Generic Megace ES Availability
See also: Generic Megace
MEGACE ES (megestrol acetate - suspension;oral)
Has a generic version of Megace ES been approved?
A generic version of Megace ES 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 Megace ES and have been approved by the FDA:
Manufacturer: TWI PHARMS INC
Approval date: August 27, 2014
Strength(s): 125MG/ML [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Megace ES. 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.
Nanoparticulate dispersions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
Issued: July 15, 2003
Inventor(s): Niels P.; Ryde & Stephen B.; Ruddy
Assignee(s): Elan Pharma International Ltd.
Disclosed are solid dose nanoparticulate compositions comprising a poorly soluble active agent, at least one polymeric surface stabilizer, and dioctyl sodium sulfosuccinate (DOSS). The solid dose compositions exhibit superior redispersibility of the nanoparticulate composition upon administration to a mammal, such as a human or animal. The invention also describes methods of making and using such compositions.Patent expiration dates:
- September 21, 2020✓
- September 21, 2020
Nanoparticulate megestrol formulations
Issued: September 5, 2006
Inventor(s): Hovey; Douglas & Pruitt; John & Ryde; Tuula
Assignee(s): Elan Pharma International Limited
The present invention is directed to nanoparticulate compositions comprising megestrol. The megestrol particles of the composition have an effective average particle size of less than about 2000 nm.Patent expiration dates:
- April 22, 2024✓
- April 22, 2024
- Megace ES Consumer Information (Drugs.com)
- Megace ES suspension Consumer Information (Wolters Kluwer)
- Megace ES Consumer Information (Cerner Multum)
- Megestrol Consumer Information (Wolters Kluwer)
- Megestrol suspension Consumer Information (Wolters Kluwer)
- Megestrol Consumer Information (Cerner Multum)
- Megestrol Acetate 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.|
|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.|