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Last Updated: December 22, 2024

Terbutaline sulfate - Generic Drug Details


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What are the generic drug sources for terbutaline sulfate and what is the scope of freedom to operate?

Terbutaline sulfate is the generic ingredient in four branded drugs marketed by Novartis, Sanofi Aventis Us, Pharmacare, Areva Pharms, Chartwell Injectable, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Ani Pharms, Impax Labs, Lannett Co Inc, and Twi Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for terbutaline sulfate. Twelve suppliers are listed for this compound.

Summary for terbutaline sulfate
Drug Prices for terbutaline sulfate

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Recent Clinical Trials for terbutaline sulfate

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

SponsorPhase
The Emmes Company, LLCPhase 2/Phase 3
Duke HealthPhase 2/Phase 3
Kanecia Zimmerman, MD MPHPhase 2/Phase 3

See all terbutaline sulfate clinical trials

Medical Subject Heading (MeSH) Categories for terbutaline sulfate

US Patents and Regulatory Information for terbutaline sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 075877-001 Jun 26, 2001 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us BRICANYL terbutaline sulfate INJECTABLE;INJECTION 017466-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 Approved Prior to Jan 1, 1982 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

Expired US Patents for terbutaline sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms BRETHINE terbutaline sulfate TABLET;ORAL 017849-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Pharmacare BRETHINE terbutaline sulfate INJECTABLE;INJECTION 018571-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Ani Pharms BRETHINE terbutaline sulfate TABLET;ORAL 017849-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Terbutaline sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Terbutaline Sulfate

Introduction to Terbutaline Sulfate

Terbutaline sulfate is a bronchodilator used primarily in the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other respiratory conditions. It works by relaxing the muscles in the airways, making it easier to breathe.

Market Size and Growth

The global market for terbutaline sulfate is anticipated to experience significant growth over the coming years. According to market research, the terbutaline sulfate market is expected to develop revenue and achieve exponential market growth at a remarkable Compound Annual Growth Rate (CAGR) during the forecast period from 2024 to 2032[1].

Market Drivers

Several factors are driving the growth of the terbutaline sulfate market:

Increasing Prevalence of Respiratory Diseases

The rising incidence of asthma and COPD, particularly in urban areas due to air pollution, is a major driver. As the global population ages and urbanization increases, the demand for effective treatments like terbutaline sulfate is expected to rise.

Advancements in Inhalation Formulations

Innovations in inhalation formulations, such as nebulizer solutions and inhalers, have improved the delivery and efficacy of terbutaline sulfate. Companies like Joincare Pharmaceutical Group are investing heavily in research and development of high-barrier complex formulations, including inhalation products, which is further boosting the market[3].

Regulatory Approvals

Recent approvals of new inhalation products, such as the Tobramycin Inhalation Solution, indicate a favorable regulatory environment that supports the development and launch of new respiratory treatments. This trend is likely to continue, supporting the growth of terbutaline sulfate and similar drugs[3].

Financial Performance

Revenue and Profit Margins

The financial performance of companies involved in the production and distribution of terbutaline sulfate is robust. For instance, Joincare Pharmaceutical Group reported total revenues of RMB 17,143 million in 2022, representing a year-on-year increase of approximately 7.79%. The net profit attributable to shareholders also saw a significant increase of about 13.10% year-over-year[3].

Cash Flow and Asset Growth

The net cash flow from operating activities for Joincare Pharmaceutical Group increased by 55.19% year-over-year, reaching RMB 3,977 million in 2022. This indicates strong operational efficiency and financial health. The total assets of the company also grew by 14.87% year-over-year, reflecting expanded operations and investments in research and development[3].

Competitive Landscape

The market for terbutaline sulfate is competitive, with several pharmaceutical companies involved in its production and distribution. Key players are focusing on innovation, particularly in the area of inhalation formulations, to gain market share.

