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Last Updated: December 22, 2024

LABETALOL HYDROCHLORIDE Drug Patent Profile


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

Labetalol Hydrochloride is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience Speclts, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms. and is included in twenty-six NDAs.

The generic ingredient in LABETALOL HYDROCHLORIDE 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

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

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Summary for LABETALOL HYDROCHLORIDE
US Patents:0
Applicants:21
NDAs:26
Finished Product Suppliers / Packagers: 40
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 69
Patent Applications: 837
What excipients (inactive ingredients) are in LABETALOL HYDROCHLORIDE?LABETALOL HYDROCHLORIDE excipients list
DailyMed Link:LABETALOL HYDROCHLORIDE at DailyMed
Drug patent expirations by year for LABETALOL HYDROCHLORIDE
Recent Clinical Trials for LABETALOL HYDROCHLORIDE

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

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

See all LABETALOL HYDROCHLORIDE clinical trials

Pharmacology for LABETALOL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for LABETALOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for LABETALOL HYDROCHLORIDE

US Patents and Regulatory Information for LABETALOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rubicon LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 211953-003 Aug 18, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 212990-003 Sep 30, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unichem LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 212719-002 Aug 8, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE labetalol hydrochloride SOLUTION;INTRAVENOUS 213330-004 Nov 9, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074989-001 Sep 30, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unichem LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 212719-003 Aug 8, 2022 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

LABETALOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Labetalol Hydrochloride

Introduction to Labetalol Hydrochloride

Labetalol hydrochloride is a combined alpha- and beta-adrenoceptor blocking agent widely used in the management of hypertension and other cardiovascular conditions. Its unique pharmacological profile, which includes both alpha and beta blockade, makes it a versatile and effective medication for various hypertensive scenarios.

Market Drivers

Increasing Prevalence of Hypertension

The global labetalol market is significantly driven by the increasing prevalence of hypertension worldwide. Hypertension affects a substantial portion of the population and requires long-term management, leading to a consistent demand for effective antihypertensive medications like labetalol[1].

Growing Awareness About Cardiovascular Health

Increased awareness about the importance of cardiovascular health and the consequences of uncontrolled hypertension has resulted in higher rates of diagnosis and treatment. This heightened awareness drives the demand for medications such as labetalol, contributing to market growth[1].

Favorable Safety and Tolerability Profile

Labetalol is known for its favorable safety and tolerability profile compared to other antihypertensive drugs. It is well-tolerated by most patients, leading to higher patient adherence to treatment regimens, which in turn boosts market demand[1].

Growing Geriatric Population

The aging population is more prone to developing hypertension and related cardiovascular conditions. The growing geriatric population contributes to the increased demand for antihypertensive medications, including labetalol[1].

Market Restraints

Side Effects and Contraindications

Despite its efficacy, labetalol is associated with side effects such as low blood pressure with standing, dizziness, tiredness, and nausea. Serious side effects may include liver problems, heart failure, and bronchospasm. These side effects and contraindications limit its use in certain patient populations and pose restraints to market growth[2][4].

Availability of Alternative Medications

The presence of alternative antihypertensive medications also acts as a restraint. Patients and healthcare providers may opt for other medications with different side effect profiles or mechanisms of action, which can reduce the demand for labetalol[1].

Regional Analysis

The labetalol market is segmented into regions including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

  • North America: Currently dominates the market due to the high prevalence of hypertension and the presence of key market players[1].
  • Europe: Follows closely, with the growing aging population contributing to the demand for antihypertensive medications[1].
  • Asia Pacific: Expected to witness significant growth due to increasing healthcare expenditure, rising awareness about cardiovascular health, and a large population base[1].

Competitive Landscape

The competitive landscape of the labetalol market is characterized by several key players and opportunities for growth.

  • Market Players: Can capitalize on the growing demand for antihypertensive medications by providing effective and well-tolerated medications like labetalol[1].
  • Strategic Partnerships: Opportunities exist for strategic partnerships and collaborations to enhance product portfolios and expand market reach[1].

