AMINO ACIDS - Generic Drug Details

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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, Baxter Hlthcare, Hospira Inc, and Fresenius Kabi Usa, and is included in fifty-five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for AMINO ACIDS

US Patents:	0
Tradenames:	139
Applicants:	7
NDAs:	55
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	3
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

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Glossary

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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% W/ DEXTROSE 25% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	019118-001	Oct 11, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbott	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	019713-006	Sep 9, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	KABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656-004	Aug 25, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AMINO ACIDS

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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	⤷ Sign Up	⤷ Sign Up
B Braun	HEPATAMINE 8%	amino acids	INJECTABLE;INJECTION	018676-001	Aug 3, 1982	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	BRANCHAMIN 4% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018684-001	Sep 28, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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