ALOXI

021372 | Orange Book

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Filed July 25, 2003
Type New Drug Application
Case Type New Drug Application
Ingredients PALONOSETRON HYDROCHLORIDE
Dosage Form / Route INJECTABLE and INTRAVENOUS
PatentExpiration
7,947,7241 year, 2 months ago
7,947,7251 year, 2 months ago
7,960,4241 year, 2 months ago
8,518,9811 year, 2 months ago
8,598,2181 year, 2 months ago
8,598,2191 year, 2 months ago
8,729,0941 year, 2 months ago
9,066,9801 year, 2 months ago
9,125,9051 year, 2 months ago
9,173,9421 year, 2 months ago
9,439,8541 year, 2 months ago
9,457,0201 year, 2 months ago
9,457,0211 year, 2 months ago
7,947,7248 months, 1 week ago
7,947,7258 months, 1 week ago
7,960,4248 months, 1 week ago
8,518,9818 months, 1 week ago
8,598,2188 months, 1 week ago
8,598,2198 months, 1 week ago
8,729,0948 months, 1 week ago
9,066,9808 months, 1 week ago
9,125,9058 months, 1 week ago
9,173,9428 months, 1 week ago
9,439,8548 months, 1 week ago
9,457,0208 months, 1 week ago
9,457,0218 months, 1 week ago
+ Show More
Last Updated: 2 years, 7 months ago
Date Patent / Filing No. Patent and Drug Application Information
7/30/20249457021Expiration of Patent No 9,457,021: Has Pediatrict Exclusivity.
7/30/20249457020Expiration of Patent No 9,457,020: Has Pediatrict Exclusivity.
7/30/20249439854Expiration of Patent No 9,439,854: Has Pediatrict Exclusivity.
7/30/20249173942Expiration of Patent No 9,173,942: Has Pediatrict Exclusivity.
7/30/20249125905Expiration of Patent No 9,125,905: Has Pediatrict Exclusivity.
7/30/20249066980Expiration of Patent No 9,066,980: Has Pediatrict Exclusivity.
7/30/20248729094Expiration of Patent No 8,729,094: Has Pediatrict Exclusivity.
7/30/20248598219Expiration of Patent No 8,598,219: Has Pediatrict Exclusivity.
7/30/20248598218Expiration of Patent No 8,598,218: Has Pediatrict Exclusivity.
7/30/20248518981Expiration of Patent No 8,518,981: Has Pediatrict Exclusivity.
7/30/20247960424Expiration of Patent No 7,960,424: Has Pediatrict Exclusivity.
7/30/20247947725Expiration of Patent No 7,947,725: Has Pediatrict Exclusivity.
7/30/20247947724Expiration of Patent No 7,947,724: Has Pediatrict Exclusivity.
1/30/20249457021Expiration of Patent No 9,457,021: (drug product)
1/30/20249457020Expiration of Patent No 9,457,020: (drug product)
1/30/20249439854Expiration of Patent No 9,439,854: (drug product)
1/30/20249173942Expiration of Patent No 9,173,942: (drug product)
1/30/20249125905Expiration of Patent No 9,125,905: (drug product)
1/30/20249066980Expiration of Patent No 9,066,980: (U-528). (drug product)
1/30/20248729094Expiration of Patent No 8,729,094: (U-528). (drug product)
1/30/20248598219Expiration of Patent No 8,598,219: (drug product)
1/30/20248598218Expiration of Patent No 8,598,218: (drug product)
1/30/20248518981Expiration of Patent No 8,518,981: (drug product)
1/30/20247960424Expiration of Patent No 7,960,424: (drug product)
1/30/20247947725Expiration of Patent No 7,947,725: (drug product)
1/30/20247947724Expiration of Patent No 7,947,724: (drug product)
4/1/2020SUPPL-21Labeling-Package Insert:
9/18/2014SUPPL-20Labeling-Package Insert:
5/27/2014SUPPL-19Efficacy-Pediatric:
5/27/2014SUPPL-18Efficacy-Pediatric: Label is not available on this site.
2/6/2014SUPPL-17Labeling-Package Insert:
2/29/2008
Approval for ALOXI, EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
  • Reference Drug
  • Active Ingredient: PALONOSETRON HYDROCHLORIDE
  • Dosage Form: INJECTABLE
  • Dosage Route: INTRAVENOUS
  • Therapeutic Equivalence:
2/29/2008SUPPL-10Efficacy-Labeling Change With Clinical Data:
2/29/2008SUPPL-8Efficacy-New Indication:
8/30/2007SUPPL-6Efficacy-New Dosing Regimen:
8/23/2006SUPPL-5Labeling:
7/5/2005SUPPL-2Labeling:
7/25/2003
Approval for ALOXI, EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
  • Reference Drug
  • Active Ingredient: PALONOSETRON HYDROCHLORIDE
  • Dosage Form: INJECTABLE
  • Dosage Route: INTRAVENOUS
  • Therapeutic Equivalence:
7/25/2003ORIG-1Approval: