Generic Aloxi Availability

Aloxi is a brand name of palonosetron, approved by the FDA in the following formulation(s):

ALOXI (palonosetron hydrochloride - injectable;intravenous)

  • Manufacturer: HELSINN HLTHCARE
    Approval date: July 25, 2003
    Strength(s): EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) [RLD]
  • Manufacturer: HELSINN HLTHCARE
    Approval date: February 29, 2008
    Strength(s): EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) [RLD]

Has a generic version of Aloxi been approved?

No. There is currently no therapeutically equivalent version of Aloxi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Aloxi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Tricyclic 5-HT.sub.3 receptor antagonists
    Patent 5,202,333
    Issued: April 13, 1993
    Inventor(s): Berger; Jacob & Clark; Robin D. & Eglen; Richard M. & Smith; William L. & Weinhardt; Klaus K.
    Assignee(s): Syntex (U.S.A.) Inc.
    The present invention is directed to 5-HT.sub.3 receptor antagonist compounds of formula I: ##STR1## in which the dashed line denotes an optional double bond; n is 1, 2 or 3; p is 0, 1, 2 or 3; q is 0, 1 or 2; each R.sup.1 is independently selected from halogen, hydroxy, lower alkoxy, lower alkyl, nitro, amino, amino carbonyl, (lower alkyl)amino, di(lower alkyl)amino, and (lower alkanoyl)amino; each R.sup.2 is lower alkyl; and R.sup.3 is a group selected from Formulae (a), (b), (c) and (d): ##STR2## in which u is 0 or 1; z is 1, 2 or 3; and R.sup.4 is C.sub.1-7 alkyl, C.sub.3-8 cycloalkyl, C.sub.3-8 cycloalkyl-C.sub.1-2 alkyl, or a group (CH.sub.2).sub.t R.sup.5 where t is 1 or 2 and R.sup.5 is thienyl, pyrrolyl, or furyl, each optionally further substituted by one or two substituents selected from C.sub.1-6 alkyl, C.sub.1-6 alkoxy, trifluoromethyl or halogen, or is phenyl optionally substituted by one or two substituents selected from C.sub.1-4 alkoxy, trifluoromethyl, halogen, nitro, carboxy, esterified carboxy, and C.sub.1-4 alkyl optionally substituted by hydroxy, C.sub.1-4 alkoxy, carboxy, esterified carboxy or in vivo hydrolyzable acyloxy; and the pharmaceutically acceptable salts, individual isomers, mixtures of isomers, processes for preparation, compositions, and methods of use thereof.
    Patent expiration dates:
    • April 13, 2015
      ✓ 
      Patent use: PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 13, 2015
      ✓ 
      Patent use: PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 13, 2015
      ✓ 
      Pediatric exclusivity
  • Liquid pharmaceutical formulations of palonosetron
    Patent 7,947,724
    Issued: May 24, 2011
    Inventor(s): Calderari; Giorgio & Bonadeo; Daniele & Cannella; Roberta & Braglia; Enrico & Braglia; Riccardo & Miksztal; Andrew & Malefyt; Thomas & Lee; Kathleen M.
    Assignee(s): Helsinn Healthcare S.A. Roche Palo Alto LLC
    The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
    Patent expiration dates:
    • January 30, 2024
      ✓ 
      Drug product
    • July 30, 2024
      ✓ 
      Pediatric exclusivity
  • Liquid pharmaceutical formulations of palonosetron
    Patent 7,947,725
    Issued: May 24, 2011
    Inventor(s): Calderari; Giorgio & Bonadeo; Daniele & Cannella; Roberta & Braglia; Enrico & Braglia; Riccardo & Miksztal; Andrew & Malefyt; Thomas & Lee; Kathleen M.
    Assignee(s): Helsinn Healthcare S.A. Roche Palo Alto LLC
    The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
    Patent expiration dates:
    • January 30, 2024
      ✓ 
      Drug product
    • July 30, 2024
      ✓ 
      Pediatric exclusivity
  • Liquid pharmaceutical formulations of palonosetron
    Patent 7,960,424
    Issued: June 14, 2011
    Inventor(s): Calderari; Giorgio & Bonadeo; Daniele & Cannella; Roberta & Braglia; Enrico & Braglia; Riccardo & Miksztal; Andrew & Malefyt; Thomas & Lee; Kathleen M.
    Assignee(s): Helsinn Healthcare S.A. Roche Palo Alto LLC
    The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
    Patent expiration dates:
    • January 30, 2024
      ✓ 
      Drug product
    • July 30, 2024
      ✓ 
      Pediatric exclusivity
  • Liquid pharmaceutical formulations of palonosetron
    Patent 8,518,981
    Issued: August 27, 2013
    Assignee(s): Helsinn Healthcare SA Roche Palo Alto LLC
    The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
    Patent expiration dates:
    • January 30, 2024
      ✓ 
      Drug product
    • July 30, 2024
      ✓ 
      Pediatric exclusivity
  • Liquid pharmaceutical formulations of palonosetron
    Patent 8,598,218
    Issued: December 3, 2013
    Assignee(s): Helsinn Healthcare SA Roche Palo Alto LLC
    The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
    Patent expiration dates:
    • January 30, 2024
      ✓ 
      Drug product
    • July 30, 2024
      ✓ 
      Pediatric exclusivity
  • Liquid pharmaceutical formulations of palonosetron
    Patent 8,598,219
    Issued: December 3, 2013
    Assignee(s): Helsinn Healthcare SA Roche Palo Alto LLC
    The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
    Patent expiration dates:
    • January 30, 2024
      ✓ 
      Drug product
    • July 30, 2024
      ✓ 
      Pediatric exclusivity
  • Liquid pharmaceutical formulations of palonosetron
    Patent 8,729,094
    Issued: May 20, 2014
    Assignee(s): Helsinn Healthcare SA Roche Palo Alto LLC
    The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
    Patent expiration dates:
    • January 30, 2024
      ✓ 
      Patent use: PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
      ✓ 
      Drug product
    • July 30, 2024
      ✓ 
      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • May 27, 2017 - PREVENTION OF ACUTE NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF EMETOGENIC CANCER CHEMOTHERAPY, INCLUDING HIGHLY EMETOGENIC CANCER CHEMOTHERAPY IN PEDIATRIC PATIENTS AGED 1 MONTH TO LESS THAN 17 YEARS
    • May 27, 2017 - ADDITIONAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING REGARDING POST-OPERATIVE NAUSEA AND VOMITING STUDIES IN PEDIATRIC PATIENTS
    • November 27, 2017 -

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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