Amino acids - Generic Drug Details

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What are the generic drug sources for amino acids and what is the scope of patent protection?

Amino acids is the generic ingredient in one hundred and thirty-nine branded drugs marketed by Hospira, B Braun, Icu Medical Inc, Abbott, Otsuka Icu Medcl, Baxter Hlthcare, Hospira Inc, and Fresenius Kabi Usa, and is included in fifty-five NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for amino acids

US Patents:	1
Tradenames:	139
Applicants:	8
NDAs:	55
Finished Product Suppliers / Packagers:	4
DailyMed Link:	amino acids at DailyMed

Pharmacology for amino acids

Drug Class

Amino Acid

Anatomical Therapeutic Chemical (ATC) Classes for amino acids

B05BA	Solutions for parenteral nutrition
B05B	I.V. SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for amino acids

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	020734-017	Sep 29, 1997		RX	No	No
Hospira Inc	AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride	INJECTABLE;INJECTION	019683-003	Nov 7, 1988		DISCN	No	No
Abbott	AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride	INJECTABLE;INJECTION	019714-004	Sep 12, 1988		DISCN	No	No
Baxter Hlthcare	CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	020734-016	Sep 29, 1997		RX	No	No
Baxter Hlthcare	CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	020734-015	Sep 29, 1997		RX	No	No
Icu Medical Inc	AMINOSYN II 10% W/ ELECTROLYTES	amino acids; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride	INJECTABLE;INJECTION	019437-004	Apr 3, 1986		DISCN	No	No
Baxter Hlthcare	TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER	amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride	INJECTABLE;INJECTION	020147-004	Oct 23, 1995		DISCN	No	No

Expired US Patents for amino acids

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
B Braun	HEPATAMINE 8%	amino acids	INJECTABLE;INJECTION	018676-001	Aug 3, 1982
Baxter Hlthcare	BRANCHAMIN 4% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018684-001	Sep 28, 1984