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Last Updated: December 23, 2024

KERLONE Drug Patent Profile


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Which patents cover Kerlone, and when can generic versions of Kerlone launch?

Kerlone is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in KERLONE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Kerlone

A generic version of KERLONE was approved as betaxolol hydrochloride by EPIC PHARMA on October 22nd, 1999.

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Summary for KERLONE
Drug patent expirations by year for KERLONE
Recent Clinical Trials for KERLONE

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SponsorPhase
Centre Hospitalier Universitaire de Saint EtiennePhase 4

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US Patents and Regulatory Information for KERLONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us KERLONE betaxolol hydrochloride TABLET;ORAL 019507-001 Oct 27, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us KERLONE betaxolol hydrochloride TABLET;ORAL 019507-002 Oct 27, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

KERLONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Kerlone

Introduction

Kerlone, known generically as betaxolol, is a selective beta1 receptor blocker used primarily in the treatment of hypertension and angina. To understand its market dynamics and financial trajectory, it is essential to delve into its clinical profile, market positioning, and the broader pharmaceutical industry trends.

Clinical Profile of Kerlone

Kerlone is a cardioselective adrenergic receptor blocking agent with no intrinsic sympathomimetic activity. It is characterized by its preferential effect on beta1 receptors, although it can also inhibit beta2 receptors at higher doses[4].

Pharmacokinetics and Metabolism

  • Kerlone has an absolute bioavailability of 89%, unaffected by food or alcohol consumption.
  • It is metabolized by the liver and eliminated primarily through the kidneys, with an elimination half-life of 14-22 hours[4].

Therapeutic Uses

Kerlone is effective in reducing resting and exercise heart rate, cardiac output, and cardiac workload. It is also used in combination with other antihypertensive agents like thiazide-type diuretics, methyldopa, hydralazine, and prazosin[4].

Market Positioning

Competitive Landscape

Kerlone competes in the beta-blocker market, which includes other drugs like atenolol and propranolol. Its cardioselectivity and lack of partial agonist activity make it a preferred choice for certain patients, particularly those with respiratory issues who might be sensitive to non-selective beta-blockers[4].

Pricing and Accessibility

The pricing of Kerlone can vary based on geographical location, insurance coverage, and the presence of generic alternatives. In general, beta-blockers are a well-established class of drugs, and their prices are often competitive due to the presence of multiple manufacturers.

Financial Trajectory

Revenue and Sales

The financial performance of Kerlone is tied to the overall demand for beta-blockers and the competitive dynamics within the cardiovascular drug market. While specific revenue figures for Kerlone are not publicly available, the drug's sales are influenced by factors such as prescription rates, insurance coverage, and the introduction of new or generic competitors.

Market Trends

The pharmaceutical industry is subject to various trends that can impact the financial trajectory of drugs like Kerlone:

  • Generic Competition: The availability of generic versions of beta-blockers can significantly reduce the market share and revenue of branded drugs like Kerlone.
  • Innovative Therapies: The development of new cardiovascular treatments can shift market preferences and impact the sales of established drugs.
  • Regulatory Environment: Changes in regulatory policies, such as those related to drug pricing or reimbursement, can affect the financial performance of pharmaceutical companies[5].

Industry Insights and Challenges

Pharmaceutical Market Dynamics

The pharmaceutical industry is characterized by high research and development costs, stringent regulatory requirements, and intense competition. For drugs like Kerlone, maintaining market share requires continuous marketing efforts, strategic partnerships, and sometimes, the development of new formulations or indications.

Economic Factors

Economic conditions, such as changes in interest rates and healthcare policies, can influence the financial health of pharmaceutical companies. For instance, rising interest rates can increase the cost of capital for these companies, potentially affecting their ability to invest in research and development or marketing[5].

Patient and Prescriber Preferences

Patient Compliance

Patient compliance is a critical factor in the long-term success of any medication. Kerlone's once-daily dosing regimen and relatively favorable side effect profile can enhance patient compliance compared to drugs with more complex dosing schedules or severe side effects[4].

Prescriber Preferences

Prescribers often prefer drugs with a well-established safety and efficacy profile. Kerlone's selective beta1 blocking activity and lack of intrinsic sympathomimetic activity make it a preferred choice for certain patient populations, particularly those with specific comorbidities.

Future Outlook

Market Growth

The market for cardiovascular drugs is expected to grow due to increasing prevalence of hypertension and other cardiovascular diseases. However, this growth will be influenced by the introduction of new therapies, changes in healthcare policies, and the availability of generic alternatives.

Competitive Strategies

To maintain its market position, the manufacturer of Kerlone may need to adopt competitive strategies such as:

  • Diversification: Expanding the drug's indications or developing new formulations.
  • Marketing and Education: Enhancing prescriber and patient awareness about the benefits of Kerlone.
  • Partnerships: Collaborating with other pharmaceutical companies or healthcare providers to improve market reach.

Key Takeaways

  • Kerlone is a selective beta1 receptor blocker with a well-established clinical profile.
  • Its market positioning is influenced by its cardioselectivity and lack of partial agonist activity.
  • The financial trajectory of Kerlone is affected by industry trends, regulatory changes, and economic factors.
  • Patient compliance and prescriber preferences play crucial roles in the drug's long-term success.
  • The future outlook for Kerlone involves navigating a competitive market with potential growth opportunities in the cardiovascular drug sector.

FAQs

What is Kerlone used for?

Kerlone is used primarily in the treatment of hypertension and angina.

How does Kerlone differ from other beta-blockers?

Kerlone is a cardioselective beta-blocker, meaning it preferentially blocks beta1 receptors, which are mainly found in the heart. This makes it a better option for patients with respiratory issues compared to non-selective beta-blockers.

What are the common side effects of Kerlone?

Common side effects include bradycardia, hypotension, and fatigue. At higher doses, it can also affect beta2 receptors, leading to bronchospasm or peripheral vasoconstriction[4].

Can Kerlone be used during pregnancy?

Kerlone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers can reduce placental perfusion and may cause adverse effects in the fetus and neonate[4].

How does Kerlone interact with other medications?

Kerlone can be used concurrently with thiazide-type diuretics, methyldopa, hydralazine, and prazosin. However, it is important to monitor for potential interactions, especially with drugs that affect the cardiovascular system[4].

Sources

  1. Wikipedia: Betaxolol
  2. FS KKR Capital Corp.: Debt Investor Presentation
  3. U.S. Department of Justice: The High Point Drug Market Intervention Strategy
  4. FDA: KerloneĀ® Label
  5. S&P Global: U.S. Leveraged Finance Q2 2024: Credit Trends Generally Positive, But First-Lien Recovery Prospects Still Under Pressure

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