drug
selumetinib sulfate
Marketedupdated 5mo agoby AstraZeneca Pharmaceuticals LP
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for neurofibromatosis type 1 and neoplasm and 20 investigational indications.
all catalysts(7)
approval · 7
Apr 10, 2020
approval
$AZN166.15-0.26%
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Dec 22, 2021
approval
$AZN166.15-0.26%
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Jan 24, 2024
approval
$AZN166.15-0.26%
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Sep 10, 2025
approval
$AZN166.15-0.26%
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Sep 10, 2025
approval
$AZN166.15-0.26%
KOSELUGO (SELUMETINIB) — FDA approval
selumetinib sulfate
→
Nov 19, 2025
approval
$AZN166.15-0.26%
KOSELUGO (SELUMETINIB SULFATE) — FDA approval
selumetinib sulfate
→
Nov 19, 2025
approval
$AZN166.15-0.26%
KOSELUGO (SELUMETINIB) — FDA approval
selumetinib sulfate
→
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 12, 2026
73 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (24)
- Mar 26, 2029formulationUS 118132462.5y
- Mar 26, 2029formulationUS 118132462.5y
- Mar 26, 2029formulationUS 122204032.5y
- Mar 26, 2029formulationUS 122204032.5y
- Mar 26, 2029formulationUS 123183672.5y
- Mar 26, 2029formulationUS 123183672.5y
- Mar 26, 2029method-of-use (U-4357)US 123646842.5y
- Mar 26, 2029method-of-use (U-4357)US 123646842.5y
- Mar 13, 2028compositionUS 74256371.5y
- Mar 13, 2028compositionUS 74256371.5y
- Mar 13, 2028compositionUS 74256371.5y
- Mar 13, 2028compositionUS 74256371.5y
- Dec 12, 2026compositionUS 915679573d
- Dec 12, 2026compositionUS 915679573d
- Dec 12, 2026compositionUS 915679573d
- Dec 12, 2026compositionUS 915679573d
- Dec 12, 2026compositionUS 956201773d
- Dec 12, 2026compositionUS 956201773d
- Dec 12, 2026compositionUS 956201773d
- Dec 12, 2026compositionUS 956201773d
- Mar 13, 2026compositionUS 8178693
- Mar 13, 2026compositionUS 8178693
- Mar 13, 2026compositionUS 8178693
- Mar 13, 2026compositionUS 8178693
FDA exclusivities (12)
- Nov 19, 2028NPPNew Product (3y)2.1y
- Nov 19, 2028NPPNew Product (3y)2.1y
- Nov 19, 2028NPPNew Product (3y)2.1y
- Nov 19, 2028NPPNew Product (3y)2.1y
- Sep 10, 2028NPPNew Product (3y)1.9y
- Sep 10, 2028NPPNew Product (3y)1.9y
- Sep 10, 2028NPNP1.9y
- Sep 10, 2028NPNP1.9y
- Apr 10, 2027ODE*ODE*192d
- Apr 10, 2027ODE*ODE*192d
- Apr 10, 2027ODE-288Orphan Drug (7y)192d
- Apr 10, 2027ODE-288Orphan Drug (7y)192d
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