Impax Labs to market generic or authorized generic version of OxyContin under deal with Purdue Pharma
HAYWARD, Calif. — Impax Labs has settled a patent-infringement suit filed by Purdue Pharma concerning the opioid painkiller OxyContin, Impax said Tuesday.
The generic drug maker said that under the agreement, it will have the right to market a certain quantity of generic oxycodone extended-release tablets upon receiving Food and Drug Administration approval. If it does not receive FDA approval, it will be allowed to market an authorized generic version of the drug starting in January 2016. An authorized generic drug is a branded drug marketed at a discounted price under its generic name, usually under a contract between the branded drug’s manufacturer and a third-party company.
OxyContin is used for long-term treatment of moderate to severe pain over an extended period of time. The drug had sales of about $2.6 billion during the 12-month period that ended in September, according to IMS Health.
Roxane Labs’ generic prostate drug gets tentative approval from FDA
SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.
The FDA granted tentative approval to Roxane Labs’ dutasteride capsules in the 0.5-mg strength. The drug is a generic version of GSK’s Avodart, used to treat benign prostatic hyperplasia.
Tentative approval means that a drug meets the agency’s conditions for approval, but can’t receive final approval until Avodart loses its patent protection, which will occur in 2015.
FDA gives tentative approval to Roxane pneumonia drug
SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.
According to the FDA’s website, the agency granted the preliminary authorization for Roxane Labs’ linezolid oral suspension in the 100-mg-per-5-mL strength.
The drug is a generic version of Pfizer’s Zyvox. Tentative approval means that the product meets the FDA’s requirements for approval, but the agency can’t approve it until patents covering the branded version expire; the first patent on the drug will expire in 2014.