Drug Price Trends for NDC 00713-0575

Average Pharmacy Cost for 00713-0575

Drug Name	NDC	Price/Unit ($)	Unit	Date
METRONIDAZOLE VAGINAL 0.75% GL	00713-0575-71	0.16968	GM	2026-03-18
METRONIDAZOLE VAGINAL 0.75% GL	00713-0575-71	0.18248	GM	2026-02-18
METRONIDAZOLE VAGINAL 0.75% GL	00713-0575-71	0.18465	GM	2026-01-21
METRONIDAZOLE VAGINAL 0.75% GL	00713-0575-71	0.18394	GM	2025-12-17
METRONIDAZOLE VAGINAL 0.75% GL	00713-0575-71	0.17781	GM	2025-11-19

Best Wholesale Price for NDC 00713-0575

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

Nexletol (Bempedoic Acid) Patent Landscape and Market Projections

Last updated: February 18, 2026

Nexletol (bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor approved for reducing low-density lipoprotein cholesterol (LDL-C) in adults. This analysis examines its patent portfolio and projects market performance.

What is the Current Patent Status of Nexletol?

The primary U.S. patent for bempedoic acid, U.S. Patent No. 8,367,687, was granted on February 6, 2013. This patent covers the compound itself and its use in treating hyperlipidemia. Its expiration date is February 6, 2030 [1].

Additional patents have been filed and granted, covering various aspects of the drug's development and use. These include patents related to:

• Formulations: Methods for preparing specific dosage forms of bempedoic acid, enhancing stability and bioavailability. For instance, U.S. Patent No. 10,414,642, granted on September 17, 2019, details a tablet formulation [2].
• Manufacturing Processes: Efficient and scalable methods for synthesizing bempedoic acid.
• Combinations: Patents covering the co-formulation or co-administration of bempedoic acid with other cholesterol-lowering agents, such as statins or ezetimibe. U.S. Patent No. 11,622,805, granted on April 11, 2023, covers combination therapy with ezetimibe [3].
• Methods of Treatment: Patents claiming the use of bempedoic acid for specific patient populations or disease states beyond general hyperlipidemia.

The total number of U.S. patents with claims directly related to bempedoic acid or its direct medical applications is approximately 25. The expiration dates of these secondary patents extend into the early 2030s, with some formulation and method of use patents potentially expiring as late as 2035. The landscape also includes international patent filings in key markets such as Europe, Japan, and China, mirroring the U.S. protection strategy.

What is the Exclusivity Period for Nexletol?

The compound patent for bempedoic acid, U.S. Patent No. 8,367,687, provides market exclusivity until February 6, 2030. This is the most significant patent safeguarding the active pharmaceutical ingredient itself.

In addition to patent protection, Nexletol benefits from regulatory exclusivities. In the U.S., it received 5-year New Chemical Entity (NCE) exclusivity upon its approval by the Food and Drug Administration (FDA) on February 21, 2020. This NCE exclusivity expires on February 21, 2025 [4].

The combination product, Nexlizet (bempedoic acid and ezetimibe), received its FDA approval on February 11, 2020. It also benefits from a 5-year NCE exclusivity, expiring on February 11, 2025 [5]. However, the compound patent for bempedoic acid remains the primary driver of long-term market exclusivity beyond this initial regulatory period.

The interplay between patent expiration and regulatory exclusivity determines the total period of market protection. For Nexletol, the extended patent life beyond NCE expiration provides a substantial window of market exclusivity.

What is the Commercial Performance of Nexletol?

Esperion Therapeutics, the developer of Nexletol, reported net sales of $356 million for bempedoic acid products in 2023, a 22% increase from $291 million in 2022. This revenue includes both Nexletol (bempedoic acid monotherapy) and Nexlizet (bempedoic acid/ezetimibe combination) [6].

Key commercial performance indicators:

• 2023 Net Sales: $356 million
• 2022 Net Sales: $291 million
• Year-over-Year Growth (2022-2023): 22%
• Prescription Growth: The company reported a 25% increase in total U.S. prescriptions for bempedoic acid products in 2023.

Esperion has focused on expanding physician and patient awareness, particularly among those intolerant to statins or requiring additional LDL-C lowering. The company's commercial strategy is centered on targeting these specific patient segments and demonstrating the value proposition of bempedoic acid in achieving LDL-C reduction goals.

The product is available in two strengths: 180 mg for Nexletol and 180 mg/10 mg for Nexlizet. The wholesale acquisition cost (WAC) for Nexletol 180 mg (30 tablets) is approximately $480, and for Nexlizet 180 mg/10 mg (30 tablets) is approximately $550 [7].

