Generic Enablex Availability
ENABLEX (darifenacin hydrobromide - tablet, extended release;oral)
Manufacturer: WARNER CHILCOTT LLC
Approval date: December 22, 2004
Strength(s): EQ 7.5MG BASE [AB], EQ 15MG BASE [RLD] [AB]
Has a generic version of Enablex been approved?
A generic version of Enablex 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 Enablex and have been approved by the FDA:
Manufacturer: ANCHEN PHARMS
Approval date: March 13, 2015
Strength(s): EQ 7.5MG BASE [AB], EQ 15MG BASE [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Enablex. 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.
Issued: March 17, 1992
Inventor(s): Cross; Peter E. & MacKenzie; Alexander R.
Assignee(s): Pfizer Inc.
Compounds of the formula ##STR1## wherein R, Y and R.sup.1 are as defined in the specification. These compounds are muscarinic receptor antagonists which are selective for smooth muscle muscarinic sites over cardiac muscarinic sites, and are useful in the treatment of diseases associated with altered motility on tone of smooth muscle, including irritable bowel syndrome, diverticular disease, urinary incontinence, oesophageal achalasia and chronic obstructive airways disease.Patent expiration dates:
- March 13, 2015✓✓✓
- March 13, 2015
Pharmaceutical formulations containing darifenacin
Issued: August 22, 2000
Inventor(s): Dolan; Thomas Francis & Humphrey; Michael John & Nichols; Donald John
Assignee(s): Pfizer Inc.
There is provided a pharmaceutical dosage form adapted for administration to the gastrointestinal tract of a patient, comprising darifenacin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable adjuvant, diluent or carrier, characterized in that the dosage form is adapted to deliver at least 10% by weight of the darifenacin, or the pharmaceutically acceptable salt thereof, to the lower gastrointestinal tract of the patient. The formulation minimizes unwanted side-effects and increases the bioavailability of darifenacin.Patent expiration dates:
- August 21, 2016✓✓
- August 21, 2016
- Enablex Consumer Information (Drugs.com)
- Enablex extended-release tablets Consumer Information (Wolters Kluwer)
- Enablex Consumer Information (Cerner Multum)
- Enablex Advanced Consumer Information (Micromedex®)
- Enablex AHFS DI Monographs (ASHP)
- Darifenacin extended-release tablets Consumer Information (Wolters Kluwer)
- Darifenacin Consumer Information (Cerner Multum)
- Darifenacin Advanced Consumer Information (Micromedex®)
- Darifenacin Hydrobromide 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.|