Is there a generic for Amikacin sulfate?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Amikacin sulfate, referencing the brand ARIKAYCE KIT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amikacin sulfate?

ARIKAYCE KIT (NDA 207356, INSMED INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Amikacin sulfate?

The Orange Book lists 14 patents against Amikacin sulfate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Amikacin sulfate have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Amikacin sulfate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Amikacin sulfate are approved?

Amikacin sulfate is approved in the following dosage forms: injectable, suspension, liposomal.

FDA Orange Book · active-ingredient family

Amikacin sulfate

Amikacin sulfate: 3 brands, 23 generics; first approved Sep 20, 1984; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 23 ANDA applications approved.

Earliest patent expiry Dec 05, 2026Latest exclusivity ends Sep 28, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 05, 2026

in 3 mo

Brand (NDA) products

Originator applications

ARIKAYCE KITRLDRS
INSMED INCNDA 2073562018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 590MG BASE/8.4ML SUSPENSION, LIPOSOMAL INHALATION Rx —
AMIKINRLD
APOTHECONNDA 050495—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APOTHECONNDA 05061819872 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued —
EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL	INHALATION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 5MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (23)

Abbreviated applications

AMIKACIN SULFATE
QILUANDA 2181462024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Rx AP
AMIKACIN SULFATE
SAGENT PHARMS INCANDA 2033232016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Rx AP
AMIKACIN SULFATE
FRESENIUS KABI USAANDA 2056052015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
FRESENIUS KABI USAANDA 2056042015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Rx AP
AMIKACIN SULFATERS
AVET LIFESCIENCESANDA 2040402013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Rx AP
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRAANDA 0641461997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 500MG BASE/100ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
IGI LABS INCANDA 0631671995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
IGI LABS INCANDA 0631691995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
HOSPIRAANDA 0640981995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
HOSPIRAANDA 0640991995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
ABBOTTANDA 0632651994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
HOSPIRAANDA 0632631994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
HOSPIRAANDA 0632641994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
ABBOTTANDA 0632661994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
HOSPIRAANDA 0632831994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 62.5MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATERS
HIKMAANDA 0633131994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx —
AMIKACIN SULFATE
HIKMAANDA 0633151994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Rx AP
AMIKACIN SULFATE
MEITHEALANDA 06404519932 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
EQ 250MG BASE/ML INJECTABLE INJECTION Rx AP
AMIKACIN SULFATE
HOSPIRAANDA 06335019932 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
HIKMAANDA 0632741992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKACIN SULFATE
HIKMAANDA 0632751992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKIN
APOTHECONANDA 06256219842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —
AMIKIN
APOTHECONANDA 062311—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued —
EQ 250MG BASE/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 62.5MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 250MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

ODE-214Orphan-drug exclusivity (7 years)
Sep 28, 2025
11 mo ago
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 28, 2030
in 4 yr 2 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8679532	Dec 05, 2026	in 3 mo	U-2415
8632804	Dec 05, 2026	in 3 mo	U-2416
8642075	Dec 05, 2026	in 3 mo	Product
8226975	Aug 15, 2028	in 2 yr	Product
9566234	Jan 18, 2034	in 7 yr 6 mo	ProductU-2415
10251900	May 15, 2035	in 8 yr 10 mo	U-2414
12377114	May 15, 2035	in 8 yr 10 mo	U-2414
9895385	May 15, 2035	in 8 yr 10 mo	U-2417
12016873	May 15, 2035	in 8 yr 10 mo	U-2414
10751355	May 15, 2035	in 8 yr 10 mo	U-2414
11446318	May 15, 2035	in 8 yr 10 mo	U-2414
12168022	May 15, 2035	in 8 yr 10 mo	U-2414
12168021	May 15, 2035	in 8 yr 10 mo	U-2414
12616708	May 15, 2035	in 8 yr 10 mo	U-2414

Approval history

FDA approval span

First approval

Sep 20, 1984

42 yr 6 mo ago

Most recent approval

Mar 19, 2024

2 yr 6 mo ago

Approvals span 1984–2024 across 26 FDA applications.

Brand (NDA) 312%

Generic (ANDA) 2388%

Amikacin sulfate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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