Generic Nexterone Availability
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:
Manufacturer: HIKMA FARMACEUTICA
Approval date: February 25, 2008
Strength(s): 50MG/ML [AP]
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.
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
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✓
- May 4, 2022
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
- 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)
|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.|
|AP||Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.|