AMINO ACIDS - Generic Drug Details

What are the generic sources for amino acids and what is the scope of freedom to operate?

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.

There are seventeen drug master file entries for amino acids. Four suppliers are listed for this compound.

Summary for AMINO ACIDS

US Patents:	1
Tradenames:	139
Applicants:	8
NDAs:	55
Drug Master File Entries:	17
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
Abbott	AMINOSYN 3.5% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018804-001	May 15, 1984		DISCN	No	No
Icu Medical Inc	AMINOSYN 7% (PH6)	amino acids	INJECTABLE;INJECTION	017673-006	Nov 18, 1985		DISCN	No	No
Baxter Hlthcare	CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride	INJECTABLE;INJECTION	020678-019	Mar 26, 1997		RX	Yes	Yes
Icu Medical Inc	AMINOSYN 8.5% W/ ELECTROLYTES	amino acids; magnesium chloride; potassium phosphate, dibasic; sodium chloride	INJECTABLE;INJECTION	017673-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare	CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	020734-010	Sep 29, 1997		RX	No	No
Baxter Hlthcare	BRANCHAMIN 4%	amino acids	INJECTABLE;INJECTION	018678-001	Sep 28, 1984		DISCN	No	No
Icu Medical Inc	AMINOSYN II 5%	amino acids	INJECTABLE;INJECTION	019438-002	Apr 3, 1986		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