Report on Veterinary Drug Product – Excenel RTU

Brand Name (generic): Excenel RTU

Generic Name: ceftiofur sodium

DIN: 02239274 - 50 mg/ml

Patentee: Pharmacia Canada Inc.

Indication - as per product monograph: Excenel RTU is indicated for treatment of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae (App) and Pasteurella multocida (Pm).

Notice of Compliance: December 23, 1998

Date of First sale: January 18, 1999

Application of the Guidelines:

Special Provisions for Veterinary Patentees

The Special Provisions for Veterinary Patentees provide for an alternative means to review the price of patented veterinary medicines during the three-year trial complaints-driven process. In lieu of filing price and sales information, patentees must provide the proposed introductory price for any product that was not previously offered for sale in Canada. The Guidelines continue to be applied to the extent that they are appropriate. See PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Special Provisions for Veterinary Patentees.

Scientific Review:

Excenel RTU is a new DIN of an existing medicine in a comparable dosage form.

Excenel Sterile Powder for injection, which contains the sodium salt of ceftiofur (equivalent to ceftiofur 50 mg/mL when reconstituted), was on the market for several years prior to the introduction of Excenel RTU. Excenel Sterile Powder is approved for use in the treatment of susceptible bacterial infections in several species of animals including the treatment of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae (App) and Pasteurella multocida (Pm). Excenel RTU is approved only for swine in Canada although in Europe it is also approved for cattle. The two products are used interchangeably for swine at identical dosage regimens.

Price Review:

Under the Guidelines, the introductory price of a new category 1 drug product will be presumed to be excessive if it does not bear a reasonable relationship (RR) to the average price of other DINs of the same medicine in the same or comparable dosage form, or if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations. Based on the information required to be filed pursuant to the Special Provisions for Veterinary Patentees, the RR test was carried out to review the price of Excenel RTU. The price of Excenel RTU was found to be within the Guidelines as it bears a reasonable relationship to the price of Excenel Sterile Powder.

Note: Prices are based on publicly available prices in the CDMV price list (July-December 1999).