Nexterone

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

NEXTERONE (amiodarone hydrochloride - injectable; injection)

• 
  Manufacturer: BAXTER HLTHCARE
  
  Approval date: December 24, 2008
  
  Strength(s): 50MG/ML ^[AP]


• 
  Manufacturer: BAXTER HLTHCARE
  
  Approval date: November 16, 2010
  
  Strength(s): 150MG/100ML (1.5MG/ML) ^[RLD], 360MG/200ML (1.8MG/ML) ^[RLD]

Has a generic version of Nexterone been approved?

A generic version of Nexterone has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Nexterone and have been approved by the FDA:

amiodarone hydrochloride injectable; injection

• 
  Manufacturer: HIKMA FARMACEUTICA
  
  Approval date: February 25, 2008
  
  Strength(s): 50MG/ML ^[AP]


• 
  Manufacturer: WOCKHARDT
  
  Approval date: October 30, 2008
  
  Strength(s): 50MG/ML ^[AP], 50MG/ML ^[AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nexterone. 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.

• 
  Formulations containing amiodarone and sulfoalkyl ether cyclodextrin
  Patent 6,869,939
  Issued: March 22, 2005
  Inventor(s): Mosher; Gerold L. & Johnson; Karen T. & Gayed; Atef A.
  Assignee(s): CyDex, Inc.
  The present invention provides aqueous parenteral formulations containing an antiarrhythmic agent, such as amiodarone, and a sulfoalkyl ether cyclodextrin. The liquid formulations are clear, sterilizable, and chemically and physically stable. The liquid formulations do not require a surfactant and do not precipitate upon dilution with distilled water or other pharmaceutically acceptable liquid carrier. The sulfoalkyl ether cyclodextrin-containing formulation provides significant advantages over other cyclodextrin-containing formulations of amiodarone. The formulation can be prepared in acidic, neutral and slightly basic medium while providing acceptable concentrations of amiodarone suitable for parenteral administration. An SAE-CD-containing formulation of amiodarone can be provided in liquid form or as a reconstitutable powder. Moreover, highly concentrated solutions exceeding 200 mg of amiodarone per mL can be prepared. Solutions can be made either dilutable or non-dilutable with water at room temperature or under conditions typically encountered in the clinic.
  
  Patent expiration dates:
  
  
  • May 4, 2022
    
    ✓ 
    Drug product
  
  



• 
  Sulfoalkyl ether cyclodextrin compositions
  Patent 7,635,773
  Issued: December 22, 2009
  Inventor(s): Antle; Vincent
  Assignee(s): CyDex Pharmaceuticals, Inc.
  SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD composition comprises a sulfoalkyl ether cyclodextrin and less than 100 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
  
  Patent expiration dates:
  
  
  • March 13, 2029
    
    ✓ 
    Drug product
  
  

See also...

• Nexterone Consumer Information (Drugs.com)
• Nexterone Solution Consumer Information (Wolters Kluwer)
• Nexterone injection Consumer Information (Cerner Multum)
• Amiodarone Consumer Information (Drugs.com)
• Amiodarone Consumer Information (Wolters Kluwer)
• Amiodarone Solution Consumer Information (Wolters Kluwer)
• Amiodarone Consumer Information (Cerner Multum)
• Amiodarone injection Consumer Information (Cerner Multum)
• Amiodarone Intravenous Advanced Consumer Information (Micromedex)
• Amiodarone Intravenous, Oral Advanced Consumer Information (Micromedex)
• Amiodarone Hydrochloride AHFS DI Monographs (ASHP)