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Last Updated: December 22, 2024

ISOETHARINE HYDROCHLORIDE - Generic Drug Details


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

Isoetharine hydrochloride is the generic ingredient in four branded drugs marketed by Nephron, Sanofi Aventis Us, Alpharma Us Pharms, Astrazeneca, Baxter Hlthcare, DEY, Intl Medication, Parke Davis, and Roxane, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for isoetharine hydrochloride.

Summary for ISOETHARINE HYDROCHLORIDE

US Patents and Regulatory Information for ISOETHARINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare ISOETHARINE HYDROCHLORIDE isoetharine hydrochloride SOLUTION;INHALATION 088144-001 Jul 29, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca ISOETHARINE HYDROCHLORIDE isoetharine hydrochloride SOLUTION;INHALATION 089618-001 Jun 13, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alpharma Us Pharms ISOETHARINE HYDROCHLORIDE isoetharine hydrochloride SOLUTION;INHALATION 087101-001 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

ISOETHARINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isoetharine Hydrochloride

Introduction

Isoetharine hydrochloride, a selective short-acting β2 adrenoreceptor agonist, was once a prominent drug in the treatment of bronchospasm and asthma. Here, we delve into its market dynamics and financial trajectory, exploring its rise, decline, and current status.

Historical Context

Isoetharine emerged as the third generation of β2 agonists, following epinephrine and isoprenaline. It was particularly popular in the late 1970s and early 1980s in the western United States for nebulization treatments to relieve airway spasm[1].

Market Peak and Usage

During its peak, isoetharine was the drug of choice for quick relief from bronchospasm and asthma. It was known for its rapid onset of action, providing relief within two to five minutes after administration. This made it highly effective for emergency treatments and acute asthma attacks[1].

Side Effects and Safety Concerns

Despite its efficacy, isoetharine had significant side effects, including increased heart rate, blood pressure, and other cardiac and central nervous system (CNS) effects. These side effects, although often transient, were a major concern and limited its long-term use[1].

Replacement by Newer Drugs

By the late 1980s, isoetharine was largely replaced by newer drugs such as orciprenaline (metaproterenol) and later by salbutamol (albuterol). These drugs offered longer durations of action and fewer cardiac side effects, making them more favorable for long-term management of asthma[1].

Financial Impact of Replacement

The replacement of isoetharine by newer drugs had a significant financial impact on its market. As practitioners and patients shifted to newer, more sustainable treatments, the demand for isoetharine decreased. This led to a decline in sales and revenue for the drug.

Economic Factors Influencing Trade

Global economic conditions, such as changes in trade policies and currency values, also affected the trade of isoetharine. For instance, the elimination of the American Selling Price (ASP) method of customs valuation in 1980 was expected to increase imports, but other economic factors like the rising U.S. dollar and declining demand by end-users offset these expectations[3].

Current Market Status

Today, isoetharine is no longer a dominant player in the asthma treatment market. However, it still maintains a niche role in treating severe shortness of breath that does not respond to newer bronchodilators. This limited use keeps it in the market, albeit at a much reduced scale compared to its peak[1].

Cost and Utilization Studies

Studies on healthcare costs and utilization have shown that the introduction of newer, more effective treatments has reduced the overall costs associated with asthma management. For example, school-based health center (SBHC) programs have demonstrated reduced hospitalization and emergency department visit rates, which indirectly reflect the decreased reliance on older drugs like isoetharine[2].

Regulatory and Legal Status

The regulatory status of isoetharine has remained relatively stable, but its use is heavily regulated due to its side effects. It is prescribed with caution, especially in patients with heart disease, high blood pressure, and other conditions[5].

Conclusion

Isoetharine hydrochloride's market dynamics and financial trajectory are marked by a rapid rise to prominence, followed by a decline as newer, safer drugs were introduced. While it still holds a niche in severe asthma treatment, its overall market presence and financial impact have significantly diminished.

Key Takeaways

  • Isoetharine was a leading drug for bronchospasm and asthma in the late 1970s and early 1980s.
  • It was replaced by newer drugs like orciprenaline and salbutamol due to fewer side effects and longer durations of action.
  • Economic factors such as trade policies and currency fluctuations affected its trade.
  • It maintains a limited role in treating severe asthma cases.
  • Regulatory caution is advised due to its side effects.

FAQs

What is isoetharine hydrochloride used for?

Isoetharine hydrochloride is used as a bronchodilator to relieve bronchospasm and asthma symptoms.

Why was isoetharine hydrochloride replaced by other drugs?

Isoetharine was replaced due to its significant side effects, including increased heart rate and blood pressure, and the availability of newer drugs with fewer side effects and longer durations of action.

What are the common side effects of isoetharine hydrochloride?

Common side effects include tremor, nervousness, shakiness, headache, nausea, lightheadedness, and difficulty in sleeping. It can also cause gastrointestinal issues and allergic reactions[5].

Is isoetharine hydrochloride still used today?

Yes, it is still used, albeit in a limited capacity, for treating severe shortness of breath that does not respond to newer bronchodilators.

What economic factors affected the trade of isoetharine hydrochloride?

Economic factors such as changes in trade policies, currency values, and declining demand by end-users affected its trade[3].

References

  1. Wikipedia: Isoetarine
  2. Interact for Health: FINAL REPORT Evaluation of Healthcare Costs and Utilization
  3. USITC: AN ASSESSMENT OF THE MULTILATERAL TRADE
  4. MDPI: Attacking COVID-19 Progression Using Multi-Drug Therapy
  5. Medindia: Isoetharine - Indications, Dosage, Side Effects and Precautions

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