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  1. pharmadog
  2. ›drugs
  3. ›NILOTINIB HYDROCHLORIDE
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NILOTINIB HYDROCHLORIDE

Marketedupdated 3mo ago
by Hetero Labs Ltd
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • tagApproval6 co-mentions · 3 sources
  • drugNILOTINIB3 co-mentions · 3 sources
  • tagSmall Molecule3 co-mentions · 3 sources
  • companyHetero Labs Ltd1 co-mentions · 1 sources

all catalysts(2)

approval · 2
Nov 19, 2025
approval
9mo ago
NILOTINIB HYDROCHLORIDE — FDA approval
NILOTINIB HYDROCHLORIDE
→
Nov 19, 2025
approval
9mo ago
NILOTINIB HYDROCHLORIDE — FDA approval
NILOTINIB HYDROCHLORIDE
→

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 18, 2027
156 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*PED2.5y
  • Feb 23, 2029patentUS 8163904*PED2.5y
  • Feb 23, 2029patentUS 8163904*PED2.5y
  • Aug 23, 2028compositionUS 81639042.0y
  • Aug 23, 2028compositionUS 81639042.0y
  • Aug 23, 2028compositionUS 81639042.0y
  • Mar 25, 2028patentUS 8293756*PED1.6y
  • Mar 25, 2028patentUS 8293756*PED1.6y
  • Mar 25, 2028patentUS 8293756*PED1.6y
  • Sep 25, 2027formulationUS 82937561.1y
  • Sep 25, 2027formulationUS 82937561.1y
  • Sep 25, 2027formulationUS 82937561.1y
  • Jan 18, 2027patentUS 8389537*PED156d
  • Jan 18, 2027patentUS 8389537*PED156d
  • Jan 18, 2027patentUS 8389537*PED156d
  • Jan 18, 2027patentUS 8415363*PED156d
  • Jan 18, 2027patentUS 8415363*PED156d
  • Jan 18, 2027patentUS 8415363*PED156d
  • Jan 18, 2027patentUS 8501760*PED156d
  • Jan 18, 2027patentUS 8501760*PED156d
  • Jan 18, 2027patentUS 8501760*PED156d
  • 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)2.6y
  • Mar 23, 2029PEDPediatric (6mo bonus)2.6y
  • Mar 23, 2029PEDPediatric (6mo bonus)2.6y
  • Sep 23, 2028ODE-380Orphan Drug (7y)2.1y
  • Sep 23, 2028ODE-380Orphan Drug (7y)2.1y
  • Sep 23, 2028ODE-380Orphan Drug (7y)2.1y

News(0)

no news has mentioned this drug yet

brand
NILOTINIB HYDROCHLORIDE
generic
NILOTINIB HYDROCHLORIDE
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 21m ago
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