Orange Book product · Brand (NDA)
ARIKAYCE KIT
AMIKACIN SULFATE
At a glance
Sep 28, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 28, 2018
7 yr 10 mo ago
Exclusivity ends · ODE-214
Orphan-drug exclusivity (7 years)
Sep 28, 2025
9 mo ago
Today
Patent 8632804 expires
Listed method-of-use patent (U-2416) expiration.
Dec 05, 2026
in 6 mo
Patent 8642075 expires
Listed drug product patent expiration.
Dec 05, 2026
in 6 mo
Patent 8679532 expires
Listed method-of-use patent (U-2415) expiration.
Dec 05, 2026
in 6 mo
Patent 8226975 expires
Listed drug product patent expiration.
Aug 15, 2028
in 2 yr 2 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Sep 28, 2030
in 4 yr 4 mo
Patent 9566234 expires
Listed drug product patent expiration.
Jan 18, 2034
in 7 yr 8 mo
Patent 10251900 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 10751355 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 11446318 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 12016873 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 12168021 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 12168022 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 12377114 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 12616708 expires
Listed method-of-use patent (U-2414) expiration.
May 15, 2035
in 9 yr
Patent 9895385 expires
Listed method-of-use patent (U-2417) expiration.
May 15, 2035
in 9 yr
Pharmaceutical detail
Active ingredient
AMIKACIN SULFATE
Strength
EQ 590MG BASE/8.4ML
Dosage form
SUSPENSION, LIPOSOMAL
Route
INHALATION
TE code
Not listed
Application
NDA 207356
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1987AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 050618 · APOTHECON
- —AMIKINBrand (NDA)
NDA 050495 · APOTHECON
- 2024AMIKACIN SULFATEGeneric (ANDA)
ANDA 218146 · QILU
- 2016AMIKACIN SULFATEGeneric (ANDA)
ANDA 203323 · SAGENT PHARMS INC
- 2015AMIKACIN SULFATEGeneric (ANDA)
ANDA 205605 · FRESENIUS KABI USA
- 2015AMIKACIN SULFATEGeneric (ANDA)
ANDA 205604 · FRESENIUS KABI USA
- 2013AMIKACIN SULFATEGeneric (ANDA)
ANDA 204040 · AVET LIFESCIENCES
- 1997AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 064146 · HOSPIRA
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 063167 · IGI LABS INC
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 063169 · IGI LABS INC
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 064098 · HOSPIRA
- 1995AMIKACIN SULFATEGeneric (ANDA)
ANDA 064099 · HOSPIRA
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)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8632804 | Dec 05, 2026 | in 6 mo | U-2416 |
| 8642075 | Dec 05, 2026 | in 6 mo | Product |
| 8679532 | Dec 05, 2026 | in 6 mo | U-2415 |
| 8226975 | Aug 15, 2028 | in 2 yr 2 mo | Product |
| 9566234 | Jan 18, 2034 | in 7 yr 8 mo | ProductU-2415 |
| 10251900 | May 15, 2035 | in 9 yr | U-2414 |
| 10751355 | May 15, 2035 | in 9 yr | U-2414 |
| 11446318 | May 15, 2035 | in 9 yr | U-2414 |
| 12016873 | May 15, 2035 | in 9 yr | U-2414 |
| 12168021 | May 15, 2035 | in 9 yr | U-2414 |
| 12168022 | May 15, 2035 | in 9 yr | U-2414 |
| 12377114 | May 15, 2035 | in 9 yr | U-2414 |
| 12616708 | May 15, 2035 | in 9 yr | U-2414 |
| 9895385 | May 15, 2035 | in 9 yr | U-2417 |
