Last Updated: May 10, 2026

Amino acids - Generic Drug Details

Name: amino acids Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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.

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

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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
Baxter Hlthcare	PREMASOL 10% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	075880-002	Jun 19, 2003		RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hospira Inc	VEINAMINE 8%	amino acids; magnesium chloride; potassium acetate; potassium chloride; sodium acetate	INJECTABLE;INJECTION	017957-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Baxter Hlthcare	CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride	INJECTABLE;INJECTION	020678-002	Mar 26, 1997		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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
B Braun	HEPATAMINE 8%	amino acids	INJECTABLE;INJECTION	018676-001	Aug 3, 1982	3,950,529	⤷ Start Trial
Baxter Hlthcare	BRANCHAMIN 4%	amino acids	INJECTABLE;INJECTION	018678-001	Sep 28, 1984	4,438,144	⤷ Start Trial
Baxter Hlthcare	BRANCHAMIN 4% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018684-001	Sep 28, 1984	4,438,144	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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