Assyro AI

FDA Orange Book · active-ingredient family

Amikacin sulfate

Amikacin sulfate is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARIKAYCE KIT · NDA 207356

3

Brand (NDA)

23

Generics (ANDA)

14

Listed patents

2

Exclusivity periods

Brand (NDA) products · injectable, suspension, liposomal

ProductApplicantApplicationTEApproved
ARIKAYCE KITRLDINSMED INCNDA 207356—Sep 28, 2018
AMIKINRLD×2APOTHECONNDA 050495—Approved Prior to Jan 1, 1982
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2APOTHECONNDA 050618—Nov 30, 1987

Generic (ANDA) products (23)

ProductApplicantApplicationTEApproved
AMIKACIN SULFATEQILUANDA 218146APMar 19, 2024
AMIKACIN SULFATESAGENT PHARMS INCANDA 203323APMay 12, 2016
AMIKACIN SULFATEFRESENIUS KABI USAANDA 205605—Dec 09, 2015
AMIKACIN SULFATEFRESENIUS KABI USAANDA 205604APDec 09, 2015
AMIKACIN SULFATEAVET LIFESCIENCESANDA 204040APDec 12, 2013
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRAANDA 064146—Apr 02, 1997
AMIKACIN SULFATEIGI LABS INCANDA 063167—Dec 14, 1995
AMIKACIN SULFATEIGI LABS INCANDA 063169—Dec 14, 1995
AMIKACIN SULFATEHOSPIRAANDA 064098—Jun 26, 1995
AMIKACIN SULFATEHOSPIRAANDA 064099—Jun 20, 1995
AMIKACIN SULFATEABBOTTANDA 063265—Nov 30, 1994
AMIKACIN SULFATEHOSPIRAANDA 063263—Nov 30, 1994
AMIKACIN SULFATEHOSPIRAANDA 063264—Nov 30, 1994
AMIKACIN SULFATEABBOTTANDA 063266—Oct 31, 1994
AMIKACIN SULFATEHOSPIRAANDA 063283—Oct 31, 1994
AMIKACIN SULFATEHIKMAANDA 063313—Apr 11, 1994
AMIKACIN SULFATEHIKMAANDA 063315APApr 11, 1994
AMIKACIN SULFATE×2MEITHEALANDA 064045—Sep 28, 1993
AMIKACIN SULFATE×2HOSPIRAANDA 063350—Jul 30, 1993
AMIKACIN SULFATEHIKMAANDA 063274—May 18, 1992
AMIKACIN SULFATEHIKMAANDA 063275—May 18, 1992
AMIKIN×2APOTHECONANDA 062562—Sep 20, 1984
AMIKIN×2APOTHECONANDA 062311—Approved Prior to Jan 1, 1982

Marketing exclusivity (2)

  • ODE-214Orphan-drug exclusivity (7 years)

    Sep 28, 2025

    9 mo ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Sep 28, 2030

    in 4 yr 4 mo

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8679532Dec 05, 2026in 6 mo
U-2415
8632804Dec 05, 2026in 6 mo
U-2416
8642075Dec 05, 2026in 6 mo
Product
8226975Aug 15, 2028in 2 yr 2 mo
Product
9566234Jan 18, 2034in 7 yr 8 mo
ProductU-2415
10251900May 15, 2035in 9 yr
U-2414
12377114May 15, 2035in 9 yr
U-2414
9895385May 15, 2035in 9 yr
U-2417
12016873May 15, 2035in 9 yr
U-2414
10751355May 15, 2035in 9 yr
U-2414
11446318May 15, 2035in 9 yr
U-2414
12168022May 15, 2035in 9 yr
U-2414
12168021May 15, 2035in 9 yr
U-2414
12616708May 15, 2035in 9 yr
U-2414

Amikacin sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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