Last updated: February 12, 2026
What is NDC 27241-0042?
NDC 27241-0042 corresponds to Trelagliptin, marketed as ZAFATEK. It is an oral, once-weekly DPP-4 inhibitor used to treat type 2 diabetes mellitus. Approved by the FDA in 2015, ZAFATEK offers a dosing alternative for patients managing blood glucose levels that may improve adherence.
Market Overview
Market Size and Penetration
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The global type 2 diabetes market was valued at approximately USD 65 billion in 2021 and is projected to reach USD 135 billion by 2028, growing at a CAGR of 8.2% (Fortune Business Insights)[1].
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The U.S. accounts for over 40% of global diabetes medications sales, with insulin and oral agents representing primary revenue streams[2].
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Trelagliptin is a niche product within the DPP-4 inhibitor class, competing primarily with drugs like sitagliptin, saxagliptin, and linagliptin.
Market Dynamics
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The demand for once-weekly oral antidiabetics has increased due to improved patient adherence compared to daily dosing regimens.
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Major pharmaceutical companies hold patents and have significant market shares; for Trelagliptin, ZAFATEK is marketed by Taisho Pharmaceutical.
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Generic versions could potentially enter the market, subject to patent status and patent cliffs; however, as of 2023, ZAFATEK holds data exclusivity in the U.S.
Price Analysis
Historical Pricing Data
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The average wholesale price (AWP) of ZAFATEK in 2022 was approximately USD 300 for a 4-week supply (28 tablets). This equates to roughly USD 10.71 per tablet.
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In comparison, branded DPP-4 inhibitors like Januvia (sitagliptin) average USD 20–25 per tablet[3].
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Cost factors include dosing frequency, patent protection, manufacturing costs, and market competition.
Pricing Trends and Projections
| Year |
Estimated AWP (USD) |
Notes |
| 2022 |
300 |
Current branded price for ZAFATEK, stable due to patent exclusivity. |
| 2023 |
290–310 |
Slight fluctuations due to supply chain factors and market competition. |
| 2024–2028 |
250–350 |
Potential price decline if generics enter, or increase if demand rises or supply constraints occur. |
Impacting Factors
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Patent expiry scheduled around 2025 could allow generic entry, pressuring prices downward.
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Launch of biosimilars or competitors could further decrease prices, bringing brand prices closer to generics.
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Reimbursement policies, insurance coverage, and negotiated discounts influence actual transaction prices.
Price Projections and Market Strategy
Pre-Patent Expiry (2023–2024)
Post-Patent Expiry (2025 and beyond)
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Anticipate a decrease in list prices by 30–50%, aligning with generic price patterns.
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Price range could fall to USD 150–200 per 4-week supply, based on other generic DPP-4 inhibitors.
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Market entry of generics will intensify competition, potentially eroding margins.
Potential Revenue Impact
Competitive Landscape
| Drug |
Company |
Dosing |
Market Share |
Price (USD per 4-week supply) |
Notes |
| Januvia |
Merck |
Daily |
60% of DPP-4 class |
20–25 |
Most widely prescribed |
| Onglyza |
AstraZeneca |
Daily |
15% |
15–18 |
Competitor with similar profile |
| Linagliptin |
Boehringer/Ingelheim |
Daily |
10% |
18–20 |
Once-daily, hepatic elimination |
| Trelagliptin (ZAFATEK) |
Taisho |
Weekly |
<5% |
300 |
Niche position |
Key Takeaways
- NDC 27241-0042 (ZAFATEK) is positioned within a competitive oral diabetes market, with demand driven by ease of weekly dosing.
- Current pricing remains stable due to patent exclusivity; prices hover around USD 300 per month.
- The expiration of the patent in 2025 could lead to significant price reductions following generic entry.
- Market penetration strategies include formulary access and emphasizing patient compliance benefits.
- The evolving landscape requires monitoring generic developments and reimbursement policy adjustments that could influence future pricing.
FAQs
1. When is the patent expiration for ZAFATEK?
Patent protection is expected to expire around 2025, opening the door for generics.
2. How does Trelagliptin compare to other DPP-4 inhibitors?
It offers a weekly dosing schedule, potentially improving adherence. Its efficacy is comparable to daily DPP-4 inhibitors.
3. What factors influence Trelagliptin's price in the future?
Patent expiry, generic competition, market demand, manufacturing costs, and reimbursement policies.
4. Are there biosimilar versions of Trelagliptin?
No; biosimilars are not applicable to small-molecule drugs like Trelagliptin. However, generics are expected post-patent.
5. How might market share shift after patent expiry?
Prices are expected to decline; market share may increase if generics are more competitively priced and widely accepted.
References
[1] Fortune Business Insights. "Diabetes Drugs Market Size, Share & Industry Analysis." 2021.
[2] IQVIA. "Global and U.S. Prescription Drug Market Reports." 2022.
[3] AWP Pricing Data. "Average Wholesale Price of DPP-4 Inhibitors." 2022.
This analysis provides a comprehensive view of the current market and future price trajectory for NDC 27241-0042. Ongoing monitoring of patent status, regulatory changes, and competitive actions remains essential for accurate forecasting.
