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Last Updated: December 22, 2024

BETAPACE Drug Patent Profile


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

Betapace is a drug marketed by Legacy Pharma and is included in two NDAs.

The generic ingredient in BETAPACE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Betapace

A generic version of BETAPACE was approved as sotalol hydrochloride by TEVA on May 1st, 2000.

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Summary for BETAPACE
Drug patent expirations by year for BETAPACE
Drug Prices for BETAPACE

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Drug Sales Revenue Trends for BETAPACE

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Recent Clinical Trials for BETAPACE

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

SponsorPhase
Beijing CTSmed Co. LtdPhase 4
Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePhase 4
Medtronic (Shanghai) Management Co. Ltd.Phase 4

See all BETAPACE clinical trials

Pharmacology for BETAPACE
Drug ClassAntiarrhythmic
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

US Patents and Regulatory Information for BETAPACE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Legacy Pharma BETAPACE sotalol hydrochloride TABLET;ORAL 019865-001 Oct 30, 1992 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Legacy Pharma BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151-007 Apr 2, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Legacy Pharma BETAPACE sotalol hydrochloride TABLET;ORAL 019865-003 Oct 30, 1992 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Legacy Pharma BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151-001 Feb 22, 2000 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Legacy Pharma BETAPACE sotalol hydrochloride TABLET;ORAL 019865-005 Apr 20, 1994 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Legacy Pharma BETAPACE sotalol hydrochloride TABLET;ORAL 019865-002 Oct 30, 1992 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Legacy Pharma BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151-006 Apr 2, 2003 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

BETAPACE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Betapace (Sotalol)

Introduction to Betapace (Sotalol)

Betapace, also known as sotalol, is a beta blocker used primarily for the treatment of life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) and atrial fibrillation. Here, we will delve into the market dynamics and financial trajectory of this crucial pharmaceutical product.

Market Drivers

The demand for sotalol is driven by several key factors:

Aging Population and Cardiovascular Diseases

The global aging population has led to an increase in the incidence of cardiovascular diseases, including arrhythmias. This demographic shift is a significant driver for the market growth of sotalol, as it is a proven treatment option for these conditions[4].

Awareness and Early Diagnosis

Heightened awareness of cardiac health and early diagnosis of arrhythmias have prompted more patients and healthcare providers to consider sotalol as a treatment option. This increased awareness has contributed to the market expansion[4].

Innovation in Drug Delivery Systems

Advancements in drug delivery systems, such as extended-release formulations, have enhanced patient compliance and convenience. These innovations make sotalol more accessible and user-friendly, further driving its adoption[4].

Market Segmentation and Share

The beta blockers market, which includes sotalol, is segmented based on type, application, and distribution channel.

Type

Beta blockers are categorized into beta-1 selective blockers and beta non-selective blockers. Sotalol falls under the beta non-selective category, which includes other drugs like labetalol and pindolol[1].

Application

The cardiac diseases application segment dominates the market, holding more than 65% of the share in 2022. Sotalol's primary use in treating life-threatening ventricular arrhythmias places it squarely within this segment[1].

Distribution Channel

The market is distributed through hospital pharmacies, retail pharmacies, and other channels. Hospital pharmacies are a significant distribution channel due to the critical nature of the conditions treated by sotalol[1].

Regional Market Analysis

The global beta blockers market, including sotalol, is analyzed across various regions:

North America

North America is expected to account for the largest share of the beta blockers market from 2023 to 2031. This is due to a well-established healthcare system and high awareness of cardiac health[1].

Europe

Europe also sees significant growth, driven by investments in research and development and the presence of a well-established healthcare system. Pharmaceutical companies in Europe are launching new formulations and combination therapies to enhance market share[1].

Asia Pacific

The Asia Pacific region is projected to grow at a significant pace, driven by the rise in geriatric population and the increasing prevalence of cardiovascular diseases. This region offers substantial opportunities for market expansion due to its large and growing patient base[1].

Financial Trajectory

The financial performance of the beta blockers market, including sotalol, is robust and growing.