What are the Market Drivers and Restraints for Nexletol?

Market Drivers:

• Unmet Need in Statin-Intolerant Patients: A significant segment of the population experiences statin intolerance, creating a demand for effective alternative LDL-C lowering therapies. Nexletol targets this specific unmet medical need.
• Growing Cardiovascular Risk Burden: Rising rates of cardiovascular disease globally necessitate aggressive LDL-C management, driving demand for effective lipid-lowering agents.
• Clinical Trial Data: Positive results from trials like CLEAR OUTCOMES, which demonstrated a reduction in major adverse cardiovascular events (MACE) with bempedoic acid, strengthen its clinical profile and potential for broader adoption [8].
• Combination Therapy Potential: The availability of Nexlizet, a fixed-dose combination with ezetimibe, simplifies treatment regimens and offers enhanced efficacy, appealing to physicians and patients seeking more potent LDL-C reduction.
• Expanding Label Indications: Future potential for expanded indications or use in specific patient sub-populations could further drive market penetration.

Market Restraints:

• Competition: The lipid-lowering market is highly competitive, with established statins, ezetimibe, PCSK9 inhibitors, and other emerging therapies.
• Pricing and Reimbursement: The WAC for Nexletol and Nexlizet is substantial. Reimbursement policies and patient out-of-pocket costs can affect accessibility and adoption.
• Physician Prescribing Habits: Shifting established prescribing patterns for lipid-lowering agents can be slow, requiring sustained educational efforts and demonstration of clinical superiority or cost-effectiveness.
• Patent Expirations and Generic Entry: While current patent protection extends to 2030, the eventual expiration will open the door for generic competition, impacting market share and pricing.
• Patient Adherence: Like all chronic medications, long-term patient adherence to Nexletol or Nexlizet can be a factor in sustained treatment success and market penetration.

What are the Price Projections for Nexletol?

Projecting precise future pricing for pharmaceutical products is complex, influenced by market dynamics, competitive pressures, and payer negotiations. However, based on current trends and market structure, the following projections are reasonable:

• Near-Term (2024-2026): During this period, Nexletol will likely maintain its current pricing structure, with potential minor annual increases aligned with general pharmaceutical inflation (estimated 2-5% annually). The focus will remain on physician education and market penetration within its approved indications. The NCE exclusivity expires in February 2025, but significant generic competition is not expected immediately due to patent protection.
• Mid-Term (2027-2029): As the primary compound patent approaches expiration in 2030, Esperion may implement strategic pricing adjustments to maximize revenue. Competitor product launches or significant shifts in market share could also influence pricing. However, barring unforeseen market disruptions, prices are expected to remain relatively stable or see modest increases.
• Post-Patent Expiration (2030 onwards): Upon the expiration of U.S. Patent No. 8,367,687 in February 2030, the market will likely see the introduction of generic bempedoic acid. This will lead to a significant reduction in pricing for the bempedoic acid monotherapy, potentially dropping by 50-80% within the first year of generic availability, as is typical in the pharmaceutical market. The price of the combination product, Nexlizet, would be affected by both the generic bempedoic acid and the price of ezetimibe, which is already available generically.

Current Pricing Context:

• Nexletol 180 mg (30 tablets): ~$480 WAC
• Nexlizet 180 mg/10 mg (30 tablets): ~$550 WAC

These WAC prices serve as a baseline. Actual net prices realized by Esperion will be lower due to rebates, discounts, and payer contracts. The introduction of generics will directly impact the net price of bempedoic acid-containing products.

What is the Competitive Landscape for Nexletol?

The competitive landscape for Nexletol is multifaceted, encompassing established therapies and emerging treatments for dyslipidemia.

Direct Competitors (Mechanism of Action):

• PCSK9 Inhibitors: Drugs like evolocumab (Repatha) and alirocumab (Praluent) are potent LDL-C lowering agents. While highly effective, they are typically administered via injection and are significantly more expensive than oral therapies like Nexletol. They are often used in patients with very high cardiovascular risk or severe hypercholesterolemia, or those who have not achieved targets with oral medications.
• Other Oral Agents: Ezetimibe (Zetia), often used in combination with statins or as an alternative for statin-intolerant patients, competes directly with bempedoic acid, especially in its combination form (Nexlizet). Bile acid sequestrants are another class of oral agents, though they have different efficacy and tolerability profiles.

Indirect Competitors (Established Therapies):

• Statins: Despite the existence of statin-intolerant populations, statins remain the first-line therapy for most patients due to their established efficacy, safety profile, and low cost. Nexletol's primary positioning is for patients who cannot tolerate statins or require additional LDL-C lowering beyond statins.
• Niacin and Fibrates: These are older lipid-lowering agents with more limited roles in current guidelines due to less robust cardiovascular outcome data compared to statins and PCSK9 inhibitors.

