drug · small molecule
amikacin sulfate PR
Marketedupdated 3mo agoby $INSM INSMED Inc🔗 ChEMBL
Approvedcommunity read0 votes
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top 4Small molecule drug with a maximum clinical stage of Approval (across all indications), with 8 approved and 3 investigational indications.
targets
Bacterial 70S ribosome
all catalysts(6)
approval · 6
Sep 28, 2018
approval
$INSM125.08-4.27%
ARIKAYCE KIT (AMIKACIN SULFATE) — FDA approval
amikacin sulfate PR
→
Mar 13, 2020
approval
$INSM125.08-4.27%
ARIKAYCE KIT (AMIKACIN SULFATE) — FDA approval
amikacin sulfate PR
→
Oct 19, 2020
approval
$INSM125.08-4.27%
ARIKAYCE KIT (AMIKACIN SULFATE) — FDA approval
amikacin sulfate PR
→
Feb 10, 2023
approval
$INSM125.08-4.27%
ARIKAYCE KIT (AMIKACIN SULFATE) — FDA approval
amikacin sulfate PR
→
Jun 1, 2023
approval
$INSM125.08-4.27%
ARIKAYCE KIT (AMIKACIN SULFATE) — FDA approval
amikacin sulfate PR
→
Dec 5, 2025
approval
$INSM125.08-4.27%
ARIKAYCE KIT (AMIKACIN SULFATE) — FDA approval
amikacin sulfate PR
→
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 5, 2026
106 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (13)
- May 15, 2035method-of-use (U-2414)US 10251900
- May 15, 2035method-of-use (U-2414)US 10751355
- May 15, 2035method-of-use (U-2414)US 11446318
- May 15, 2035method-of-use (U-2414)US 12016873
- May 15, 2035method-of-use (U-2414)US 12168021
- May 15, 2035method-of-use (U-2414)US 12168022
- May 15, 2035method-of-use (U-2414)US 12377114
- May 15, 2035method-of-use (U-2417)US 9895385
- Jan 18, 2034formulationUS 9566234
- Aug 15, 2028formulationUS 82269752.0y
- Dec 5, 2026method-of-use (U-2416)US 8632804106d
- Dec 5, 2026formulationUS 8642075106d
- Dec 5, 2026method-of-use (U-2415)US 8679532106d
FDA exclusivities (2)
- Sep 28, 2030GAINGAIN Antibiotic (5y)4.1y
- Sep 28, 2025ODE-214Orphan Drug (7y)
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