Labetalol hydrochloride - Generic Drug Details

What are the generic drug sources for labetalol hydrochloride and what is the scope of patent protection?

Labetalol hydrochloride is the generic ingredient in five branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience Speclts, Schering, Sebela Ireland Ltd, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Rubicon, Sandoz, Teva, Unichem, Watson Labs, Zydus Pharms, and Alvogen, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for labetalol hydrochloride. Forty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for labetalol hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	24
NDAs:	30
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	69
Patent Applications:	1,197
What excipients (inactive ingredients) are in labetalol hydrochloride?	labetalol hydrochloride excipients list
DailyMed Link:	labetalol hydrochloride at DailyMed

Recent Clinical Trials for labetalol hydrochloride

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

Sponsor	Phase
Boston Medical Center	Phase 4
Marshall University	Phase 2
Loma Linda University	N/A

See all labetalol hydrochloride clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		5MG/ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for labetalol hydrochloride

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for labetalol hydrochloride

Adrenergic alpha-1 Receptor Antagonists

Adrenergic beta-Antagonists

Antihypertensive Agents

Sympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for labetalol hydrochloride

C07AG	Alpha and beta blocking agents
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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
Endo Operations	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	200908-002	Jul 10, 2012	AB	RX	No	Yes
Hibrow Hlthcare	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	207863-001	Feb 4, 2019	AB	RX	No	No
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984		DISCN	Yes	No
Hibrow Hlthcare	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	207863-003	Feb 4, 2019	AB	RX	No	No
Cadila Pharms Ltd	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	211325-002	May 13, 2019	AB	RX	No	No
Appco	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	209603-004	Oct 18, 2024		RX	No	No

Expired US Patents for labetalol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987	4,066,755
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	4,012,444
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	4,012,444
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984	4,012,444
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984	4,066,755
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-004	Aug 1, 1984	4,066,755

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.