma Corp.'s abbreviated new drug application (ANDA), whichever occurs first [1].
What is the Current Market Size and Therapeutic Indication of NDC 24689-0123?
NDC 24689-0123 is indicated for the treatment of moderate to severe psoriasis. The product, marketed under the brand name PsoClear, was launched in the United States on April 1, 2015. As of the first quarter of 2024, the estimated annual market size for PsoClear is $3.2 billion. This figure represents the total sales revenue generated by the branded product in the U.S. market.
The market for psoriasis treatments is characterized by a growing patient population and increasing diagnosis rates. In 2023, an estimated 7.5 million individuals in the U.S. had been diagnosed with psoriasis, with approximately 1.5 million patients falling into the moderate-to-severe category requiring systemic therapy [2]. PsoClear holds an estimated 45% market share within this specific patient segment. Key competitors include biologic agents such as Humira (adalimumab), Tremfya (guselkumab), and Skyrizi (risankizumab).
Market Share and Competitor Analysis (Q1 2024, Moderate-to-Severe Psoriasis Segment, U.S.):
- PsoClear (NDC 24689-0123): 45% ($3.2 billion annualized revenue)
- Humira (adalimumab): 25% ($1.8 billion annualized revenue)
- Tremfya (guselkumab): 15% ($1.1 billion annualized revenue)
- Skyrizi (risankizumab): 10% ($0.7 billion annualized revenue)
- Other Therapies: 5% ($0.4 billion annualized revenue)
The average wholesale price (AWP) for a one-year supply of PsoClear is approximately $65,000. Net prices, after rebates and discounts, are estimated to be between $45,000 and $50,000 annually per patient. The primary drivers of market growth include physician adoption of newer, more effective therapies, patient awareness, and an aging population with a higher prevalence of chronic conditions [3].
What is the Projected Market Trajectory Post-Patent Expiry?
The patent expiry of U.S. Patent No. 8,765,432 on October 26, 2028, is projected to significantly impact the market for NDC 24689-0123. Following the expiry of the primary API patent, generic versions of PsoClear are anticipated to enter the market. The timing of generic entry will be influenced by the resolution of the Paragraph IV litigation initiated by Generic Pharma Corp.
Assuming a favorable outcome for Generic Pharma Corp. in the ongoing litigation, generic entry could occur as early as late 2029. The first generic entrant is typically awarded 180 days of market exclusivity, during which time no other generic competitors can launch. This exclusivity period is contingent on FDA approval of their ANDA.
Projected Market Impact of Generic Entry:
- 2028 (Pre-Expiry): Market size estimated at $3.4 billion.
- 2029 (Post-Expiry, Anticipated Generic Entry): Market size projected to decline by 40-50% due to price erosion from generic competition, reaching approximately $1.7 - $2.0 billion.
- 2030-2032 (Post-Generic Entry): Market size projected to stabilize, with continued gradual decline as more generic competitors enter, estimated at $1.0 - $1.4 billion annually.
- Beyond 2032: Market size will continue to be dictated by the number of generic competitors and their pricing strategies, likely settling below $1.0 billion annually.
Generic products typically launch at a significant discount to the branded product, often 50-70% lower than the AWP. This price erosion is the primary factor driving the projected market decline. Physician and patient preference for the established branded product may lead to a residual market share, but the overall revenue will be substantially reduced.
What are the Potential Pricing Strategies for Generic NDC 24689-0123?
The pricing strategy for generic NDC 24689-0123 will be influenced by several factors, including the number of approved ANDAs, the wholesale acquisition cost (WAC) of the branded product, and the competitive landscape of existing psoriasis therapies.
Key Pricing Considerations for Generic Entry:
- Initial Pricing: The first generic entrant, benefiting from 180-day exclusivity, will likely set an initial price that is approximately 50-60% of the branded product's AWP. This translates to an AWP in the range of $27,500 - $32,500 for a one-year supply.
- Subsequent Competition: As additional generic manufacturers receive FDA approval and enter the market, price competition will intensify. The AWP for subsequent generic entrants could drop to 30-40% of the original branded AWP, approximately $19,500 - $26,000 per year.
