Report on Veterinary Drug Product - Orbax

Brand Name: Orbax

Generic Name: orbifloxacin

DIN: 02237712 – 5.7 mg/tablet, 02237713 – 22.7 mg/tablet, 02237714 – 68 mg/tablet

Patentee: Schering Canada Inc.

Indication - as per product monograph: Orbax is a synthetic broad spectrum antibiotic belonging to the class of fluoroquinilone carboxylic acid derivatives; it is used to treat urinary tract infections (UTI) in dogs and skin and soft tissue infections in dogs and cats.

Notice of Compliance: April 6, 1998

Date of First sale: February 23, 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 the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Special Provisions for Veterinary Patentees.

Scientific Review:

Many antibiotics are used for treating UTI in dogs and wounds and abscesses in dogs and cats, including single entity products of the penicillin, cephalosporin, aminoglycoside, and fluoroquinilone antibiotic groups as well as combination antibiotic drug products such as amoxicillin-clavulanic acid and trimethoprim-sulfamethoxazole. Clinicians' choices of antibiotic product, dosage and treatment duration vary considerably.

The comparators selected for the TCC are those that appear to be most commonly used and have been approved by Health Canada for veterinary use in this indication. Baytril (endrofloxacin, Bayer) is the closest comparator as it is also a fluoroquinilone antibiotic. Clinicians generally tend to reserve the fluoroquinilone antibiotics for the more difficult to treat infections.

In establishing comparable dosage regimens for the TCC, the dosage regimens for dogs and the maximum duration of treatment were used for each product. The recommended dosage for dogs and cats is 2.5 mg/kg body weight once daily. The recommended duration of treatment ranges from 5 to 10 days for skin infections and 10 days for UTI in dogs.

Price Review:

Under the Guidelines, the introductory price of a new category 3 drug product will be presumed to be excessive if it exceeds the price of all the comparable drug products in the TCC test, or if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicine Regulations. Based on the information required to be filed pursuant to the Special Provisions for Veterinary Patentees, the TCC test was carried out to review the price of Orbax. The price of Orbax was within the Guidelines as it did not exceed the prices of all drugs in the TCC.

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