BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Brevibloc Double Strength In Plastic Container, and when can generic versions of Brevibloc Double Strength In Plastic Container launch?

Brevibloc Double Strength In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brevibloc Double Strength In Plastic Container

A generic version of BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER was approved as esmolol hydrochloride by HIKMA on August 10^th, 2004.

Summary for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	16
Patent Applications:	732
DailyMed Link:	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

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

Sponsor	Phase
Zagazig University	Phase 2
Cristália Produtos Químicos Farmacêuticos Ltda.	Phase 4
University Hospital Bispebjerg and Frederiksberg	Phase 4

See all BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER clinical trials

Pharmacology for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

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

US Patents and Regulatory Information for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	AP	RX	Yes	Yes

Expired US Patents for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003

International Patents for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

See the table below for patents covering BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA03006229	FORMULACION DE ESMOLOL. (ESMOLOL FORMULATION.)
Japan	2010024249	ESMOLOL FORMULATION
Israel	151359	ESMOLOL FORMULATION
Turkey	200202557
European Patent Office	1368019	FORMULATION D'ESMOLOL (ESMOLOL FORMULATION)
Hungary	0204520

Market Dynamics and Financial Trajectory for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

Introduction to BREVIBLOC

BREVIBLOC, also known as esmolol hydrochloride, is a beta-1 selective adrenergic receptor blocker with a very short duration of action, making it ideal for the short-term treatment of tachycardia and hypertension, particularly in perioperative settings[1][4][5].

Market Demand and Clinical Use

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER is widely used in clinical settings for the immediate control of heart rate and blood pressure. Its use is prevalent in:

• Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia: It is effective in reducing heart rate and converting arrhythmias to normal sinus rhythm[1][4].
• Intraoperative and Postoperative Tachycardia and/or Hypertension: Its short half-life and rapid onset of action make it a preferred choice in surgical settings[1][4].

Competitive Landscape

The market for short-acting beta blockers is competitive, with other drugs like propranolol and metoprolol also being used. However, BREVIBLOC's unique pharmacokinetic profile, including its rapid onset and short duration of action, sets it apart. This makes it particularly valuable in acute care settings where quick and precise control over heart rate and blood pressure is crucial[5].

Financial Performance

The financial performance of BREVIBLOC DOUBLE STRENGTH can be gauged from several factors:

Sales and Revenue

BREVIBLOC has been a significant contributor to the revenue of its manufacturers, such as Baxter. The drug's widespread use in hospitals and surgical centers ensures a steady demand, translating into consistent sales figures. While exact revenue figures are not publicly disclosed in the provided sources, the drug's importance in clinical practice suggests it is a substantial revenue generator.

Pricing and Cost-Effectiveness

The pricing of BREVIBLOC DOUBLE STRENGTH is influenced by its concentration and the volume of the solution. For instance, the 100 mL Double Strength Premixed Injection bag contains 2000 mg of esmolol hydrochloride at a concentration of 20 mg/mL. The cost-effectiveness of BREVIBLOC lies in its ability to provide rapid and precise control over heart rate and blood pressure, reducing the need for prolonged hospital stays and additional treatments[2][5].

Market Growth

The market for BREVIBLOC is expected to grow due to several factors:

• Increasing Surgical Procedures: The rise in the number of surgical procedures, particularly in the elderly population, increases the demand for drugs like BREVIBLOC.
• Advancements in Healthcare: Improvements in healthcare infrastructure and the availability of advanced medical treatments also contribute to the growing demand.
• Regulatory Approvals: Continued regulatory approvals and updates, such as those from the FDA, ensure the drug remains a viable option for clinicians[1][4].

Challenges and Risks

Despite its market potential, BREVIBLOC faces several challenges:

Adverse Effects

The most common adverse effect of BREVIBLOC is hypotension, which can be symptomatic or asymptomatic. Other risks include bradycardia, cardiac failure, and infusion site reactions. These side effects necessitate careful patient monitoring and dose adjustment[1][4][5].

Contraindications

BREVIBLOC is contraindicated in patients with severe sinus bradycardia, cardiogenic shock, and those receiving vasoconstrictive drugs with positive inotropic effects. These contraindications limit its use in certain patient populations[1][4].

Drug Interactions

BREVIBLOC can interact with other medications, such as narcotic analgesics and inhalational anesthetics, which can enhance its hypotensive effects. This requires careful management and monitoring in clinical settings[4].

Future Outlook

The future outlook for BREVIBLOC DOUBLE STRENGTH is promising due to its unique pharmacological properties and the growing demand for short-acting beta blockers in acute care settings.

Innovations and Formulations

Continuous innovations in formulations, such as the ready-to-use premixed bags, enhance the convenience and safety of BREVIBLOC administration. These advancements are likely to maintain or increase market share[2][5].

Expanding Indications

Research into new indications and broader clinical applications could further expand the market for BREVIBLOC. For instance, its use in managing tachycardia in various clinical scenarios beyond the current approved indications could increase its market presence.

Key Takeaways

• Clinical Utility: BREVIBLOC DOUBLE STRENGTH is a valuable tool in managing tachycardia and hypertension, especially in perioperative settings.
• Market Demand: The drug's unique pharmacokinetics and widespread clinical use ensure a steady market demand.
• Financial Performance: Consistent sales and revenue are expected due to its critical role in acute care.
• Challenges and Risks: Careful patient monitoring and management of adverse effects are crucial.
• Future Outlook: Innovations and potential new indications are likely to sustain or grow its market presence.

FAQs

Q: What is the primary indication for BREVIBLOC DOUBLE STRENGTH?

A: The primary indication is for the short-term treatment of tachycardia and hypertension, particularly during induction and maintenance of anesthesia, and in the postoperative period[1].

Q: What are the common adverse effects of BREVIBLOC?

A: The most common adverse effects include hypotension, bradycardia, and infusion site reactions[1][4][5].

Q: Can BREVIBLOC be used in patients with severe sinus bradycardia?

A: No, BREVIBLOC is contraindicated in patients with severe sinus bradycardia as it may precipitate or worsen bradycardia[1].

Q: How is BREVIBLOC administered?

A: BREVIBLOC can be administered as a loading dose followed by a continuous infusion. It is available in ready-to-use premixed bags with concentrations of 10 mg/mL and 20 mg/mL[2][5].

Q: What are the storage conditions for BREVIBLOC DOUBLE STRENGTH?

A: BREVIBLOC should be stored at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F)[2].

Cited Sources

1. BREVIBLOC injection - accessdata.fda.gov
2. Dilution Esmolol - Brevibloc ® - GlobalRPH
3. BREVIBLOC injection - Baxter PI
4. PRODUCT MONOGRAPH - BREVIBLOC Injection esmolol ... - Baxter
5. brevibloc premixed injection - accessdata.fda.gov

Last updated: 2024-12-16