Research and Development

Companies are investing heavily in R&D to develop new and improved formulations. For example, Joincare Pharmaceutical Group had six products approved for launch, five products applied for production, and five products approved for clinical trials in 2022 alone[3].

Pricing and Cost Analysis

The pricing of terbutaline sulfate can vary depending on the formulation and the region. For instance, a terbutaline 1mg/mL 1ML injection can be priced around $184 in some healthcare settings[5].

Cost-Effectiveness

Terbutaline sulfate is generally considered cost-effective compared to other bronchodilators, especially when administered via inhalation. This cost-effectiveness, combined with its efficacy, makes it a preferred choice for many patients and healthcare providers.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of terbutaline sulfate. Regulatory approvals and compliance are essential for the launch and continued sale of the drug.

Recent Approvals

The approval of new inhalation products, such as the Tobramycin Inhalation Solution, highlights the regulatory support for innovative respiratory treatments. This favorable regulatory environment is expected to continue, supporting the growth of terbutaline sulfate and similar drugs[3].

Dose-Response and Efficacy

Clinical Studies

Clinical studies have demonstrated the efficacy of terbutaline sulfate in providing bronchodilation. A dose-response study showed that both 5-mg and 10-mg doses of terbutaline nebulizer solution were effective in convalescent asthmatic patients, although the higher dose caused mild tachycardia[2].

Patient Outcomes

The drug has been shown to improve patient outcomes by providing quick and effective relief from bronchospasm, making it a valuable treatment option for patients with respiratory conditions.

Global Market Trends

Regional Markets

The demand for terbutaline sulfate varies across different regions, with higher demand in areas with high prevalence of respiratory diseases. Urbanization and air pollution are significant factors influencing regional market trends.

Market Projections

The global market for terbutaline sulfate API is forecast to grow significantly by 2030, driven by increasing demand and advancements in formulation technology[4].

Challenges and Opportunities

Challenges

Despite the growth potential, the market faces challenges such as competition from other bronchodilators and the need for continuous innovation to stay ahead.

Opportunities

Opportunities exist in expanding into new markets, particularly in regions with growing healthcare needs. Investing in R&D to develop more efficient and cost-effective formulations is also a key opportunity.

Key Takeaways

  • The global terbutaline sulfate market is expected to grow significantly due to increasing prevalence of respiratory diseases and advancements in inhalation formulations.
  • Companies like Joincare Pharmaceutical Group are driving growth through robust financial performance and significant investments in R&D.
  • The regulatory environment is favorable, with recent approvals supporting the launch of new respiratory treatments.
  • Terbutaline sulfate remains a cost-effective and efficacious treatment option, supported by clinical studies.
  • Regional market trends and global projections indicate a bright future for the drug.

FAQs

What is terbutaline sulfate used for?

Terbutaline sulfate is used primarily in the treatment of asthma, COPD, and other respiratory conditions to provide bronchodilation.

How does terbutaline sulfate work?

It works by relaxing the muscles in the airways, making it easier to breathe.

What are the common formulations of terbutaline sulfate?

Common formulations include nebulizer solutions, inhalers, and injections.

What are the potential side effects of terbutaline sulfate?

Common side effects include mild tachycardia, especially with higher doses, and other minor cardiovascular effects.

How is the market for terbutaline sulfate expected to grow?

The market is expected to grow significantly at a remarkable CAGR from 2024 to 2032, driven by increasing demand and advancements in formulation technology.

Sources

  1. Global Terbutaline Sulfate Market Size, Trends and Projections - Market Research Intellect
  2. Terbutaline sulphate nebulizer solution: a dose-response study - PubMed
  3. JOINCARE PHARMACEUTICAL GROUP INDUSTRY CO., LTD ... - QQ Finance
  4. Terbutaline Sulphate API - Market Size - Valuates Reports
  5. AZ-General-Mesa-Chargemaster-07-01-2022.xlsx - Dignity Health

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