drug
NILOTINIB HYDROCHLORIDE
Marketedupdated 5mo agoby Hetero Labs Ltd
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4all catalysts(2)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 18, 2027
104 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (36)
- Oct 7, 2032patentUS 9061029*PED
- Oct 7, 2032patentUS 9061029*PED
- Oct 7, 2032patentUS 9061029*PED
- Apr 7, 2032compositionUS 9061029
- Apr 7, 2032compositionUS 9061029
- Apr 7, 2032compositionUS 9061029
- Feb 23, 2029patentUS 8163904*PED2.4y
- Feb 23, 2029patentUS 8163904*PED2.4y
- Feb 23, 2029patentUS 8163904*PED2.4y
- Aug 23, 2028compositionUS 81639041.9y
- Aug 23, 2028compositionUS 81639041.9y
- Aug 23, 2028compositionUS 81639041.9y
- Mar 25, 2028patentUS 8293756*PED1.5y
- Mar 25, 2028patentUS 8293756*PED1.5y
- Mar 25, 2028patentUS 8293756*PED1.5y
- Sep 25, 2027formulationUS 8293756354d
- Sep 25, 2027formulationUS 8293756354d
- Sep 25, 2027formulationUS 8293756354d
- Jan 18, 2027patentUS 8389537*PED104d
- Jan 18, 2027patentUS 8389537*PED104d
- Jan 18, 2027patentUS 8389537*PED104d
- Jan 18, 2027patentUS 8415363*PED104d
- Jan 18, 2027patentUS 8415363*PED104d
- Jan 18, 2027patentUS 8415363*PED104d
- Jan 18, 2027patentUS 8501760*PED104d
- Jan 18, 2027patentUS 8501760*PED104d
- Jan 18, 2027patentUS 8501760*PED104d
- Jul 18, 2026method-of-use (U-1374)US 8389537
- Jul 18, 2026method-of-use (U-1374)US 8389537
- Jul 18, 2026method-of-use (U-1374)US 8389537
- Jul 18, 2026compositionUS 8415363
- Jul 18, 2026compositionUS 8415363
- Jul 18, 2026compositionUS 8415363
- Jul 18, 2026formulationUS 8501760
- Jul 18, 2026formulationUS 8501760
- Jul 18, 2026formulationUS 8501760
FDA exclusivities (6)
- Mar 23, 2029PEDPediatric (6mo bonus)2.5y
- Mar 23, 2029PEDPediatric (6mo bonus)2.5y
- Mar 23, 2029PEDPediatric (6mo bonus)2.5y
- Sep 23, 2028ODE-380Orphan Drug (7y)2.0y
- Sep 23, 2028ODE-380Orphan Drug (7y)2.0y
- Sep 23, 2028ODE-380Orphan Drug (7y)2.0y
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