Generic Vivelle-Dot Availability
See also: Generic Vivelle
VIVELLE-DOT (estradiol - film, extended release;transdermal)
Approval date: January 8, 1999
Strength(s): 0.0375MG/24HR [AB1], 0.05MG/24HR [AB1], 0.075MG/24HR [AB1], 0.1MG/24HR [RLD] [AB1]
Approval date: May 3, 2002
Strength(s): 0.025MG/24HR [AB1]
Has a generic version of Vivelle-Dot been approved?
A generic version of Vivelle-Dot 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 Vivelle-Dot and have been approved by the FDA:
Manufacturer: MYLAN TECHNOLOGIES
Approval date: December 19, 2014
Strength(s): 0.025MG/24HR [AB1], 0.0375MG/24HR [AB1], 0.05MG/24HR [AB1], 0.075MG/24HR [AB1], 0.1MG/24HR [AB1]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vivelle-Dot. 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.
Solubility parameter based drug delivery system and method for altering drug saturation concentration
Issued: August 12, 1997
Inventor(s): Miranda; Jesus & Sablotsky; Steven
Assignee(s): Noven Pharmaceuticals, Inc.
A blend of at least two polymers, or at least one polymer and a soluble polyvinylpyrrolidone, in combination with a drug provides a pressure-sensitive adhesive composition for a transdermal drug delivery system in which the drug is delivered from the pressure-sensitive adhesive composition and through dermis when the pressure-sensitive adhesive composition is in contact with human skin. According to the invention, soluble polyvinylpyrrolidone can be used to prevent crystallization of the drug, without affecting the rate of drug delivery from the pressure-sensitive adhesive composition.Patent expiration dates:
- August 12, 2014✓
- August 12, 2014
- August 12, 2014
More about Vivelle-Dot (estradiol)
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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.|
|AB||Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.|