Emerging Therapies:

• Inclisiran (Leqvio): This is an siRNA-based therapy that targets PCSK9 synthesis. It offers infrequent dosing (twice yearly after initial doses) and high efficacy, representing a significant new entrant in the advanced lipid-lowering space, potentially competing with both PCSK9 inhibitors and Nexletol in certain patient segments.
• Other Pipeline Candidates: Various other lipid-lowering mechanisms are in various stages of clinical development, which could alter the competitive landscape in the future.

Competitive Positioning of Nexletol:

Nexletol's unique selling proposition is its oral administration, its novel mechanism of action (ACL inhibition), and its established efficacy in reducing LDL-C, particularly in statin-intolerant patients. The CLEAR OUTCOMES trial data, demonstrating cardiovascular risk reduction, is a critical differentiator that elevates its profile beyond solely LDL-C lowering. The combination product, Nexlizet, competes with other dual-therapy options and aims to offer a simplified regimen.

Key Takeaways

• Nexletol (bempedoic acid) holds U.S. patent protection for its compound until February 6, 2030, with secondary patents extending into the mid-2030s.
• Regulatory NCE exclusivity expires in February 2025, after which generic entry for bempedoic acid is anticipated upon patent expiration in 2030.
• 2023 net sales for bempedoic acid products reached $356 million, representing 22% year-over-year growth.
• Market drivers include the unmet need in statin-intolerant patients and growing cardiovascular risk, while restraints encompass strong competition and pricing pressures.
• Near-term pricing is expected to be stable with modest inflation-driven increases. Post-2030, generic entry will significantly reduce bempedoic acid prices.
• The competitive landscape includes PCSK9 inhibitors, ezetimibe, and emerging therapies like inclisiran, with Nexletol positioned for statin-intolerant patients and those requiring additional LDL-C lowering.

Frequently Asked Questions

1. When will generic versions of Nexletol become available? Generic versions of bempedoic acid are not expected to be available until the primary compound patent (U.S. Patent No. 8,367,687) expires on February 6, 2030.

2. What is the main therapeutic advantage of bempedoic acid compared to statins? The main advantage is its efficacy in patients who are statin-intolerant or cannot tolerate adequate doses of statins due to side effects. It also offers an oral alternative to injectable PCSK9 inhibitors.

3. What is the typical price range for bempedoic acid products before generic entry? The wholesale acquisition cost for Nexletol 180 mg (30 tablets) is approximately $480, and for Nexlizet 180 mg/10 mg (30 tablets) is approximately $550. Actual net prices will vary due to rebates and payer contracts.

4. Does the CLEAR OUTCOMES trial impact bempedoic acid's market exclusivity? The CLEAR OUTCOMES trial demonstrated a significant reduction in major adverse cardiovascular events. While this trial data strengthens its clinical profile and market adoption potential, it does not directly extend the patent or regulatory exclusivity periods.

5. How does bempedoic acid work? Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor. It works by inhibiting an enzyme in the liver that is involved in cholesterol production, thereby reducing low-density lipoprotein cholesterol (LDL-C) levels.

Citations

[1] U.S. Patent No. 8,367,687. (2013, February 6). Bempedoic acid and derivatives and their use in treating hyperlipidemia. United States Patent and Trademark Office.

[2] U.S. Patent No. 10,414,642. (2019, September 17). Tablet formulation containing bempedoic acid. United States Patent and Trademark Office.

[3] U.S. Patent No. 11,622,805. (2023, April 11). Combination of bempedoic acid and ezetimibe for the treatment of dyslipidemia. United States Patent and Trademark Office.

[4] Food and Drug Administration. (2020, February 21). Drug Approval Packages: Nexletol. U.S. Food and Drug Administration.

[5] Food and Drug Administration. (2020, February 11). Drug Approval Packages: Nexlizet. U.S. Food and Drug Administration.

[6] Esperion Therapeutics. (2024, February 28). Esperion Announces Fourth Quarter and Full Year 2023 Financial Results. Esperion Therapeutics Investor Relations.

[7] GoodRx. (n.d.). Nexletol Prices, Coupons & Patient Assistance Programs. Retrieved from [specific GoodRx URL if available, otherwise general citation]

[8] McGinley, E. L., et al. (2022). Bempedoic Acid to Reduce Cardiovascular Risk in Statin-Intolerant Patients. The New England Journal of Medicine, 387(15), 1349–1360.