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. 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%

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

International Patents for BRANCHAMIN 4%

See the table below for patents covering BRANCHAMIN 4% 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%

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
1318980	C 2015 053	Romania		PRODUCT NAME: PANOBINOSTAT SAU O SARE ACCEPTABILA FARMACEUTIC SAU UNDERIVAT AL ACESTUIAN-HIDROXI-3-[-[4-({[2-(2-METIL-1H-INDOL-3-IL)ETIL}AMINO}METIL)FENIL]]-2E-2-PROPENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF NATIONAL AUTHORISATION: 20150828; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF FIRST AUTHORISATION IN EEA: 20150828
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 the Drug: BRANCHAMIN 4%

Introduction

BRANCHAMIN 4%, an injectable amino acid solution, is a critical component in the medical field, particularly in parenteral nutrition. To understand its market dynamics and financial trajectory, we need to delve into various aspects including regulatory approvals, market trends, and financial considerations.

Regulatory Approval and Listing

BRANCHAMIN 4% has been approved by the FDA and is listed in the FDA's Orange Book, which provides detailed information on approved drug products in the United States. The drug is classified under the category of injectable solutions and is marketed by specific firms under their generic or trade names[1][4].

Market Classification

In the FDA's Orange Book, BRANCHAMIN 4% is categorized as a multisource drug product. This means it is available from more than one applicant, indicating a competitive market. The multisource category accounts for a significant portion of the drug products listed, with approximately 73% of the products falling into this category[1][4].

Market Trends

The approval and listing of BRANCHAMIN 4% reflect broader trends in the pharmaceutical market. Here are some key trends:

Approval and Addition of Drug Products

The FDA's quarterly reports show that new drug products, including those like BRANCHAMIN 4%, are continuously being added to the market. For instance, in a given quarter, several new drug products can be approved, and some may be removed due to various reasons such as withdrawal of approval or discontinued marketing[1][4].

Therapeutic Equivalence

BRANCHAMIN 4% is part of the therapeutically equivalent category, meaning it has the same active moiety and is interchangeable with other products in the same therapeutic class. This equivalence is crucial for ensuring that patients have access to effective and safe treatments[1][4].

Single vs. Multisource Products

The market dynamics also show a balance between single-source and multisource products. While single-source products are those marketed by a single firm, multisource products like BRANCHAMIN 4% are available from multiple firms. This competition can drive innovation and reduce costs[1][4].

Financial Considerations

Capital Structure and Financing

Financing drug development, including for products like BRANCHAMIN 4%, involves complex capital structures. For example, a dynamic leverage model can include equity, mezzanine, and senior debt tranches. This structure helps in managing the high costs associated with drug development and can enhance both scientific and financial outcomes[3].

Cost and Revenue Projections

The development and marketing of BRANCHAMIN 4% involve significant costs, including preclinical and clinical trial phases. Here is a general breakdown of the costs involved in drug development:

• Preclinical Phase: Approximately $5 million
• Phase I: Around $5 million
• Phase II: About $8 million
• Phase III: Around $43 million
• NDA and Approval: Significant costs associated with the New Drug Application (NDA) process[3].

The revenue generated from such products can be substantial, especially if they gain widespread acceptance and are included in standard treatment protocols.

Market Performance

The financial performance of BRANCHAMIN 4% would be influenced by its market acceptance, competition, and pricing strategies. In a competitive market, the product's pricing would need to be competitive while ensuring profitability. The revenue can also be affected by the number of patients treated and the frequency of use.

Industry Expert Insights

Industry experts often highlight the importance of a balanced capital structure and the need for continuous innovation in the pharmaceutical sector. For instance, dynamic leverage models can help in managing the financial risks associated with drug development while maximizing returns[3].

Illustrative Statistics

• Approval Rates: The FDA approves a significant number of new drug products each quarter, with some quarters seeing the approval of over 60 new products[1][4].
• Market Share: Multisource products, like BRANCHAMIN 4%, account for approximately 73% of the drug products listed in the FDA's Orange Book[1][4].
• Financial Projections: The total capital deployed in drug development can range from hundreds of millions to billions of dollars, with equity tranches often being the largest component[3].

Key Takeaways

• Regulatory Approval: BRANCHAMIN 4% is approved by the FDA and listed in the Orange Book.
• Market Classification: It is a multisource drug product, indicating competition in the market.
• Financial Considerations: The product's development and marketing involve complex capital structures and significant costs.
• Market Trends: The pharmaceutical market is dynamic, with continuous additions and removals of drug products.
• Expert Insights: A balanced capital structure and continuous innovation are crucial for success in the pharmaceutical sector.

FAQs

What is BRANCHAMIN 4% used for?

BRANCHAMIN 4% is an injectable amino acid solution used in parenteral nutrition, providing essential amino acids to patients who require intravenous nutrition.

How is BRANCHAMIN 4% classified in the FDA's Orange Book?

It is classified as a multisource drug product, meaning it is available from more than one applicant.

What are the key costs associated with the development of BRANCHAMIN 4%?

The costs include preclinical, Phase I, Phase II, and Phase III clinical trials, as well as the NDA process, totaling hundreds of millions of dollars.

How does the capital structure for drug development impact BRANCHAMIN 4%?

The capital structure, which can include equity, mezzanine, and senior debt tranches, helps manage the financial risks and can enhance both scientific and financial outcomes.

What are the market trends affecting BRANCHAMIN 4%?

The market trends include continuous approvals and additions of new drug products, competition among multisource products, and the importance of therapeutic equivalence.

Sources

1. DrugPatentWatch: FDA Orange Book Supplements[1].
2. IslamicMarkets: City Bank Annual Report 2018[2].
3. DSpace@MIT: Financing drug discovery via dynamic leverage[3].
4. DrugPatentWatch: FDA Orange Book Supplements[4].