Generic Entocort EC Availability

Entocort EC is a brand name of budesonide, approved by the FDA in the following formulation(s):

ENTOCORT EC (budesonide - capsule;oral)

  • Manufacturer: ASTRAZENECA
    Approval date: October 2, 2001
    Strength(s): 3MG [RLD] [AB]

Has a generic version of Entocort EC been approved?

A generic version of Entocort EC 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 Entocort EC and have been approved by the FDA:

budesonide capsule;oral

  • Manufacturer: BARR LABS DIV TEVA
    Approval date: April 2, 2014
    Strength(s): 3MG [AB]
  • Manufacturer: MYLAN
    Approval date: May 16, 2011
    Strength(s): 3MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Entocort EC. 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.

  • Oral composition for the treatment of inflammatory bowel disease
    Patent 5,643,602
    Issued: July 1, 1997
    Inventor(s): Ulmius; Jan
    Assignee(s): Astra Aktiebolag
    An oral pharmaceutical composition is described for targeted slow release in the treatment of inflammatory bowel diseases. Also described are pharmaceutical compositions for peroral treatment targeted to different areas of the intestinal tract afflicted by ulcerative colitis and certain aspects of Crohn's disease.
    Patent expiration dates:
    • July 1, 2014
      ✓ 
      Patent use: TREATMENT OF MILD TO MODERATE ACTIVE CHROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON AND THE MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR ASCENDING COLON FOR UP TO 3 MONTHS
    • January 1, 2015
      ✓ 
      Pediatric exclusivity

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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