SWOT Analysis

Strengths

  • Labetalol is an effective antihypertensive medication with a favorable safety profile.
  • It is versatile in its use, including management of hypertensive emergencies, postoperative hypertension, and pregnancy-induced hypertension[1][2].

Weaknesses

  • Side effects and contraindications limit its use in certain patient populations.
  • It is a weaker β-blocker compared to other medications like propranolol[2][4].

Opportunities

  • Development of combination therapies and personalized medicine approaches.
  • Emphasis on long-acting formulations to enhance patient adherence to treatment[1].

Threats

  • Competition from alternative antihypertensive medications.
  • Stringent regulatory requirements[1].

Market Key Trends

Development of Combination Therapies

There is a growing trend towards the development of fixed-dose combination therapies for improved blood pressure control. This trend is expected to drive the market forward as it offers better patient outcomes and convenience[1].

Focus on Personalized Medicine

The market is shifting towards patient-centric approaches, including personalized medicine and tailored treatment regimens. This approach is likely to increase the demand for labetalol as it can be part of customized treatment plans[1].

Long-Acting Formulations

There is an emphasis on developing long-acting formulations to enhance patient adherence to treatment. This can lead to better blood pressure control and increased market demand for labetalol[1].

Financial Trajectory

The global labetalol hydrochloride API market is projected to grow significantly over the coming years.

  • Current Market Size: The global Labetalol Hydrochloride API market was valued at approximately USD 800 million in 2023[5].
  • Projected Growth: It is anticipated to reach an estimated USD 1.2 billion by 2032, indicating a substantial growth trajectory[5].

Impact of COVID-19

The COVID-19 pandemic has had a minimal negative impact on the labetalol market. Instead, the pandemic has highlighted the importance of cardiovascular health, leading to increased awareness and diagnosis of hypertension. This has driven the demand for antihypertensive medications, including labetalol, contributing to steady market growth[1].

Key Takeaways

  • The global labetalol market is driven by the increasing prevalence of hypertension and growing awareness about cardiovascular health.
  • Labetalol's favorable safety and tolerability profile and its versatility in treating various hypertensive conditions contribute to its market demand.
  • The market faces restraints such as side effects and the availability of alternative medications.
  • Regional growth is significant in North America, Europe, and the Asia Pacific.
  • The market is expected to grow significantly, driven by trends such as combination therapies and personalized medicine.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of labetalol hydrochloride? A: Labetalol hydrochloride is primarily used in the management of hypertension, including hypertensive emergencies, postoperative hypertension, and pregnancy-induced hypertension[2][4].

Q: What are the common side effects of labetalol? A: Common side effects include low blood pressure with standing, dizziness, tiredness, and nausea. Serious side effects may include liver problems, heart failure, and bronchospasm[2][4].

Q: How does labetalol hydrochloride work? A: Labetalol works by blocking the activation of β-receptors and α-receptors, leading to a decrease in peripheral vascular resistance and blood pressure with little alteration in heart rate or cardiac output[2][4].

Q: What is the projected market size of the global Labetalol Hydrochloride API market by 2032? A: The global Labetalol Hydrochloride API market is projected to reach an estimated USD 1.2 billion by 2032[5].

Q: What are the key trends driving the labetalol market? A: Key trends include the development of combination therapies, focus on personalized medicine, and emphasis on long-acting formulations to enhance patient adherence to treatment[1].

Sources:

  1. MarkWide Research: Global Labetalol market 2024-2032 | Size, Share, Growth.
  2. New Drug Approvals: Labetalol Hydrochloride, ラベタロール.
  3. Market Research Reports: Global Labetalol Hydrochloride API Market Research Report 2024.
  4. PubMed: Labetalol: a review of its pharmacology, pharmacokinetics, clinical use.
  5. DataIntelo: Labetalol Hydrochloride API Market Research Report 2032.

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