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. Ten 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:	51
Clinical Trials:	2
Patent Applications:	4,569
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1
Jaeb Center for Health Research	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
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982

International Patents for BRETHINE

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

Country	Patent Number	Title	Estimated Expiration
Sweden	335359
Denmark	468876
Denmark	135575
Netherlands	7513854
Finland	54798

Market Dynamics and Financial Trajectory for BRETHINE

Last updated: March 24, 2026

What is the current status of BRETHINE in the pharmaceutical market?

BRETHINE (terbutaline sulfate) is a bronchodilator used primarily for the management of asthma and bronchospasm. It functions by relaxing muscles in the airways, easing airflow. Its use as a short-term treatment has declined due to safety concerns and the availability of newer therapies. Despite this, BRETHINE remains prescribed, particularly in certain regions and specialty settings.

How does the regulatory environment influence BRETHINE's market position?

Recent regulatory shifts impact BRETHINE's market. Agencies such as the US FDA and the European Medicines Agency have issued warnings or restrictions following reports of adverse events, including cardiovascular risks. The FDA issued a Black Box Warning in 2011 regarding oral terbutaline, limiting its use to specific patients under strict monitoring. These regulations constrict market size and influence prescribing behaviors.

What clinical and market factors are affecting BRETHINE’s demand?

Clinical factors:

• Carcinogenic and cardiovascular safety concerns limit use.
• Inhaled formulations, with fewer systemic side effects, are preferred.
• Global guidelines now favor inhaled corticosteroids and beta-agonists with better safety profiles.

Market factors:

• Availability of newer inhalers like albuterol and levalbuterol.
• Shift toward fixed-dose combination inhalers.
• Limited manufacturing and distribution due to low demand in developed countries.

What are the key regions for BRETHINE's market?

United States:

• Usage declined post-2011 FDA warning.
• Prescriptions mainly in niche cases.
• Market value estimated below US$50 million annually as of 2022.

Europe:

• Similar decline due to safety concerns.
• Regulatory restrictions exist, but some use persists in hospitals and clinics.

Emerging markets:

• Rain regulations are less strict.
• BRETHINE remains used where alternatives are less accessible.
• Market potential exists but constrained by safety issues.

What does the competitive landscape look like?

The market is dominated by inhaled beta-agonists such as albuterol, levalbuterol, and salmeterol. Oral and parenteral therapies like BRETHINE have minimal share. No significant recent innovations involve BRETHINE currently, and newer drugs with better safety profiles replace it in many prescribed applications.

What is the financial outlook for BRETHINE?

Current financial trajectory:

• Revenue: Declining sharply since 2012.
• Sales: Estimated below US$50 million globally in 2022.
• Producing companies report low profitability margins; many have exited or minimized production.

Future projections:

• Market demand expected to shrink further in developed nations.
• Low appeal for R&D investment due to safety issues.
• Potential in specific niche markets with less regulation or where alternatives are unavailable.

Investment outlook:

• No current pipeline developments.
• Opportunities mainly limited to markets with regulatory laxity.
• Generic manufacturing likely to persist but with limited revenue growth.

What are the strategic considerations for stakeholders?

• Companies should evaluate the risk of litigation and regulatory restrictions.
• Focus on markets with less stringent oversight might sustain minimal revenue.
• Investing in safer, more effective alternatives offers better long-term prospects.

Key Takeaways

BRETHINE's market has contracted due to safety concerns and shifts toward inhaled therapies. It persists mainly in niche, less regulated markets. Financially, it faces declining revenues and limited growth prospects. Stakeholders should consider the regulatory environment, safety profile, and competitive landscape when engaging with BRETHINE. The drug's future appears limited outside specific contexts.

FAQs

1. What caused the decline of BRETHINE in the global market?
Safety concerns, particularly cardiovascular risks, led to regulatory restrictions and decreased prescribing, especially after the 2011 FDA Black Box Warning.

2. Are there any current manufacturing efforts for BRETHINE?
Manufacturing persists primarily for generic and niche uses, but no new formulations or significant R&D efforts are underway.

3. Can BRETHINE still be used for asthma management?
Yes, but in limited circumstances and under strict medical supervision, mainly where inhaled options are unavailable or unsuitable.

4. What are the main alternatives to BRETHINE?
Inhaled beta-agonists like albuterol and levalbuterol, as well as inhaled corticosteroids, constitute the primary alternatives with better safety profiles.

5. Is there potential for BRETHINE in emerging markets?
Yes, where regulatory restrictions are less strict, but overall demand remains low, and safety concerns persist.

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References

1. U.S. Food and Drug Administration. (2011). Black Box Warning for Terbutaline Sulfate. FDA Drug Safety Communications.
2. European Medicines Agency. (2015). Assessment report on terbutaline sulfate. EMA.
3. World Health Organization. (2020). Guidelines for Asthma Management. WHO.
4. IMS Health. (2022). Global Pharmaceutical Sales Data. IMS.
5. Pharmaceutical Market Intelligence. (2022). Beta-agonist and bronchodilator market analysis. PMI.