Generic Spectracef Availability

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

SPECTRACEF (cefditoren pivoxil - tablet;oral)

  • Manufacturer: VANSEN PHARMA
    Approval date: August 29, 2001
    Strength(s): 200MG
  • Manufacturer: VANSEN PHARMA
    Approval date: July 21, 2008
    Strength(s): 400MG [RLD]

Has a generic version of Spectracef been approved?

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

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

  • Antibacterial composition for oral administration
    Patent 5,958,915
    Issued: September 28, 1999
    Inventor(s): Abe; Kenichi & Ota; Masato & Yamaguchi; Hiroyuki & Murakami; Chikako & Kikkoji; Toshihiro
    Assignee(s): Meiji Seika Kaisha, Ltd.
    A new, antibacterial composition for use in oral administration is now provided, which composition comprises a mixture of Cefditoren pivoxyl with a water soluble casein salt. This composition has a reduced bitter taste of Cefditoren pivoxyl and also has improved properties regarding the rate and concentration of dissolution of Cefditoren pivoxyl in water and a ratio of dissolution out of Cefditoren pivoxyl into water. This composition further can attain a high absorbability of the Cefditoren component at the digestive tubes upon oral administration thereof. In this composition, the ratio (by weight) of Cefditoren pivoxyl to the casein salt added may preferably be in a range of 1:0.1 to 1:4. By further addition of a water-soluble polyphosphoric acid salt to the composition, the composition can prevent a ratio of dissolution out into water of the Cefditoren pivoxyl component being decreased when the composition was stored under severe conditions.
    Patent expiration dates:
    • October 14, 2016
      ✓ 
      Drug product
    • October 14, 2016

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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