Generic Ditropan XL Availability

Ditropan XL is a brand name of oxybutynin, approved by the FDA in the following formulation(s):

DITROPAN XL (oxybutynin chloride - tablet, extended release; oral)

Has a generic version of Ditropan XL been approved?

A generic version of Ditropan XL 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 Ditropan XL and have been approved by the FDA:

oxybutynin chloride tablet, extended release; oral

  • Manufacturer: IMPAX PHARMS
    Approval date: November 9, 2006
    Strength(s): 15MG [AB]
  • Manufacturer: IMPAX PHARMS
    Approval date: May 9, 2007
    Strength(s): 10MG [AB], 5MG [AB]
  • Manufacturer: MYLAN
    Approval date: November 9, 2006
    Strength(s): 5MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: November 9, 2006
    Strength(s): 10MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: May 10, 2007
    Strength(s): 15MG [AB]
  • Manufacturer: OSMOTICA PHARM
    Approval date: February 4, 2009
    Strength(s): 10MG [AB], 15MG [AB], 5MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ditropan XL. 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.

  • Dosage form comprising oxybutynin
    Patent 5,674,895
    Issued: October 7, 1997
    Inventor(s): Guittard; George V. & Jao; Francisco & Marks; Susan M. & Kidney; David J. & Gumucio; Fernando
    Assignee(s): Alza Corporation
    A composition comprising oxybutynin and a device comprising oxybutynin are disclosed for oxybutynin therapy.
    Patent expiration dates:
    • May 22, 2015
    • November 22, 2015
      ✓ 
      Pediatric exclusivity
  • Dosage form comprising oxybutynin
    Patent 5,840,754
    Issued: November 24, 1998
    Inventor(s): Guittard; George V. & Jao; Francisco & Marks; Susan M. & Kidney; David J. & Gumucio; Fernando
    Assignee(s): ALZA Corporation
    A composition comprising oxybutynin, a device comprising oxybutynin, and a method for administering oxybutynin are disclosed for oxybutynin therapy.
    Patent expiration dates:
    • May 22, 2015
    • November 22, 2015
      ✓ 
      Pediatric exclusivity
  • Dosage form and method for treating incontinence
    Patent 5,912,268
    Issued: June 15, 1999
    Inventor(s): Guittard; George V. & Jao; Francisco & Marks; Susan M. & Kidney; David J. & Gumucio; Fernando E.
    Assignee(s): Alza Corporation
    A composition comprising oxybutynin, a device comprising oxybutynin, and a method for administering oxybutynin are disclosed for oxybutynin therapy.
    Patent expiration dates:
    • May 22, 2015
    • November 22, 2015
      ✓ 
      Pediatric exclusivity
  • Method for the management of incontinence
    Patent 6,262,115
    Issued: July 17, 2001
    Inventor(s): Guittard; George V. & Jao; Francisco & Marks; Susan M. & Kidney; David J. & Gumucio; Fernando E.
    Assignee(s): ALZA Coporation
    A composition and a dosage form are disclosed comprising oxybutynin alone/or accompanied by another drug indicated for therapy. A method is disclosed for administering oxybutynin alone/or accompanied by a different drug or for administering oxybutynin and a different drug according to a therapeutic program for the management of incontinence alone, and for other therapy.
    Patent expiration dates:
    • May 22, 2015
      ✓ 
      Patent use: MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF INVOLUNTARY INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH PT
    • November 22, 2015
      ✓ 
      Patent use: MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF INVOLUNTARY INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH PT
      ✓ 
      Pediatric exclusivity

See also...

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.
ABProducts 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.
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