25mg dosage strenght for the OTC market in film coated tablets
Full description
Registered in one EU country and an updated CTD Dossier is
available for application in other countries.
The product has been already licensed out
exclusively for Italy to a major undisclosed swiss based
multinational company.
This product has been developed using a very low cost
manufacturing process (dry mixing for direct compression)
enabling Licensees to have the right margins for a
successful promotion of the Product.
Finally the tablet is film coated to ease swallowing.
This formulation has been developed for the OTC market.
In fact, provided that:
a) Diclofenac Na is the only Diclofenac Salt that can be
switched from the RX to the OTC because it is the only salt
for which enough safety and pharmacovigilance data are
available to justify the switch
b) 25mg Diclofenac Na tablet is already OTC in one EEC
country (Italy) for more than 10 years
The most promising marketing opportunity is:
1) RX to OTC switch strategy
2) Brand Strategy in the OTC field
The requirements to be succesful in the OTC field are:
1. FAST ACTING PRODUCTS to claim real analgesic activity
without major GI side effects
2. To have a line of products to build a BRAND STRATEGY
3. To have PATENTED PRODUCTS to avoid competitors
APR's Diclofenac based formulations answer them all.
Development status
Registered
Patent information
The patent has been granted in the following countries:
Europe, South Africa, New Zealand, Australia and Poland.
The Patent is still pending in the following countries:
Argentina, Canada, Switzerland, Taiwan, USA.
Type of business relationship sought
Licensing agreement in the still available countries.
APR is a Swiss based R&D company offering innovative patent protected products for out-licensing as well as integrated and centrally managed R&D services on a contract basis.