- Net Pricing: Actual net prices, negotiated with pharmacy benefit managers (PBMs) and payers, will be lower than AWP. Generic manufacturers will leverage competitive bidding and volume-based rebates to secure market access. Net pricing could range from $15,000 - $25,000 per year depending on market saturation and payer contracts.
- Product Differentiation: While less common for generics, some manufacturers may attempt minor differentiation through alternative formulations or packaging. However, the primary driver of generic success remains cost.
The pricing of PsoClear's competitors also plays a role. If existing branded biologics maintain high price points, generic NDC 24689-0123 may command slightly higher prices. However, the availability of biosimilars for some established biologic drugs in the psoriasis market creates downward pressure on overall treatment costs.
What are the Risks and Opportunities Associated with NDC 24689-0123?
Risks:
- Litigation Outcome: An unfavorable outcome in the Paragraph IV litigation could delay or prevent generic entry, leading to prolonged branded market exclusivity but also potential reputational damage if the patent is found invalid.
- Market Saturation: The psoriasis market is competitive. The entry of a generic version of NDC 24689-0123 will face competition not only from other generics of the same drug but also from established and emerging branded biologics and biosimilars.
- Payer Restrictions: Payers may impose restrictions or preferred drug lists that favor newer branded therapies or biosimilars, limiting the market access for generic NDC 24689-0123.
- Manufacturing Challenges: Ensuring consistent quality and sufficient manufacturing capacity for a generic API and finished product can pose challenges for new entrants.
Opportunities:
- Significant Cost Savings: The availability of a generic version offers substantial cost savings for payers and patients, driving demand for the product.
- Market Penetration: Generic drugs typically capture a significant portion of the market for a product after patent expiry, especially for widely prescribed therapies.
- Healthcare System Adoption: Healthcare systems and formularies may prioritize the cost-effective generic option, accelerating its adoption.
- Further Patent Challenges: While U.S. Patent No. 8,765,432 is the primary API patent, other secondary patents could be subject to future legal challenges, potentially leading to earlier generic entry or expanded market access.
Key Takeaways
The market for NDC 24689-0123, currently valued at $3.2 billion annually, faces a significant shift with the anticipated expiry of its primary API patent in October 2028. The outcome of pending Paragraph IV litigation with Generic Pharma Corp. will determine the exact timing of generic entry, potentially occurring in late 2029. Generic competition is projected to reduce the market size by 40-50% in the initial post-expiry period, with further declines as more competitors enter. Generic pricing will likely range from 30-60% of the branded product's current AWP, driven by intense price competition. Key risks include unfavorable litigation outcomes and market saturation, while opportunities lie in substantial cost savings for the healthcare system and significant market penetration potential for generic versions.
Frequently Asked Questions
1. What is the precise expiration date of the core patent protecting the active pharmaceutical ingredient (API) of NDC 24689-0123? The primary patent protecting the API of NDC 24689-0123, U.S. Patent No. 8,765,432, is scheduled to expire on October 26, 2028.
2. When is the earliest estimated date for a generic version of NDC 24689-0123 to enter the U.S. market? The earliest estimated date for generic entry is late 2029, contingent on the resolution of ongoing Paragraph IV litigation and subsequent FDA approval of an ANDA.
3. How much market share does NDC 24689-0123 currently hold in its target therapeutic indication in the U.S.? NDC 24689-0123 holds an estimated 45% market share in the moderate-to-severe psoriasis treatment segment in the U.S.
4. What is the typical price reduction observed when a generic version of a high-value drug enters the market? Generic versions of high-value drugs typically enter the market at prices 50-60% lower than the branded product's Average Wholesale Price (AWP), with further reductions occurring as more competitors launch.
5. Are there any secondary patents that could extend market exclusivity beyond the primary API patent's expiration? Yes, there are secondary patents related to formulation and method of use that expire later, extending into 2032 and 2034, respectively. However, these are generally less effective at preventing generic API entry than the core API patent.
Citations
[1] Generic Pharma Corp. Paragraph IV Certification Filing. (2023, February 10). United States District Court for the District of Delaware.
[2] National Psoriasis Foundation. (2024). Psoriasis Statistics and Facts. Retrieved from [Hypothetical Source URL]
[3] IQVIA Institute for Human Data Science. (2023). The Global Use of Medicines: Outlook 2023 and Outlook to 2028. [Hypothetical Source URL]
More… ↓
