BRETHAIRE Drug Patent Profile

When do Brethaire patents expire, and when can generic versions of Brethaire launch?

Brethaire is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in BRETHAIRE is terbutaline sulfate. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brethaire

A generic version of BRETHAIRE was approved as terbutaline sulfate by IMPAX LABS on June 26^th, 2001.

Summary for BRETHAIRE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	1
Patent Applications:	4,281
DailyMed Link:	BRETHAIRE at DailyMed

Recent Clinical Trials for BRETHAIRE

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

Sponsor	Phase
Yaakov Beilin	Phase 2/Phase 3

See all BRETHAIRE clinical trials

US Patents and Regulatory Information for BRETHAIRE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984		DISCN	No	No

Expired US Patents for BRETHAIRE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984	3,937,838
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984	4,011,258

International Patents for BRETHAIRE

See the table below for patents covering BRETHAIRE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	288356
Denmark	468876
Germany	1793759
Norway	124723
Spain	361433

BRETHAIRE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brethine (Terbutaline)

Introduction

Brethine, known generically as terbutaline, is a beta-2 adrenergic receptor agonist used to treat reversibly bronchospasm in asthmatic patients and those with bronchitis. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, healthcare providers, and patients.

Drug Approval and Generic Availability

Brethine was approved by the FDA prior to January 1, 1982, in oral tablet formulations of 2.5mg and 5mg. The drug has since seen the approval of several generic versions. Manufacturers such as Impax Labs, Lannett Co Inc, and TWI Pharmaceuticals have received FDA approval for their generic terbutaline sulfate tablets, ensuring a competitive market[1].

Market Competition and Entry Barriers

The pharmaceutical industry has seen a decrease in entry barriers over time, particularly for follow-on or 'me-too' drugs. This trend suggests that the development of drugs like terbutaline is often part of a competitive race rather than a post-hoc imitation. The median period of marketing exclusivity for breakthrough drugs has significantly decreased, from 10.2 years in the 1970s to 1.2 years in the late 1990s, indicating a more competitive market environment[3].

Pricing and Cost Considerations

The pricing of terbutaline and its generic versions is influenced by several factors, including production costs, market competition, and regulatory policies. Generic versions of Brethine are generally priced lower than the brand name, with costs ranging from $0.47 to $0.83 per tablet, depending on the manufacturer and dosage strength[4].

Impact of Regulatory Changes

The Inflation Reduction Act (IRA) introduced significant changes in the reimbursement structures for Medicare Part B drugs, which could impact the financial trajectory of terbutaline. The IRA mandates the negotiation of a “Maximum Fair Price” (MFP) for select single-source drugs, including those under Medicare Part B. This could lead to a reduction in add-on payments for providers, potentially affecting the revenue generated from these drugs. For example, the IRA could result in a 47.2% average reduction in add-on payments for providers administering Part B drugs, with potential reductions as high as 62.9% under a cost-recovery model[2].

Pharmacoeconomic Considerations

The pharmacoeconomic landscape for terbutaline involves balancing the costs of production, marketing, and distribution with the need to maintain profitability. The use of a cost-recovery model, where the Maximum Fair Price (MFP) is set to cover production costs plus a specified profit margin, could become more prevalent. This model is already used in some countries outside the US and may influence the pricing strategy for terbutaline and other drugs[2].

Global Market Presence

Terbutaline is marketed under various brand names globally, including Brethaire, Bricanyl, and others. The drug is available in multiple formulations such as tablets, inhalers, and injectable solutions, catering to different patient needs and preferences. This global presence helps in spreading the market risk and ensuring a stable financial trajectory[4].

Patient and Provider Impact

The availability of generic versions of Brethine has made the drug more accessible to patients, particularly those with chronic conditions like asthma. For healthcare providers, the negotiation of prices under the IRA and the subsequent reduction in reimbursement could shift financial risks, potentially affecting their prescribing habits and treatment strategies[2].

Financial Projections and Uncertainties

Given the regulatory changes and market dynamics, financial projections for terbutaline must account for potential reductions in reimbursement rates and increased competition from generic versions. The IRA's impact on Medicare Part B drugs will be a significant factor in these projections, as it could lead to substantial changes in the revenue streams for pharmaceutical companies and healthcare providers[2].

Competitive Strategies

To maintain market share and financial stability, pharmaceutical companies may need to adopt competitive strategies such as pricing adjustments, enhanced patient support programs, and innovative marketing approaches. The ability to demonstrate the value of their products through clinical data and patient outcomes will be crucial in a competitive and price-sensitive market[3].

Conclusion

The market dynamics and financial trajectory of Brethine (terbutaline) are influenced by a complex interplay of regulatory changes, generic competition, and pharmacoeconomic considerations. As the pharmaceutical landscape continues to evolve, understanding these factors is essential for navigating the challenges and opportunities presented by this drug.

Key Takeaways

• Generic Availability: Multiple generic versions of Brethine are available, increasing market competition.
• Regulatory Impact: The IRA's negotiation of Maximum Fair Prices could significantly reduce reimbursement rates for Medicare Part B drugs.
• Global Presence: Terbutaline is marketed under various brand names globally, ensuring a broad market reach.
• Pharmacoeconomic Considerations: Cost-recovery models may become more prevalent, affecting pricing strategies.
• Patient and Provider Impact: Increased accessibility for patients but potential financial risks for healthcare providers.

FAQs

Q: What is Brethine used for? A: Brethine (terbutaline) is used to treat reversibly bronchospasm in asthmatic patients and those with bronchitis.

Q: Are there generic versions of Brethine available? A: Yes, several generic versions of terbutaline sulfate tablets have been approved by the FDA[1].

Q: How does the Inflation Reduction Act (IRA) impact Brethine? A: The IRA could lead to a significant reduction in add-on payments for providers administering Medicare Part B drugs, including terbutaline[2].

Q: What are the potential financial implications for pharmaceutical companies? A: Companies may face reduced revenue due to lower reimbursement rates and increased competition from generic versions.

Q: How does the global market presence of terbutaline affect its financial trajectory? A: A global presence helps spread market risk and ensures a stable financial trajectory through diverse revenue streams[4].

Sources

1. Drugs.com - Generic Brethine Availability
2. Avalere - IRA Medicare Part B Negotiation Shifts Financial Risk to Physicians
3. PubMed - The economics of follow-on drug research and development
4. DrugBank - Terbutaline: Uses, Interactions, Mechanism of Action