Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (22)

Sep 30, 2033formulationUS 9675549
Sep 30, 2033formulationUS 9675549
Feb 26, 2031method-of-use (U-3661)US 83576904.4y
Feb 26, 2031method-of-use (U-3661)US 83576904.4y
May 14, 2030method-of-use (U-3661)US 95550403.6y
May 14, 2030method-of-use (U-3661)US 95550403.6y
Mar 23, 2030method-of-use (U-3661)US 88362183.5y
Mar 23, 2030method-of-use (U-3661)US 88362183.5y
Aug 15, 2029formulationUS 79685432.9y
Aug 15, 2029formulationUS 79685432.9y
Aug 15, 2029formulationUS 88657102.9y
Aug 15, 2029formulationUS 88657102.9y
Sep 26, 2028compositionUS 78206572.0y
Sep 26, 2028compositionUS 78206572.0y
Mar 16, 2027method-of-use (U-3661)US 8129374167d
Mar 16, 2027method-of-use (U-3661)US 8129374167d
Mar 16, 2027formulationUS 8557810167d
Mar 16, 2027formulationUS 8557810167d
Mar 16, 2027compositionUS 8883783167d
Mar 16, 2027compositionUS 8883783167d
Mar 16, 2027method-of-use (U-3661)US 9585892167d
Mar 16, 2027method-of-use (U-3661)US 9585892167d

FDA exclusivities (4)

Jul 20, 2030ODE-437Orphan Drug (7y)3.8y
Jul 20, 2030ODE-437Orphan Drug (7y)3.8y
Jul 20, 2028NCENew Chemical Entity (5y)1.8y
Jul 20, 2028NCENew Chemical Entity (5y)1.8y

News(0)

no news has mentioned this drug yet

Data sources

openFDA · ClinicalTrials.gov

last refreshed 2h ago

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quizartinib dihydrochloride

Marketedupdated 5mo ago

by Daiichi Sankyo Co Ltd

Approved

community read0 votes

🐶 often sniffed alongside

top 3

all catalysts(3)

approval · 3

Jul 20, 2023

approval

3y ago

VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approval

quizartinib dihydrochloride

VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approval

quizartinib dihydrochloride

VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approval

quizartinib dihydrochloride

→

Patent cliff

source: FDA Orange Book

first barrier falls

Mar 16, 2027

167 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (22)

Sep 30, 2033formulationUS 9675549
Sep 30, 2033formulationUS 9675549
Feb 26, 2031method-of-use (U-3661)US 83576904.4y
Feb 26, 2031method-of-use (U-3661)US 83576904.4y
May 14, 2030method-of-use (U-3661)US 95550403.6y
May 14, 2030method-of-use (U-3661)US 95550403.6y
Mar 23, 2030method-of-use (U-3661)US 88362183.5y
Mar 23, 2030method-of-use (U-3661)US 88362183.5y
Aug 15, 2029formulationUS 79685432.9y
Aug 15, 2029formulationUS 79685432.9y
Aug 15, 2029formulationUS 88657102.9y
Aug 15, 2029formulationUS 88657102.9y
Sep 26, 2028compositionUS 78206572.0y
Sep 26, 2028compositionUS 78206572.0y
Mar 16, 2027method-of-use (U-3661)US 8129374167d
Mar 16, 2027method-of-use (U-3661)US 8129374167d
Mar 16, 2027formulationUS 8557810167d
Mar 16, 2027formulationUS 8557810167d
Mar 16, 2027compositionUS 8883783167d
Mar 16, 2027compositionUS 8883783167d
Mar 16, 2027method-of-use (U-3661)US 9585892167d
Mar 16, 2027method-of-use (U-3661)US 9585892167d

FDA exclusivities (4)

Jul 20, 2030ODE-437Orphan Drug (7y)3.8y
Jul 20, 2030ODE-437Orphan Drug (7y)3.8y
Jul 20, 2028NCENew Chemical Entity (5y)1.8y
Jul 20, 2028NCENew Chemical Entity (5y)1.8y

News(0)

no news has mentioned this drug yet

Data sources

openFDA · ClinicalTrials.gov

last refreshed 2h ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

quizartinib dihydrochloride

🐶 often sniffed alongside

all catalysts(3)

Patent cliff

patents (22)

FDA exclusivities (4)

News(0)

Report a data issue

comments(0)

quizartinib dihydrochloride

🐶 often sniffed alongside

all catalysts(3)

Patent cliff

patents (22)

FDA exclusivities (4)

News(0)

Report a data issue

comments(0)