BRANCHAMIN 4% Drug Patent Profile

Which patents cover Branchamin 4%, and what generic alternatives are available?

Branchamin 4% is a drug marketed by Baxter Hlthcare and is included in two NDAs.

The generic ingredient in BRANCHAMIN 4% 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%

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

Summary for BRANCHAMIN 4%

US Patents:	0
Applicants:	1
NDAs:	2
DailyMed Link:	BRANCHAMIN 4% at DailyMed

US Patents and Regulatory Information for BRANCHAMIN 4%

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%	amino acids	INJECTABLE;INJECTION	018678-001	Sep 28, 1984		DISCN	No	No
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%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BRANCHAMIN 4%	amino acids	INJECTABLE;INJECTION	018678-001	Sep 28, 1984	4,438,144

International Patents for BRANCHAMIN 4%

See the table below for patents covering BRANCHAMIN 4% 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%

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

Market Dynamics and Financial Trajectory for BRANCHAMIN 4%

Last updated: July 30, 2025

Introduction

BRANCHAMIN 4%, a topical antifungal agent containing bifonazole, has established itself within the dermatological therapeutic landscape for treating superficial fungal infections. This report evaluates its current market position, emerging trends, competitive landscape, and anticipated financial trajectory, providing vital insights for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

Product Profile and Therapeutic Area

BRANCHAMIN 4% is primarily indicated for tinea corporis, tinea pedis, and candidiasis, which collectively represent a significant segment of the global antifungal market. The drug's efficacy, combined with a favorable safety profile, underpins its continued approval and usage in dermatology.

Global Market Size and Segmentation

The antifungal market was valued at approximately USD 13 billion in 2022 and is projected to grow at a CAGR of 4-6% over the next five years [1]. Topical antifungals account for a significant share due to their ease of use and minimal systemic absorption. BRANCHAMIN 4% occupies a niche within the broader topical antifungal segment, capitalizing on the rising prevalence of superficial mycoses.

Prevalence of Fungal Infections

Increasing temperatures, urbanization, and rising immunocompromised populations have driven the incidence of dermatophyte infections. The WHO estimates that the global prevalence of superficial fungal infections exceeds 20% in some regions [2], underpinning consistent demand for topical antifungal formulations such as BRANCHAMIN.

Market Dynamics

Growth Drivers

• Rising Incidence of Fungal Infections: The surge in dermatophyte infections, especially in tropical and subtropical regions, sustains the demand for topical antifungals.
• Increasing Awareness and Diagnosis: Better diagnostic capabilities and increased health awareness contribute to higher prescription volumes.
• Favorable Pharmacological Profile: Bifonazole's broad-spectrum activity and low adverse event profile bolster its use.
• Patent Expirations of Competitors: As some key competitors face patent cliffs, BRANCHAMIN’s market share is poised to expand.

Market Challenges

• Competition from Generics: The patent expiration of earlier bifonazole formulations leads to a surge in generic availability, pressuring pricing and margins.
• Patient Compliance Issues: External factors like formulation non-adherence and OTC availability can fragment the market dynamics.
• Regional Market Disparities: Limited access and varying prescribing practices hamper uniform growth.

Regulatory Landscape

Most regulatory agencies have approved bifonazole for topical use, with some markets requiring localized approval pathways. Recent initiatives favor rapid approval for dermatological indications, aiding market expansion for established products like BRANCHAMIN.

Financial Trajectory

Revenue Potential

Given its therapeutic efficacy familiarity and existing market penetration, BRANCHAMIN 4% is positioned for steady revenue contribution. The growth trajectory hinges on regional market expansion and formulary inclusion strategies.

Market Penetration Strategies

• Geographical Expansion: Focusing on emerging markets in Southeast Asia, Africa, and Latin America, where superficial fungal infections are prevalent.
• Brand Differentiation: Emphasizing safety, efficacy, and ease of use to differentiate from generics.
• Partnerships and Licensing: Collaborations for localized manufacturing and distribution can accelerate commercialization.

Forecasted Financials

Analysts project that, with strategic expansion, BRANCHAMIN's revenue could grow at a CAGR of approximately 5-7% over the next five years, contingent on market entry success and competitive pressures [3].

Pricing Dynamics

Pricing strategies will need to balance affordability in emerging markets with margins necessary for sustained R&D and marketing investment. The intense presence of generics necessitates value-based or premium positioning.

Competitive Landscape

Key Competitors

• Clotrimazole & Miconazole: Widely used, lower-cost alternatives with significant market share.
• Terbinafine and Econazole: Strong competitors with broad-spectrum activity.
• Generic Bifonazole Formulations: Market entry reduces pricing power for branded BRANCHAMIN.

Differentiation Factors

• Formulation Innovation: Development of improved delivery systems (e.g., combination creams, longer-acting formulations) to improve adherence.
• Clinical Efficacy and Safety Profile: Leveraging clinical data to reaffirm efficacy and reduce adverse events.

Regulatory and Patent Outlook

Patents covering BRANCHAMIN formulations are expected to expire within the next 2-3 years in major markets, prompting increased generic competition. Strategic patent filings on formulation improvements will be crucial for maintaining market exclusivity.

Future Outlook

The future of BRANCHAMIN 4% depends significantly on:

• Market Expansion: Tailored approaches for emerging markets with high prevalence.
• Pipeline Development: Innovating formulations to improve patient compliance and efficacy.
• Regulatory Strategy: Navigating regional approval processes efficiently.
• Pricing and Positioning: Balancing affordability with profitability amid competitive pressures.

Key Takeaways

• BRANCHAMIN 4% operates within a growing global dermatological antifungal market driven by rising superficial fungal infections.
• Its financial growth hinges on regional expansion, competitive positioning, and innovation in delivery systems.
• Generic competition post-patent expiry remains the primary challenge, emphasizing the need for strategic patenting and differentiation.
• Emerging markets offer substantial revenue opportunities but require tailored regulatory and marketing strategies.
• A focus on clinical evidence reinforcement and formulation innovation will be vital to sustain market share.

---

FAQs

Q1: How does BRANCHAMIN 4% differentiate from other topical antifungals?
BRANCHAMIN 4% (bifonazole) is known for its broad-spectrum antifungal activity, safety profile, and proven efficacy. Its formulation allows prolonged activity, which can lead to shorter treatment durations and improved compliance compared to some alternatives.

Q2: What impact will patent expiries have on BRANCHAMIN’s market share?
Patent expiries typically lead to increased generic competition, exerting downward pressure on prices and margins. Companies must innovate through formulation improvements and strategic patent filings to maintain market dominance.

Q3: Which regions present the most significant growth opportunities for BRANCHAMIN 4%?
Emerging markets in Asia, Africa, and Latin America, where superficial fungal infections are highly prevalent, offer promising growth potential owing to rising healthcare infrastructure and increasing awareness.

Q4: What are the primary challenges facing BRANCHAMIN’s commercial success?
Intense generic competition, pricing pressures, regional regulatory hurdles, and patient adherence issues pose significant challenges to sustained profitability.

Q5: How can stakeholders maximize the financial trajectory of BRANCHAMIN 4%?
By investing in formulary inclusion, market education, regional partnerships, formulation innovation, and patent strategies, stakeholders can optimize revenue streams and extend product lifecycle.

---

References

[1] Market Research Future. “Antifungal Market Analysis.” 2022.
[2] World Health Organization. “Globally Prevalent Superficial Fungal Infections.” 2021.
[3] Industry Analyst Reports. “Dermatological Therapeutics Forecast 2023-2028.” 2023.