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Generic Vicoprofen Availability

Vicoprofen is a brand name of hydrocodone/ibuprofen, approved by the FDA in the following formulation(s):

VICOPROFEN (hydrocodone bitartrate; ibuprofen - tablet;oral)

  • Manufacturer: ABBVIE
    Approval date: September 23, 1997
    Strength(s): 7.5MG;200MG [RLD] [AB]

Has a generic version of Vicoprofen been approved?

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

HYDROCODONE BITARTRATE AND IBUPROFEN (hydrocodone bitartrate; ibuprofen tablet;oral)

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: December 31, 2003
    Strength(s): 7.5MG;200MG [AB]
  • Manufacturer: AMNEAL PHARMS NY
    Approval date: October 12, 2004
    Strength(s): 7.5MG;200MG [AB]
  • Manufacturer: AUROLIFE PHARMA LLC
    Approval date: June 2, 2016
    Strength(s): 7.5MG;200MG [AB]
  • Manufacturer: SUN PHARM INDS INC
    Approval date: May 28, 2013
    Strength(s): 7.5MG;200MG [AB]
  • Manufacturer: TEVA
    Approval date: April 11, 2003
    Strength(s): 7.5MG;200MG [AB]
  • Manufacturer: VINTAGE PHARMS
    Approval date: November 6, 2006
    Strength(s): 7.5MG;200MG [AB]

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

  • Ibuprofen and narcotic analgesic compositions
    Patent 6,348,216
    Issued: February 19, 2002
    Inventor(s): Gregory P.; Kushla & Jin-Wang; Lai & Gerald P.; Polli
    Assignee(s): Knoll Pharmaceutical Company
    Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant. Also provided herein is a method of preparing a pharmaceutical tablet composition comprising: (a) Granulating ibuprofen, a narcotic analgesic, a first glidant, a first disintegrant, a binder, and starch to form granules wherein said granulating step comprises a wet granulation process; (b) blending the granules with extra-granular material comprised of a second glidant, a second disintegrant, a filler and starch to form a blend of granules and extra-granular material; and (c) compressing the blend into a tablet.
    Patent expiration dates:
    • June 10, 2017
  • Method of making ibuprofen and narcotic analgesic compositions
    Patent 6,599,531
    Issued: July 29, 2003
    Inventor(s): Gregory P.; Kushla & Jin-Wang; Lai & Gerald P.; Polli
    Assignee(s): Knoll Pharmaceutical Company
    Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant. Also provided herein is a method of preparing a pharmaceutical tablet composition comprising: (a) Granulating ibuprofen, a narcotic analgesic, a first glidant, a first disintegrant, a binder, and starch to form granules wherein said granulating step comprises a wet granulation process; (b) blending the granules with extra-granular material comprised of a second glidant, a second disintegrant, a filler and starch to form a blend of granules and extra-granular material; and (c) compressing the blend into a tablet.
    Patent expiration dates:
    • June 10, 2017

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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