News today that Dr. Reddy’s subsidiary Promius Pharma has gained tentative approval for their 40mg formulation of doxycycline for the papules and pustles of rosacea.
Before we get too excited about the real possibility of the availability of a generic form of Oracea, the announcement tells us that the approval is “subject to an automatic stay of final approval for up to 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act (“Hatch Waxman”).”
Indeed we know that Galderma will vigorously defend the patents that cover Oracea.
Companies like Promius exist to make money on generic alternatives of prescription treatments, but one has to wonder how much time, effort and money is required to be able to market a product against industry heavyweights like Galderma.
February 01, 2016 02:33 AM Eastern Standard Time
HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)
Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announced today the U.S. Food and Drug Administration (US FDA) tentative approval for Zenavod (doxycycline) Capsules, 40 mg.
Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Promius Pharma, LLC, the U.S. subsidiary of India’s Dr. Reddy’s Laboratories will be responsible for commercializing Zenavod in the U.S. market.
Promius Pharma is probably best know to rosacea sufferers via the availability of Promiseb Topical Cream in the US. Promiseb, a treatment for seborrheic dermatitis, is noteworthy as it prescription only but has no active ingredients.
We know from the 2015 Investor Day presentation some more background on how Dr Reddy and Promius Pharma are positioning DFD-09 as a new product, related to, but differentiated from Oracea.
- Modified release doxycycline indicated for rosacea
- Label similar to Oracea but pursuing claims for dosage without regard to meals.
- Intent to supplement NDA with additional clinical trials to drive differentiation
- Promius files NDA for modified release tetracycline DFD-09
- Oracea Too Expensive ?
- Is Oracea different to 50mg a day of Doxycycline ?
- Step backwards for Generic Oracea. Invalid patents are back
- Say goodbye to Generic Oracea
- Oracea and Finacea prescription prices are increasing !
- How much do Rosacea Prescriptions Really Cost?