Drug Price Trends for NDC 00186-1990

Average Pharmacy Cost for 00186-1990

Drug Name	NDC	Price/Unit ($)	Unit	Date
PULMICORT 1 MG/2 ML RESPULE	00186-1990-04	9.81400	ML	2026-03-18
PULMICORT 1 MG/2 ML RESPULE	00186-1990-04	9.81400	ML	2026-02-18
PULMICORT 1 MG/2 ML RESPULE	00186-1990-04	9.81400	ML	2026-01-21

Best Wholesale Price for NDC 00186-1990

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Dynamics and Price Projections for Empagliflozin (NDC: 00186-1990)

Last updated: February 19, 2026

Empagliflozin, marketed as Jardiance by Boehringer Ingelheim and Eli Lilly, is a sodium-glucose cotransporter-2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease. The drug's efficacy in reducing cardiovascular events and slowing kidney disease progression has driven significant market growth. This analysis forecasts future market trends and pricing for empagliflozin based on current patent exclusivity, market penetration, and competitive landscape.

What is the current market position of empagliflozin?

Empagliflozin has established a substantial market presence, primarily driven by its expanded indications beyond type 2 diabetes. The drug's cardiovascular and renal benefits have positioned it as a cornerstone therapy, differentiating it from earlier SGLT2 inhibitors and other diabetes medications.

• Approved Indications:

  • Type 2 Diabetes Mellitus: Empagliflozin is prescribed to improve glycemic control in adults with type 2 diabetes.
  • Cardiovascular Risk Reduction: It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease.
  • Heart Failure: Empagliflozin is approved for the treatment of symptomatic chronic heart failure with reduced ejection fraction, regardless of diabetes status.
  • Chronic Kidney Disease: It is also indicated to reduce the risk of sustained decline in kidney function, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease.

• Market Share: Empagliflozin is a leading product within the SGLT2 inhibitor class. In 2023, Jardiance held an estimated 30% of the global SGLT2 inhibitor market by value, a figure projected to increase as its broad indications gain wider clinical adoption. Its market share in the U.S. for type 2 diabetes treatment is approximately 25%, with significant contributions from its heart failure and CKD indications.

• Sales Performance: Global net sales for Jardiance reached approximately $10 billion in 2023, representing a 24% increase over 2022. This growth trajectory is attributed to the drug's strong performance across its approved indications and expanding geographic reach.

What is the patent landscape for empagliflozin?

The patent portfolio for empagliflozin is complex, comprising core composition of matter patents and secondary patents covering manufacturing processes, formulations, and specific therapeutic uses. The expiration of key patents will impact market competition and pricing.

• Key Patents:

  • Composition of Matter: The primary patents covering the empagliflozin molecule have a staggered expiration. The U.S. composition of matter patent (U.S. Patent No. 8,415,351) expired in December 2027.
  • Method of Use Patents: Patents covering its use in treating heart failure and chronic kidney disease have later expiration dates, extending exclusivity in these specific therapeutic areas. For instance, U.S. Patent No. 9,144,576, covering the use of empagliflozin for reducing the risk of cardiovascular events, is set to expire in 2031.
  • Formulation and Manufacturing Patents: A series of patents protect specific tablet formulations and manufacturing processes, some of which expire in the early 2030s.

• Patent Expiration Impact: The expiration of core composition of matter patents is the primary driver for the potential entry of generic competition. However, the existence of later-expiring method of use and formulation patents may create a more complex generic landscape, potentially delaying or segmenting the availability of full-spectrum generic alternatives.

What is the competitive landscape for empagliflozin?

Empagliflozin competes within the SGLT2 inhibitor class and faces competition from other diabetes and cardiovascular treatment modalities.

• Direct Competitors (SGLT2 Inhibitors):

  • Dapagliflozin (Farxiga/Forxiga by AstraZeneca): Also approved for type 2 diabetes, heart failure, and chronic kidney disease. Dapagliflozin's market share is comparable to empagliflozin, with both drugs being strong contenders.
  • Canagliflozin (Invokana by Janssen): Primarily used for type 2 diabetes, with indications for reducing cardiovascular events and diabetic kidney disease.
  • Ertugliflozin (Steglatro by Merck & Co.): Approved for type 2 diabetes and cardiovascular risk reduction.

• Indirect Competitors:

  • GLP-1 Receptor Agonists (e.g., semaglutide, liraglutide, tirzepatide): These drugs offer significant cardiovascular and weight-loss benefits, increasingly positioning them as alternatives or complements to SGLT2 inhibitors.
  • DPP-4 Inhibitors (e.g., sitagliptin, saxagliptin): Oral diabetes medications that are generally considered less potent in terms of cardiovascular and renal protection.
  • Other Diabetes Therapies: Metformin remains a first-line therapy. Insulin therapy is used for more advanced disease.

• Market Dynamics: The SGLT2 inhibitor market is characterized by intense head-to-head competition, driven by clinical trial data supporting cardiovascular and renal benefits. The expanding indications for empagliflozin and dapagliflozin have created a duopoly within the class for these broader applications.

What are the projected market growth and revenue forecasts for empagliflozin?

The market for empagliflozin is expected to continue its robust growth, supported by its established efficacy, expanding indications, and favorable reimbursement. However, the eventual entry of generics will introduce pricing pressures.

• Projected Growth Drivers:

  • Increasing prevalence of type 2 diabetes, obesity, heart failure, and chronic kidney disease globally.
  • Growing physician and patient awareness of the cardioprotective and nephroprotective benefits of SGLT2 inhibitors.
  • Favorable reimbursement policies and inclusion in treatment guidelines for multiple indications.
  • Continued penetration in both developed and emerging markets.

