Generic Nexterone Availability
Last updated on Mar 9, 2023.
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 (discontinued) [RLD]
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?
No. There is currently no therapeutically equivalent version of Nexterone available in the United States.
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: Generic Drug FAQ.
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.
Sulfoalkyl ether cyclodextrin compositions
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✓
- March 13, 2029
More about Nexterone (amiodarone)
- Check interactions
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- Latest FDA alerts (5)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: group III antiarrhythmics
- En español
Pacerone, Cordarone, Cordarone IV
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|Drug Patent||A 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 Exclusivity||Exclusivity 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.|
|RLD||A 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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