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Last Updated: December 22, 2024

LABETALOL HYDROCHLORIDE IN DEXTROSE Drug Patent Profile


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When do Labetalol Hydrochloride In Dextrose patents expire, and what generic alternatives are available?

Labetalol Hydrochloride In Dextrose is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in LABETALOL HYDROCHLORIDE IN DEXTROSE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Labetalol Hydrochloride In Dextrose

A generic version of LABETALOL HYDROCHLORIDE IN DEXTROSE was approved as labetalol hydrochloride by HERITAGE PHARMA on August 3rd, 1998.

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Summary for LABETALOL HYDROCHLORIDE IN DEXTROSE
Drug patent expirations by year for LABETALOL HYDROCHLORIDE IN DEXTROSE
Recent Clinical Trials for LABETALOL HYDROCHLORIDE IN DEXTROSE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boston Medical CenterPhase 4
Marshall UniversityPhase 2
Loma Linda UniversityN/A

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Pharmacology for LABETALOL HYDROCHLORIDE IN DEXTROSE

US Patents and Regulatory Information for LABETALOL HYDROCHLORIDE IN DEXTROSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma LABETALOL HYDROCHLORIDE IN DEXTROSE labetalol hydrochloride SOLUTION;INTRAVENOUS 213330-001 Nov 9, 2020 RX Yes Yes ⤷  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

LABETALOL HYDROCHLORIDE IN DEXTROSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Labetalol Hydrochloride in Dextrose

Introduction

Labetalol hydrochloride in dextrose is a crucial medication in the management of severe hypertension, including acute hypertensive crises and severe hypertension in pregnancy. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Indications and Usage

Labetalol hydrochloride in dextrose is indicated for the treatment of severe hypertension to lower blood pressure quickly and effectively. It is particularly useful in emergency situations where rapid blood pressure reduction is necessary to prevent end-organ damage such as renal failure, hypertensive encephalopathy, or cardiac failure[2][4][5].

Competitive Landscape

The antihypertensive market is highly competitive, with various classes of drugs available, including beta-blockers, ACE inhibitors, calcium channel blockers, and more. However, labetalol hydrochloride stands out due to its unique dual-action mechanism, combining both alpha- and beta-adrenergic blockade. This makes it a preferred choice in certain clinical scenarios, particularly in acute settings where rapid and controlled blood pressure reduction is critical[3][5].

Market Demand

The demand for labetalol hydrochloride in dextrose is driven by the prevalence of severe hypertension, which can occur in various clinical settings, including emergency departments, intensive care units, and perioperative care. The drug's effectiveness in managing hypertensive emergencies, especially in pregnancy, further contributes to its demand[4].

Pricing and Cost Considerations

The pricing of labetalol hydrochloride in dextrose can vary based on the formulation, dosage, and geographical location. Generally, it is priced competitively within the antihypertensive market. The cost-effectiveness of labetalol, particularly when compared to other intravenous antihypertensive agents, is a significant factor in its market dynamics. Hospitals and healthcare providers often opt for labetalol due to its balanced pharmacological profile and the lack of significant adverse effects that could lead to additional healthcare costs[2][4].

Dosage Forms and Strengths

Labetalol hydrochloride in dextrose is available in various formulations, including ready-to-use solutions in single-dose bags of 200 mL containing 1 mg/mL of labetalol hydrochloride. This versatility in dosage forms helps in meeting different clinical needs and contributes to its market appeal[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of labetalol hydrochloride in dextrose. The drug has been approved by regulatory bodies such as the FDA and the Therapeutic Goods Administration (TGA) in Australia for the treatment of severe hypertension. Compliance with regulatory standards ensures the drug's safety and efficacy, which in turn influences its market acceptance and financial performance[2][4].

Financial Performance

The financial trajectory of labetalol hydrochloride in dextrose is influenced by several factors, including market demand, competition, pricing, and regulatory approvals. Given its established use in critical care settings and its effectiveness in managing severe hypertension, the drug has maintained a stable market presence.

  • Revenue Growth: The revenue generated from labetalol hydrochloride in dextrose has been steady, driven by its consistent use in hospitals and emergency departments.
  • Market Share: The drug holds a significant market share within the antihypertensive segment, particularly in the intravenous antihypertensive market.
  • Cost-Benefit Analysis: The cost-benefit analysis of labetalol hydrochloride in dextrose is favorable, as it provides effective blood pressure control with minimal adverse effects, reducing the overall healthcare cost in the long run[3][5].

Future Outlook

The future outlook for labetalol hydrochloride in dextrose remains positive due to several factors:

  • Increasing Prevalence of Hypertension: The global prevalence of hypertension is increasing, which is expected to drive the demand for effective antihypertensive medications.
  • Advancements in Clinical Use: Continued research and clinical studies may expand the indications for labetalol hydrochloride, further enhancing its market position.
  • Generic Competition: While generic versions of labetalol hydrochloride may enter the market, the brand name and established clinical efficacy of the original formulation are likely to maintain its market share[3][4].

Challenges and Opportunities

Despite its favorable market dynamics, there are challenges and opportunities to consider:

  • Generic Competition: The entry of generic versions could impact pricing and market share.
  • Innovative Formulations: Developing new formulations or delivery systems could enhance patient compliance and expand the drug's use.
  • Emerging Markets: Expanding into emerging markets where access to antihypertensive medications is limited could provide new revenue streams[2][4].

Key Takeaways

  • Labetalol hydrochloride in dextrose is a critical medication for managing severe hypertension.
  • Its unique dual-action mechanism sets it apart in the antihypertensive market.
  • The drug's market dynamics are influenced by its effectiveness, regulatory approvals, and competitive pricing.
  • The financial trajectory is stable, with potential for growth driven by increasing hypertension prevalence and expanding clinical use.

FAQs

Q: What is the primary indication for labetalol hydrochloride in dextrose? A: The primary indication is for the treatment of severe hypertension to lower blood pressure quickly and effectively.

Q: How does labetalol hydrochloride in dextrose differ from other antihypertensive medications? A: It combines both alpha- and beta-adrenergic blockade, making it unique in managing acute hypertensive crises without significant reflex tachycardia.

Q: What are the common side effects of labetalol hydrochloride in dextrose? A: Common side effects include symptomatic postural hypotension, gastrointestinal disturbances, tiredness, headache, and skin rashes[3].

Q: Is labetalol hydrochloride in dextrose contraindicated in any conditions? A: Yes, it is contraindicated in patients with bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, and hypersensitivity reactions to labetalol[2].

Q: How is labetalol hydrochloride in dextrose administered? A: It is administered as a slow continuous infusion at a rate of 2 mL/min or as an initial injection of 0.25 mg/kg followed by additional injections as needed[1][2].

Cited Sources

  1. FDA Label: Labetalol Hydrochloride Injection - Full Prescribing Information[1].
  2. FDA Label: Labetalol Hydrochloride in Sodium Chloride Injection and Labetalol Hydrochloride in Dextrose Injection[2].
  3. PubMed: Labetalol: a review of its pharmacology, pharmacokinetics, clinical efficacy, and tolerability[3].
  4. TGA AusPAR: Australian Public Assessment Report for Labetalol hydrochloride[4].
  5. StatPearls: Labetalol - NCBI Bookshelf[5].

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