BRETHINE Drug Patent Profile

Which patents cover Brethine, and what generic alternatives are available?

Brethine is a drug marketed by Pharmacare and Ani Pharms and is included in two NDAs.

The generic ingredient in BRETHINE 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 Brethine

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

Summary for BRETHINE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	2
Patent Applications:	3,968
DailyMed Link:	BRETHINE at DailyMed

Recent Clinical Trials for BRETHINE

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

Sponsor	Phase
Yaakov Beilin	Phase 2/Phase 3
Jaeb Center for Health Research	Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1

See all BRETHINE clinical trials

US Patents and Regulatory Information for BRETHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for BRETHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982	3,937,838
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982	3,937,838
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982	4,011,258
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982	4,011,258

International Patents for BRETHINE

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

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

BRETHINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Brethine

Introduction

Brethine, known generically as terbutaline, is a medication used primarily to treat asthma and other respiratory conditions by relaxing smooth muscle tissue. Here, we will delve into the market dynamics and financial trajectory of Brethine, including its generic availability, market shifts, and legal implications.

Approval and Generic Availability

Brethine was approved by the FDA in its oral tablet form, with the original manufacturer being Novartis. However, Novartis transferred the New Drug Application (NDA) for Brethine to NeoSan Pharmaceuticals Inc. in December 2001[4].

Generic versions of Brethine have been approved and are available in the market. Manufacturers such as Impax Labs, Lannett Co Inc, and TWI Pharmaceuticals have received FDA approval for their generic terbutaline sulfate tablets in various strengths, including 2.5mg and 5mg[1].

Market Impact of Generic Versions

The introduction of generic versions significantly impacts the market dynamics of Brethine. Generic drugs are typically cheaper than their brand-name counterparts, which can lead to a decline in sales for the original brand. This shift is evident in the pharmaceutical industry, where generic competition often reduces the market share and revenue of the original drug.

Legal and Regulatory Considerations

Novartis's transfer of the NDA for Brethine to NeoSan Pharmaceuticals Inc. has led to legal implications. In a notable case, plaintiffs sued Novartis for negligence and negligent misrepresentation related to the off-label use of terbutaline during pregnancy, which allegedly caused neurological damage to the plaintiffs. The court held that Novartis could be liable for the actions of the new NDA holder, as it was reasonably foreseeable that the new holder might not update the labeling adequately[4].

Financial Trajectory

The financial performance of Brethine has been influenced by several factors, including the introduction of generic versions and changes in market ownership.

Decline in Brand Sales

With the availability of generic terbutaline, the sales of the brand-name Brethine have likely declined. This is a common scenario in the pharmaceutical industry where generic competition erodes the market share of the original brand.

Impact on Revenue

The revenue generated from Brethine would have decreased as generic versions gained market share. For instance, AstraZeneca's experience with generic competition, as seen in their annual reports, illustrates how the launch of generic medicines can lead to significant declines in sales for legacy drugs[3].

Market Dynamics and Competition

The market for respiratory medications is highly competitive, with multiple drugs available for treating similar conditions. The introduction of generic terbutaline has increased competition, making it harder for the brand-name Brethine to maintain its market position.

Off-Label Use and Controversies

The off-label use of terbutaline for premature labor, as highlighted in the legal case against Novartis, adds another layer of complexity to the market dynamics. Such uses can affect the drug's reputation and may lead to additional regulatory scrutiny[4].

Consumer and Healthcare Provider Impact

The availability of generic Brethine benefits consumers by providing a more affordable alternative for treating respiratory conditions. However, healthcare providers must be cautious about the potential risks associated with off-label uses and ensure that patients are aware of the generic options available.

Conclusion

The market dynamics and financial trajectory of Brethine are characterized by the impact of generic competition, legal considerations, and changes in market ownership. As the pharmaceutical landscape continues to evolve, understanding these factors is crucial for both manufacturers and healthcare providers.

Key Takeaways

• Generic versions of Brethine are available, impacting the brand's market share and revenue.
• Legal implications arise from the transfer of the NDA and off-label use of the drug.
• The introduction of generics benefits consumers by offering more affordable treatment options.
• Healthcare providers must be aware of the potential risks and benefits associated with generic and off-label uses.

FAQs

Q: What is Brethine used for?

Brethine, or terbutaline, is primarily used to treat asthma and other respiratory conditions by relaxing smooth muscle tissue.

Q: Are generic versions of Brethine available?

Yes, generic versions of Brethine have been approved and are available in the market from manufacturers such as Impax Labs, Lannett Co Inc, and TWI Pharmaceuticals[1].

Q: How has the introduction of generic Brethine affected the market?

The introduction of generic Brethine has led to increased competition, reducing the market share and revenue of the brand-name drug.

Q: What are the legal implications associated with Brethine?

Novartis has faced legal action related to the off-label use of terbutaline during pregnancy, highlighting the potential liability for the original NDA holder even after transferring the NDA to another company[4].

Q: How does the availability of generic Brethine impact consumers?

The availability of generic Brethine provides consumers with a more affordable treatment option for respiratory conditions, which can be beneficial in terms of cost savings.

Sources

1. Generic Brethine Availability - Drugs.com
2. iShares 0-5 Year TIPS Bond ETF - iShares
3. AstraZeneca Annual Report 2019 - AstraZeneca
4. T.H. v. Novartis Pharmaceuticals Corp. - Food and Drug Law Institute
5. Financing, Ambition, and Preparedness - NCBI