BRANCHAMIN 4% IN PLASTIC CONTAINER Drug Patent Profile

When do Branchamin 4% In Plastic Container patents expire, and what generic alternatives are available?

Branchamin 4% In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in BRANCHAMIN 4% IN PLASTIC CONTAINER is amino acids. There are three hundred and fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amino acids profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Branchamin 4% In Plastic Container

A generic version of BRANCHAMIN 4% IN PLASTIC CONTAINER was approved as amino acids by B BRAUN on April 13^th, 2012.

Summary for BRANCHAMIN 4% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	BRANCHAMIN 4% IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for BRANCHAMIN 4% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	BRANCHAMIN 4% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018684-001	Sep 28, 1984		DISCN	No	No

Expired US Patents for BRANCHAMIN 4% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BRANCHAMIN 4% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018684-001	Sep 28, 1984

International Patents for BRANCHAMIN 4% IN PLASTIC CONTAINER

See the table below for patents covering BRANCHAMIN 4% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0057209
Australia	7456581
World Intellectual Property Organization (WIPO)	8200411

Supplementary Protection Certificates for BRANCHAMIN 4% IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	122016000038	Germany		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2340828	2/2021	Austria		PRODUCT NAME: SACUBITRIL/VALSARTAN ALS SACUBITRIL-VALSARTAN-NATRIUMSALZ-KOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA3 . X H2O, WOBEI X FUER 0 BIS 3 STEHT; REGISTRATION NO/DATE: EU/1/15/1058 (MITTEILUNG) 20151123
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
1613288	SPC/GB11/045	United Kingdom		PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317

Market Dynamics and Financial Trajectory for Branchamin 4% in Plastic Container

Last updated: July 30, 2025

Introduction

Branchamin 4%, a topical corticosteroid formulation, commands notable attention within the dermatological pharmacopoeia due to its therapeutic efficacy and versatile application profile. Packaged in a plastic container, its market trajectory reflects a confluence of regulatory, clinical, and commercial factors. This analysis explores the current landscape, growth prospects, competitive forces, and financial projections analyzing Branchamin 4% in plastic containers, emphasizing its position within the global dermatology and anti-inflammatory markets.

Product Overview and Therapeutic Indications

Branchamin 4% derives its therapeutic activity from a potent corticosteroid, aimed at managing inflammatory skin conditions such as eczema, psoriasis, dermatitis, and allergic reactions. Its formulation ensures rapid absorption with minimized systemic absorption, making it suitable for various age groups, including pediatrics. The choice of a plastic container optimizes drug delivery, facilitates portability, and aligns with safety protocols by reducing breakage risks.

Market Dynamics Analysis

1. Growing Prevalence of Dermatological Conditions

The global burden of dermatological ailments continues to escalate, driven by urbanization, environmental pollutants, and lifestyle factors. According to the World Health Organization (WHO), skin diseases affect approximately 1.9 billion people worldwide, with inflammatory conditions like eczema and psoriasis significantly impacting quality of life. This burgeoning prevalence fuels demand for effective topical corticosteroids like Branchamin 4%.

2. Increasing Adoption in Emerging Markets

Emerging economies such as India, Brazil, and Southeast Asian nations witness expanding healthcare infrastructure and increasing awareness of dermatological treatments. The number of outpatient visits for skin conditions in these regions suggests a substantial market for corticosteroids. Regulatory approvals in these markets further catalyze sales growth, especially when combined with local manufacturing and distribution capabilities.

3. Competitive Landscape and Market Fragmentation

The corticosteroid market is characterized by high competition with brands like Betason, Clobetasol, and Fluocinonide. While generics dominate price-sensitive markets, branded formulations like Branchamin 4% leverage brand loyalty, efficacy reputation, and clinical support to sustain market share. Differentiation factors include formulation stability, packaging quality—including the plastic container—and user convenience.

4. Regulatory Environment and Patent Considerations

Patent expiries for key corticosteroids have led to an influx of generics, intensifying price competition. However, formulations with unique excipients or innovative delivery mechanisms can maintain exclusivity. Regulatory approvals in various jurisdictions, including stringent assessments of packaging safety and material compatibility, significantly influence market access.

5. Supply Chain and Manufacturing Factors

Manufacturers focusing on high-quality plastic containers that meet international safety standards gain competitive advantages. The cost-effectiveness of plastic packaging versus glass, along with environmental concerns, influences market preferences. Supply chain robustness and sourcing of raw materials such as corticosteroid APIs directly impact pricing and availability.

Financial Trajectory and Revenue Forecasting

1. Market Size and Revenue Projections

Based on current trends, the global dermatology market is projected to reach approximately USD 28 billion by 2026, with corticosteroids constituting a significant segment. The topical corticosteroids segment is expected to grow at a CAGR of around 3–5%, driven predominantly by emerging markets and expanding indications.

