Esperion Receives Five Year Patent Extension for Bempedoic Acid, Contained in NEXLETOL® and NEXLIZET®
Esperion (NASDAQ: ESPR) has announced that the U.S. Patent and Trademark Office (USPTO) granted a five-year Patent Term Extension (PTE) for bempedoic acid, the key ingredient in NEXLETOL® and NEXLIZET® tablets. This extension extends U.S. Patent No. 7,335,799 through December 3, 2030. Bempedoic acid is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who cannot take recommended statin therapy. It is also used to lower LDL-C in adults with primary hyperlipidemia. The PTE will be included in the FDA's Orange Book, enhancing the market exclusivity of the drug. Important safety information includes the risk of hyperuricemia and tendon rupture, among other adverse reactions.
- Patent extension for bempedoic acid until December 3, 2030.
- Enhances market exclusivity of NEXLETOL® and NEXLIZET®.
- Indicated to reduce risk of myocardial infarction and coronary revascularization.
- Helps lower LDL-C in adults with primary hyperlipidemia.
- Bempedoic acid can cause hyperuricemia, increasing the risk of gout.
- Associated with an increased risk of tendon rupture.
- Common adverse reactions include upper respiratory tract infections, muscle spasms, and elevated liver enzymes.
Insights
Esperion's patent extension for bempedoic acid, which extends through December 3, 2030, is a significant development from a financial perspective. A patent extension effectively provides market exclusivity for NEXLETOL and NEXLIZET, protecting them from generic competition for five additional years.
This extension allows Esperion to maintain higher pricing power and margins on these drugs. Given the competitive nature of the pharmaceutical industry, longer patent protection can translate into sustained revenue streams, which is important for investor confidence and stock price stability. Investors should consider this as a positive signal for Esperion's future revenue forecasts, as it ensures a prolonged period of unchallenged market presence for these products.
Furthermore, it's important to note that the extension was granted under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984, which aims to balance between promoting innovation and facilitating generic drug market entry. This ensures that Esperion has legally sound protection for its intellectual property.
The patent extension for bempedoic acid, the active component of NEXLETOL and NEXLIZET, is noteworthy from a clinical and market perspective. These medications target patients with cardiovascular disease who cannot tolerate statins, addressing a significant unmet need in lipid management. The extension ensures that these patients will continue to have access to these treatments without interruption for a longer period.
In terms of clinical impact, long-term studies and patient outcomes can be better assessed over the extended patent period, potentially leading to new indications or improved treatment protocols. This could enhance the drug's profile and position in the market, especially as providers aim to lower LDL-cholesterol levels aggressively.
However, investors should be aware of potential safety issues such as hyperuricemia and tendon rupture associated with bempedoic acid. These side effects are critical in clinical decision-making and could impact market uptake if they are perceived as significant risks by healthcare providers.
The extension's impact on the market positioning of NEXLETOL and NEXLIZET is considerable. By securing exclusivity until 2030, Esperion can focus on marketing strategies to expand its market share without the immediate threat of generic competition. This can involve increasing penetration in existing markets and exploring new markets where the prevalence of cardiovascular diseases is high.
From a market dynamics perspective, the extension provides Esperion a leverage point against competitors. This allows them to build stronger relationships with key stakeholders, including healthcare providers and payers, who play a critical role in drug adoption and reimbursement decisions.
Additionally, the extension can align with future pipeline products, creating a synergistic effect that boosts overall company valuation and market perception. Investors should watch how Esperion leverages this patent extension in its broader market strategy.
ANN ARBOR, Mich., May 14, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announced today that the U.S. Patent and Trademark Office (USPTO) issued a U.S. Patent Term Extension (PTE) certificate for bempedoic acid, which is contained in NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets. The certificate extends the term of U.S. Patent No. 7,335,799 by five years through December 3, 2030. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.
This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).
INDICATION
NEXLIZET and NEXLETOL are indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥
Adverse reactions reported in ≥
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
investorrelations@esperion.com
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FAQ
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