Last updated: March 10, 2026
What is the Drug Profile?
NDC 61314-0318 corresponds to Ertugliflozin, an SGLT2 inhibitor developed by Merck, approved for combination therapy with other antidiabetic agents to manage type 2 diabetes mellitus. It was approved by the FDA in December 2017.
Market Landscape
Indications and Market Size
Ertugliflozin targets type 2 diabetes, a chronic condition affecting over 37 million Americans, with approximately 90-95% managed through pharmacological intervention. The broader SGLT2 inhibitor class, including drugs like Jardiance and Invokana, recorded global sales exceeding $7 billion in 2022.
Competitive Positioning
Ertugliflozin faces competition from established agents:
-
Jardiance (empagliflozin): Market leader with >40% market share.
-
Invokana (canagliflozin): Second-largest, significant prescriber base.
-
Farxiga (dapagliflozin): Growing presence.
Ertugliflozin's market penetration remains modest due to late entry, clinical perception, and formulary dynamics. Its primary value proposition is comparable efficacy with potential reduced side effects.
Market Share and Usage Data
In 2022, Ertugliflozin accounted for approximately 5-7% of the SGLT2 class sales. Prescriptions averaged around 2 million annually in the U.S., primarily driven by specialist endocrinology and primary care.
Reimbursement and Adoption
Reimbursement policies favor established agents. Key insurers require evidence of comparable efficacy, which limits rapid substitution of competitors. Price discounts and formulary placements influence prescribing patterns.
Price Trends and Projections
Current Pricing
The average wholesale price (AWP) for a 30-day supply of Ertugliflozin (5 mg) is approximately $490. Discounting and net prices vary with pharmacy benefit managers (PBMs), resulting in gross-to-net discounts averaging 20-40%.
12-Month Historical Price Changes
| Year |
AWP for 30-day supply |
Gross-to-Net Discount |
Net Price (Approximate) |
| 2020 |
$480 |
30% |
~$336 |
| 2021 |
$485 |
35% |
~$316 |
| 2022 |
$490 |
40% |
~$294 |
Future Price Dynamics
Factors influencing pricing:
- Market penetration: As volume increases, economies of scale may reduce net prices further.
- Generic entry: No generic Ertugliflozin expected within the next 3-5 years due to patent protections and exclusivities.
- Reimbursement policies: Payers may negotiate discounts to favor established drugs, keeping prices stable.
- Competitive pricing: Price competition from other SGLT2 inhibitors may lead to price erosion if Ertugliflozin gains market share.
Price Projections (Next 2-5 Years)
| Year |
Expected AWP for 30-day supply |
Net Price Range |
Comments |
| 2023 |
$495 - $510 |
~$290 - $350 |
Slight increase due to inflation and demand |
| 2024 |
$500 - $520 |
~$280 - $340 |
Potential stabilization; increased volume |
| 2025 |
$510 - $530 |
~$275 - $330 |
Market saturation may limit price growth |
Prices likely to stabilize unless significant shifts occur in market dynamics or patent challenges.
Critical Market Drivers
- Regulatory approvals: Expansion into other indications, such as chronic kidney disease, may expand the market.
- Formulary inclusion: Favorable placement boosts usage.
- Clinician and patient perception: Efficacy and safety profile influence prescribing.
Risks and Opportunities
Risks:
- Slow adoption compared to established agents.
- Price competition potentially forcing discounts.
- Patent expiry not imminent but boosting generic threats risk long-term erosion.
Opportunities:
- Expansion into new indications.
- Differentiation through formulation and delivery.
- Developing combination therapies to improve adherence and outcomes.
Key Takeaways
- NDC 61314-0318 (Ertugliflozin) is a late entrant in a mature class with limited market share but stable sales.
- Current AWP stands around $490 for a 30-day supply with net prices near $290-$350.
- Market share is expected to grow modestly over the next five years, driven by increased prescribing, especially if approved for additional indications.
- Price stability is likely in the short term, with potential for slight erosion due to increased volume and competitive pressures.
FAQs
Q1: Will Ertugliflozin's price decline as it approaches patent expiry?
A1: Yes, generic entry typically causes significant price reductions within 2-3 years of patent expiration.
Q2: How does Ertugliflozin compare price-wise to other SGLT2 inhibitors?
A2: Its current AWPs are similar or slightly higher than competitors, but net prices depend on negotiated discounts.
Q3: What factors could drive up Ertugliflozin's price?
A3: Approved expanded indications and increased formulary acceptance can support price stability or growth.
Q4: How much market share can Ertugliflozin realistically expect in the next five years?
A4: Potential to reach 10-15% of the SGLT2 market if adoption barriers decrease.
Q5: Are there imminent patent challenges or exclusivity periods for Ertugliflozin?
A5: No significant patent challenges are public as of 2023; patent protections extend into the mid-2020s.
References
- FDA. (2017). Ertugliflozin drug approval information.
- IQVIA. (2022). Prescription drug sales data.
- GoodRx. (2022). Price comparison for SGLT2 inhibitors.
- U.S. Patent and Trademark Office. (2023). Patent status for Ertugliflozin.
- MarketWatch. (2022). Diabetes drug market analysis.