Market Size and Growth Rate

The global beta blockers market is anticipated to reach more than US$ 14.4 billion by the end of 2031, with a Compound Annual Growth Rate (CAGR) of 5.2% from 2023 to 2031[1].

Research and Development Investments

Pharmaceutical companies are investing significantly in research and development to introduce new beta blockers with improved efficacy, safety, and tolerability. This investment is a key factor in the market's financial growth[1].

Revenue and Sales

Companies like Pfizer Inc., Novartis AG, and Teva Pharmaceutical Industries Ltd. are major players in the beta blockers market. These companies have seen steady revenue growth, partly due to the success of their beta blocker products, including sotalol[1].

Challenges and Considerations

While the market for sotalol is growing, there are several challenges and considerations:

Side Effects and Contraindications

Sotalol can cause serious side effects, including life-threatening ventricular arrhythmias associated with QT interval prolongation. It is contraindicated in patients with certain conditions, such as sick sinus syndrome, and requires careful monitoring and dose adjustment[5].

Compliance and Monitoring

The need for continuous electrocardiographic monitoring and the potential for adverse reactions like bradycardia and hypotension necessitate careful patient management. This can impact patient compliance and the overall market dynamics[5].

Key Players and Competitive Landscape

The beta blockers market, including sotalol, is fragmented with several key players:

  • Mylan N.V.
  • Novartis AG
  • Pfizer Inc.
  • Abbott
  • Teva Pharmaceutical Industries Ltd.
  • Amneal Pharmaceuticals LLC.
  • Sun Pharmaceutical Industries Ltd.
  • Lupin
  • ANI Pharmaceuticals, Inc.
  • Eagle Pharmaceuticals[1].

These companies are engaged in intense competition, with strategies including the launch of new formulations, combination therapies, and innovative drug delivery systems to capture market share.

Innovation and Future Trends

The future of the beta blockers market, including sotalol, is marked by several trends:

Personalized Medicine

There is a growing emphasis on personalized medicine, with treatments tailored to individual patient profiles. This approach enhances efficacy and minimizes side effects, driving the adoption of sotalol and other beta blockers[4].

Extended-Release Formulations

Innovations in extended-release formulations and improved dosage forms are expected to continue, enhancing patient compliance and convenience[4].

Key Takeaways

  • The demand for sotalol is driven by the aging population, increased awareness of cardiac health, and innovations in drug delivery systems.
  • The global beta blockers market, including sotalol, is expected to reach over US$ 14.4 billion by 2031 with a CAGR of 5.2%.
  • North America and Europe are significant markets, while the Asia Pacific region is expected to grow rapidly.
  • Major pharmaceutical companies are investing heavily in R&D to improve the efficacy and safety of beta blockers.
  • Despite growth, the market faces challenges related to side effects and the need for careful patient monitoring.

Frequently Asked Questions (FAQs)

Q: What is the primary use of Betapace (sotalol)? A: Betapace (sotalol) is primarily used for the treatment of life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) and atrial fibrillation.

Q: What are the key drivers of the sotalol market? A: The key drivers include the aging population, increased awareness of cardiac health, and innovations in drug delivery systems.

Q: Which region is expected to dominate the beta blockers market? A: North America is expected to account for the largest share of the beta blockers market from 2023 to 2031.

Q: What are the potential side effects of sotalol? A: Sotalol can cause serious side effects, including life-threatening ventricular arrhythmias associated with QT interval prolongation, bradycardia, and hypotension.

Q: How is the competitive landscape of the beta blockers market? A: The market is fragmented with several key players, including Mylan N.V., Novartis AG, Pfizer Inc., and others, who are engaged in intense competition through R&D and innovative product launches.

Cited Sources:

  1. Transparency Market Research: Beta Blockers Market Size, Share, Growth, Industry Report - 2031
  2. AHRQ Healthcare Horizon Scanning System: Status Update
  3. Bayer Annual Report 2014
  4. IMARC Group: Sotalol (Betapace) Manufacturing Plant Report: Setup & Cost
  5. FDA: Revised: 06/2023 - accessdata.fda.gov (Betapace/Betapace AF Label)

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