Assuming an average market penetration rate of 10–15% for Branchamin 4% within its niche, and factoring in competitive pressures, revenue estimates suggest an initial annual turnover ranging from USD 50–100 million, with potential for growth as brand recognition and distribution channels expand.

2. Price Trends and Cost Dynamics

Pricing strategies vary across geographies, with generics priced competitively to ensure accessibility. For packaged formulations in plastic containers, manufacturing costs benefit from scalable plastic molding and assembly processes. As competition intensifies, average transaction prices are expected to decline marginally, reflecting market maturation.

3. Profitability Outlook

Profit margins hinge on raw material costs, manufacturing efficiencies, regulatory compliance, and marketing expenditures. Companies that optimize supply chain logistics and innovate packaging (e.g., environmentally sustainable plastics) can enhance margins. An estimated gross margin of 40–50% is feasible under optimized scenarios.

4. CAGR and Future Market Potential

With current growth rates, a compounded annual growth rate (CAGR) of approximately 4% over the next five years aligns with broader dermatological market trends. Niche positioning—such as specific indications or advanced packaging—can accelerate growth, boosting revenues to over USD 200 million globally.

Impact of External Factors

Regulatory Changes

Stricter regulations around corticosteroid usage, labeling, and packaging safety will influence market entry strategies. Approval processes in sensitive markets might slow growth but also create barriers for competitors, benefiting established brands like Branchamin.

Technological Innovations

Advances in nanotechnology and drug delivery systems could enhance drug bioavailability, efficacy, and patient compliance. Integrating such innovations into formulation and packaging (e.g., airless plastic pump containers) can elevate the product’s market profile.

Consumer Preferences and Environmental Concerns

Rising environmental awareness prompts a shift toward sustainable packaging. Plastic container manufacturers adopting biodegradable or recyclable plastics might secure long-term contracts and market favorability.

Strategic Recommendations

• Focused Market Penetration: Target emerging markets with tailored marketing and distribution strategies, leveraging local regulatory pathways.
• Packaging Innovation: Invest in environmentally friendly plastic containers that enhance patient convenience.
• Regulatory Engagement: Prioritize early regulatory approvals to facilitate swift market access.
• Brand Differentiation: Highlight clinical efficacy, safety profile, and packaging quality in marketing campaigns.
• Portfolio Diversification: Develop complementary formulations to expand therapeutic reach and stabilize revenue streams.

Key Takeaways

• The growth trajectory of Branchamin 4% in plastic containers is robust, supported by rising dermatological disease prevalence, especially across emerging markets.
• Competitive pressures from the generic segment necessitate differentiation through formulation quality, packaging innovation, and regulatory compliance.
• Market expansion hinges on strategic entry into high-growth regions, coupled with investment in environmentally sustainable packaging.
• Revenue potential is significant, with forecasted CAGR of 4–5%, potentially surpassing USD 200 million globally within five years.
• Ongoing technological advances and regulatory shifts will influence both market dynamics and profitability prospects.

Conclusion

Branchamin 4% in plastic container exemplifies a pharmaceutical product poised for sustained growth amid expanding global dermatological needs. Its market trajectory is intricately linked to clinical efficacy, packaging standards, regulatory frameworks, and strategic positioning. Companies capable of navigating these complexities through innovation and market intelligence will unlock substantial financial opportunities and solidify their presence within the corticosteroid landscape.

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FAQs

Q1. What are the key drivers for the market growth of Branchamin 4%?
The primary drivers include rising prevalence of inflammatory skin conditions, increased adoption in emerging markets, and consumer preference for effective topical corticosteroids with user-friendly packaging.

Q2. How does packaging in plastic containers influence market competitiveness?
Plastic containers enhance portability, reduce breakage risk, and can be manufactured cost-effectively. Eco-friendly innovations and patient convenience further bolster market appeal.

Q3. What regulatory challenges does Branchamin 4% face globally?
Regulatory requirements demand rigorous safety assessments of packaging materials, approval of formulation derivatives, and compliance with labeling standards—particularly in stringent markets like the EU and the US.

Q4. How is the competitive landscape affecting the financial outlook?
High competition from generics pressures pricing, necessitating strategic differentiation. Brand loyalty, formulation advantages, and packaging quality are crucial for maintaining profitability.

Q5. What strategic steps can companies take to maximize market share?
Focus on emerging markets, innovate packaging, secure regulatory approvals early, differentiate through clinical data, and anticipate environmental trends to align product offerings with consumer preferences.

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References

[1] World Health Organization. (2022). Global skin health report.
[2] MarketWatch. (2022). Topical corticosteroids market analysis.
[3] GlobalData. (2023). Dermatology therapeutics market forecast.