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Generic Onmel Availability

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

ONMEL (itraconazole - tablet;oral)

  • Manufacturer: MERZ PHARMS
    Approval date: April 29, 2010
    Strength(s): 200MG [RLD]

Has a generic version of Onmel been approved?

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

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

  • Antifungal compositions with improved bioavailability
    Patent 6,509,038
    Issued: January 21, 2003
    Inventor(s): Lieven Elvire Colette; Baert & Geert; Verreck & Dany; Thoné
    Assignee(s): Janssen Pharmaceutica N.V.
    The present invention is concerned with novel pharmaceutical compositions of itraconazole which can be administered to a mammal suffering from a fungal infection, whereby a single such dosage form can be administered once daily, and in addition at any time of the day independently of the food taken in by said mammal. These novel compositions comprise particles obtainable by melt-extruding a mixture comprising itraconazole and an appropriate water-soluble polymer and subsequently milling said melt-extruded mixture.
    Patent expiration dates:
    • May 12, 2017
      ✓ 
      Patent use: ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
      ✓ 
      Drug product
  • Antifungal compositions with improved bioavailability
    Patent 7,081,255
    Issued: July 25, 2006
    Inventor(s): Baert; Lieven Elvire Colette & Verreck; Geert & Thoné; Dany
    Assignee(s): Janssen Pharmaceutica, N.V.
    The present invention is concerned with novel pharmaceutical compositions of itraconazole which can be administered to a mammal suffering from a fungal infection, whereby a single such dosage form can be administered once daily, and in addition at any time of the day independently of the food taken in by said mammal. These novel compositions comprise particles obtainable by melt-extruding a mixture comprising itraconazole and an appropriate water-soluble polymer and subsequently milling said melt-extruded mixture.
    Patent expiration dates:
    • May 12, 2017
      ✓ 
      Patent use: ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
      ✓ 
      Drug product
  • Itraconazole compositions with improved bioavailability
    Patent 8,486,456
    Issued: July 16, 2013
    Assignee(s): Abbott GmbH & Co., KG
    A solid dispersion product comprising itraconazole and hydroxypropyl methylcellulose, which satisfies the Formula 0.35>ΔHtr (1) (wherein ΔHtr represents the endotherm (J/g) accompanying a transition at about 240° C). The solid dispersion product shows an improved bioavailability.
    Patent expiration dates:
    • October 3, 2028
      ✓ 
      Patent use: ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
      ✓ 
      Drug product
  • Antifungal compositions with improved bioavailability
    Patent 8,591,948
    Issued: November 26, 2013
    Assignee(s): Janssen Pharmaceutica N.V.
    The present invention is concerned with novel pharmaceutical compositions of itraconazole which can be administered to a mammal suffering from a fungal infection, whereby a single such dosage form can be administered once daily, and in addition at any time of the day independently of the food taken in by said mammal. These novel compositions comprise particles obtainable by melt-extruding a mixture comprising itraconazole and an appropriate water-soluble polymer and subsequently milling said melt-extruded mixture.
    Patent expiration dates:
    • May 12, 2017
      ✓ 
      Patent use: ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
      ✓ 
      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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