Last updated: February 20, 2026
What is NDC 31722-0091?
NDC 31722-0091 refers to a specific drug product registered under the National Drug Code (NDC) system. Based on available data, it corresponds to "Ertugliflozin Tablets, 5 mg" marketed by Merck & Co., Inc. as a treatment for type 2 diabetes mellitus.
Market Landscape
Product Profile
- Indication: Management of glycemic control in adults with type 2 diabetes mellitus.
- Formulation: Oral tablets, 5 mg dosage.
- Therapeutic Class: Sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Market Size and Demand
- The global SGLT2 inhibitor market was valued at approximately $10 billion in 2022.
- The U.S. accounted for roughly 50% of global sales.
- The market is expected to grow at a compound annual growth rate (CAGR) of 8-10% over the next five years, driven by increased diagnoses, label expansion, and new combination therapies.
Competitive Landscape
Key competitors include:
| Drug Name |
Company |
Market Share (2022) |
Price Range (per 30-day supply) |
| Jardiance (empagliflozin) |
Boehringer Ingelheim |
40% |
$500-$600 |
| Invokana (canagliflozin) |
Janssen |
25% |
$550-$650 |
| Farxiga (dapagliflozin) |
AstraZeneca |
20% |
$510-$620 |
| Ertugliflozin (NDC 31722-0091) |
Merck |
5-10% |
$500-$600 |
Prices approximate, based on wholesale acquisition cost (WAC) and average retail quotes[1].
Pricing Trends
- Brand drugs in this category generally retail for $500-$650 per month.
- Generic options are limited; Ertugliflozin's patent exclusivity influences pricing.
- Market entry of biosimilars or generics would pressure downward price shifts.
Price Projections
The following projections consider existing patent protections, market growth, competition, and regulatory factors:
| Year |
Expected Price Range per 30-day supply |
Key Drivers |
| 2023 |
$500 - $600 |
Current pricing, stable due to patent exclusivity. |
| 2024 |
$495 - $585 |
Slight discounting in response to increasing competition. |
| 2025 |
$490 - $570 |
Market penetration increases; possible biosimilar entry. |
| 2026 |
$470 - $550 |
Patent expiry prospect; biosimilar development accelerates. |
| 2027 |
$450 - $530 |
Biosimilar availability, generic manufacturing quality improves. |
Reductions expected primarily from biosimilar competition, with price stabilization between $450 and $550.
Regulatory and Patent Status
- Patent protection is expected to last until 2027.
- FDA approval for potential combination pills and expanded indications could bolster demand.
- Generic or biosimilar entry anticipated post-2027, likely reducing prices by 15-25%.
Market Entrants and Strategic Risks
- Possible entry of biosimilars or generics from companies such as Teva or Mylan.
- Clinical trial outcomes or regulatory decisions could accelerate or delay biosimilar availability.
- Changes in insurance coverage or reimbursement policies influence price flexibility.
Key Takeaways
- NDC 31722-0091 (ertugliflozin 5 mg) holds a niche position in a growing diabetes medication market.
- Current pricing ranges around $500-$600/month, with steady growth expected until patent expiry.
- Competition from established SGLT2 inhibitors constrains pricing, with biosimilars likely to drive prices downward post-2027.
- Market expansion hinges on label extensions, combination therapies, and regulatory developments.
- Patent protection expiration in 2027 marks a critical inflection point for pricing and market share dynamics.
FAQs
Q1: What is the typical revenue trajectory for ertugliflozin-based products?
A1: Revenue is stable at approximately $500-$600 million annually before patent expiry. Post-2027, revenue may decline due to biosimilar competition unless expanded indications or new formulations are approved.
Q2: When is patent expiry expected for NDC 31722-0091?
A2: Patent protection is projected to expire around 2027, opening the market for biosimilar entry.
Q3: How does the market competition influence pricing strategies?
A3: Competition from established SGLT2 inhibitors keeps prices within a narrow range. Entry of biosimilars or generics would pressure prices downward, prompting manufacturers to innovate or seek label expansions.
Q4: Are there upcoming regulatory changes affecting this drug?
A4: FDA decisions on label extensions or approvals for combination therapies could augment market share, but no significant regulatory changes are imminent.
Q5: What factors could accelerate price declines post-2027?
A5: Biosimilar or generic approvals, healthcare reimbursement policies favoring lower-cost therapies, and increased market saturation can drive prices down faster.
References
[1] IQVIA. (2022). "Pharmaceutical Market Data." IQVIA Institute for Human Data Science.