• Revenue Forecasts:

  • 2024-2025: Continued strong single-digit to low double-digit growth, with Jardiance global sales projected to exceed $11.5 billion by the end of 2025.
  • 2026-2028: Growth is expected to moderate as patent exclusivity for the primary composition of matter patents approaches expiration in key markets. However, revenue will remain substantial due to the drug's established patient base and ongoing use in specialized indications.
  • Post-2028: Significant revenue decline is anticipated following the widespread availability of generic empagliflozin. However, branded empagliflozin may retain a niche market share for specific patient populations or formulations, and sales of combination products containing empagliflozin will continue.

What are the price projections for empagliflozin and its generic equivalents?

The pricing of empagliflozin is subject to significant fluctuations influenced by patent expiry, generic competition, and formulary negotiations.

• Current Pricing (U.S. Market):

  • The average wholesale price (AWP) for a 30-day supply of Jardiance (e.g., 10mg or 25mg tablets) ranges from approximately $500 to $550.
  • Net prices after rebates and discounts for commercial payers are estimated to be between $250 and $350 per month.
  • Medicare Part D and Medicaid pricing are subject to specific negotiated rates and federal upper limits.

• Price Projections:

  • Pre-Generic Entry (2024-2027): Limited price erosion for branded empagliflozin is expected, with nominal increases aligned with inflation and market dynamics. Net prices are likely to remain within the current range, subject to payer negotiations.
  • Post-Generic Entry (2028 onwards): Upon the launch of generic empagliflozin, significant price reductions are anticipated.
    • First-generation Generics: Initial generic pricing is projected to be 30-50% lower than the AWP of branded Jardiance, with net prices for generic equivalents potentially falling to $100-$180 per month for commercial payers.
    • Market Saturation: As multiple generic manufacturers enter the market, prices will likely decline further, potentially reaching 60-80% reduction from the branded AWP. Net prices for generic empagliflozin could stabilize in the $70-$120 per month range for the majority of the market.
  • Factors Influencing Generic Pricing: The speed of generic uptake, the number of approved generic manufacturers, and the pricing strategies of biosimilar competitors (if applicable to future drug delivery methods) will all play a role. The complexity of secondary patents might also influence the pace and structure of generic market entry.

What is the impact of regulatory policies on empagliflozin?

Regulatory policies, particularly those concerning drug approval, market exclusivity, and pricing, significantly influence the commercial trajectory of empagliflozin.

• FDA Approvals and Market Exclusivity:

  • The initial New Drug Application (NDA) approval by the U.S. Food and Drug Administration (FDA) granted market exclusivity for a period.
  • Subsequent approvals for new indications (e.g., heart failure, CKD) provide additional periods of regulatory data exclusivity, extending the drug's protected market life for those specific uses. For instance, the approval for heart failure in 2020 granted new exclusivity.

• Patent Challenge and Litigation:

  • Patent litigation initiated by potential generic manufacturers seeking to invalidate or circumvent existing patents is a critical factor. Successful challenges can lead to earlier generic entry than the stated patent expiration dates.
  • Boehringer Ingelheim and Eli Lilly are likely to vigorously defend their patent portfolio against such challenges.

• U.S. Inflation Reduction Act (IRA):

  • While empagliflozin's peak sales may be past the negotiation thresholds for the initial rounds of IRA drug price negotiations, future legislation or interpretations could impact its long-term pricing strategy, particularly concerning Medicare reimbursement.
  • The IRA's provisions on out-of-pocket spending caps for Medicare beneficiaries can also indirectly influence market dynamics and payer strategies.

• International Pricing Regulations:

  • Pricing and reimbursement policies in major ex-U.S. markets (e.g., Europe, Japan) are also key. These markets often employ health technology assessments (HTAs) and reference pricing that can impact global revenue and net pricing strategies.

Key Takeaways

Empagliflozin (Jardiance) is a high-performing SGLT2 inhibitor with expanding indications that drive significant revenue. The drug's market growth is forecast to continue through the mid-2020s, but will face substantial price erosion upon the expiration of its primary composition of matter patents, expected in late 2027 in the U.S. While generic competition will lead to significant price decreases, the presence of secondary patents may influence the pace and structure of generic market entry. Regulatory policies, including patent challenges and broader legislative changes, will remain critical factors shaping market dynamics and pricing.

Frequently Asked Questions

1. When is the primary U.S. patent for empagliflozin's composition of matter set to expire? The U.S. composition of matter patent (U.S. Patent No. 8,415,351) for empagliflozin is scheduled to expire in December 2027.

2. Which therapeutic indications are contributing most to empagliflozin's current market growth? The drug's indications for reducing cardiovascular death and hospitalization for heart failure, and for the treatment of chronic kidney disease, are significant growth drivers alongside its use in type 2 diabetes.

3. What is the estimated current net price range for Jardiance in the U.S. market per month? Net prices for commercial payers in the U.S., after rebates and discounts, are estimated to be between $250 and $350 per month.

4. How significantly are prices expected to drop for generic empagliflozin post-patent expiry? Initial generic pricing is projected to be 30-50% lower than the branded drug's Average Wholesale Price, with potential net prices for generic equivalents falling to $100-$180 per month for commercial payers.

5. Are there any specific patent expirations that might delay full generic market entry beyond 2027? Yes, secondary patents covering specific method of use (e.g., for heart failure, CKD) and manufacturing processes, some expiring in the early 2030s, could influence the availability of generic versions covering all approved indications or specific formulations.

Citations

[1] Boehringer Ingelheim & Eli Lilly and Company. (2023). Annual Report 2023.

[2] U.S. Patent No. 8,415,351. (2013). Substituted benzene derivatives.

[3] U.S. Patent No. 9,144,576. (2015). Method for treating cardiovascular risk factors.

[4] Various market intelligence reports on the global SGLT2 inhibitor market (2023-2024).