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. Three 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	4,438,144

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
Australia	7456581
European Patent Office	0057209
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
1870100	122012000047	Germany		PRODUCT NAME: DABIGATRAN ETEXILAT MESILAT = 3-((2-((4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO)-METHYL)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO)-PROPIONSAEURE-ETHYLESTER-METHANSULFONAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2377536	92275	Luxembourg		PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720
2404919	CR 2016 00019	Denmark		PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCATBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOSYRE, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ELLER ET ESTERPRODRUG DERAF; REG. NO/DATE: EU/1/15/1059 20151124
1425001	SPC/GB14/034	United Kingdom		PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114

Market Dynamics and Financial Trajectory for BRANCHAMIN 4% IN PLASTIC CONTAINER

Introduction

BRANCHAMIN 4% IN PLASTIC CONTAINER is an injectable drug product that has been part of the pharmaceutical market for several decades. To understand its market dynamics and financial trajectory, it is crucial to delve into various aspects such as regulatory approvals, market trends, and financial performance indicators.

Regulatory Approval and Classification

BRANCHAMIN 4%, an amino acid solution, was approved by the FDA and is listed in the FDA's Orange Book, which catalogues approved drug products with therapeutic equivalence evaluations[1][4].

Drug Product Definition

For the FDA's Drug Product List, BRANCHAMIN 4% is defined as a representation of an active moiety (including molecular entity and its salts, esters, and derivatives) in a specific dosage form and strength for a given route of administration. It is marketed by firms under a particular generic or trade name[4].

Market Trends and Approval Activity

Quarterly and Monthly Activity

The FDA's Orange Book supplements provide insights into the quarterly and monthly activity of drug products, including approvals, removals, and category changes. For BRANCHAMIN 4%, the data shows that it has been part of the multisource product category, indicating that it is available from more than one applicant. This category is significant as it reflects competition in the market, which can influence pricing and availability[1][4].

New Molecular Entities and Therapeutic Equivalence

BRANCHAMIN 4% is not a new molecular entity but rather an established product. However, its inclusion in the multisource category means it has therapeutic equivalence evaluations, which are crucial for ensuring that generic or alternative versions of the drug are as effective as the original[4].

Financial Performance Indicators

Market Presence and Competition

The financial trajectory of BRANCHAMIN 4% is influenced by its market presence and competition. As a multisource product, it competes with other similar products, which can affect its pricing and market share. The presence of multiple applicants marketing this product suggests a competitive market, which can drive down costs and improve accessibility for patients[1][4].

Sales and Revenue

While specific sales and revenue data for BRANCHAMIN 4% are not readily available in the public domain, the overall trend in the pharmaceutical industry can provide some context. The sales of injectable amino acid solutions are generally stable, driven by consistent demand in clinical settings. However, revenue can fluctuate based on factors such as changes in reimbursement policies, competition from new products, and shifts in market demand.

Impact of Regulatory Changes

Prescription to Over-the-Counter Status

Changes in regulatory status, such as a switch from prescription to over-the-counter (OTC), can significantly impact the financial trajectory of a drug. However, BRANCHAMIN 4% remains a prescription-only product, which means its sales are more stable but also subject to stricter regulatory oversight[1][4].

Discontinued Marketing and Withdrawal of Approval

The FDA's reports also track products that are removed from the market due to withdrawal of approval or discontinued marketing. BRANCHAMIN 4% has not been subject to such actions, indicating a stable market presence[1][4].

Market Dynamics in the Pharmaceutical Industry

Generic Competition

The pharmaceutical industry is highly competitive, especially in the generic market. BRANCHAMIN 4% benefits from being a multisource product, which means multiple manufacturers can produce it. This competition can lead to lower prices and increased accessibility but also presents challenges in terms of market share and revenue[1][4].

Technological and Innovation Trends

Advancements in medical technology and innovation in drug delivery systems can impact the market dynamics of injectable solutions like BRANCHAMIN 4%. While the product itself may not have undergone significant changes, the broader industry trends towards more convenient and efficient delivery systems could influence its market position.

Financial Trajectory and Future Outlook

Stability and Consistency

Given its established presence and lack of significant regulatory changes, the financial trajectory of BRANCHAMIN 4% is likely to remain stable. The product's inclusion in the multisource category ensures a competitive market, which can maintain a consistent revenue stream.

Challenges and Opportunities

Despite stability, the product faces challenges from new entrants in the market and potential changes in healthcare policies. Opportunities lie in expanding its market reach through strategic partnerships and leveraging advancements in healthcare technology to enhance its delivery and administration.

Key Takeaways

• Regulatory Approval: BRANCHAMIN 4% is an FDA-approved injectable amino acid solution listed in the FDA's Orange Book.
• Market Trends: It is a multisource product with therapeutic equivalence evaluations, indicating competition and stability in the market.
• Financial Performance: The product's financial trajectory is influenced by its market presence, competition, and regulatory environment.
• Future Outlook: The outlook is stable, with potential for growth through strategic partnerships and technological advancements.

FAQs

What is BRANCHAMIN 4% used for?

BRANCHAMIN 4% is an injectable amino acid solution used for nutritional support in clinical settings.

Who manufactures BRANCHAMIN 4%?

BRANCHAMIN 4% is manufactured by multiple firms, including Travonol Labs, as it is a multisource product[1][4].

Is BRANCHAMIN 4% a new molecular entity?

No, BRANCHAMIN 4% is not a new molecular entity but an established product with therapeutic equivalence evaluations[4].

How does competition affect BRANCHAMIN 4%?

Competition from multiple manufacturers keeps the prices competitive and ensures accessibility, but it also challenges the product's market share and revenue.

What are the potential future challenges for BRANCHAMIN 4%?

Future challenges include new market entrants, changes in healthcare policies, and the need to adapt to technological advancements in drug delivery systems.

Sources

1. FDA Orange Book Supplements - DrugPatentWatch
2. City Bank Annual Report 2018 - IslamicMarkets.com
3. Mercantile Bank Limited Annual Report 2021 - IslamicMarkets.com
4. FDA Orange Book Supplements - DrugPatentWatch