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Generic Enablex Availability

Enablex is a brand name of darifenacin, approved by the FDA in the following formulation(s):

ENABLEX (darifenacin hydrobromide - tablet, extended release;oral)

  • Manufacturer: WARNER CHILCOTT LLC
    Approval date: December 22, 2004
    Strength(s): EQ 7.5MG BASE, EQ 15MG BASE [RLD]

Has a generic version of Enablex been approved?

No. There is currently no therapeutically equivalent version of Enablex available in the United States.

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.

Related Patents

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.

  • Pyrrolidine derivatives
    Patent 5,096,890
    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
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      Patent use: TREATING A DISEASE OF ALTERED MOTILITY OR TONE OF SMOOTH MUSCLE BY ADMINISTERING A MUSCARINIC RECEPTOR ANTAGONIZING AMOUNT OF DARIFENACIN
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      Drug substance
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      Drug product
  • Pharmaceutical formulations containing darifenacin
    Patent 6,106,864
    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
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      Patent use: TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF DARIFENACIN
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      Drug product

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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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