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Out-licensing

Diclofenac potassium oral drops at 5%

APR Applied Pharma Research S.A.
The first pure, immediate release (Tmax in 13,68 min), completely palatable and free from aftertaste diclofenac potassium formulation in drops at 5% available on the market

Full description

The product is approved in The Netherlands for the treatment of the acute painful conditions such as headache, toothache, menstrual pain,etc. and it is approved in Germany for the indication Migraine. Our formulation in drops at 5% has the main following marketing claims: First drop formulation at 5% available on the market: Tmax comparable to injectable forms: Our formulation shows a very quick onset of action and a very good performance in pain relief reaching the Tmax in about 14 min. after administration. Regular absorption and reduction of standard deviation: The formulation contains an excipient, which is the first to react in the site of absorption as a buffering of the pH increasing the same to the optimum level in which diclofenac is absorbed. By this way we obtained regular and standard absorption levels, strongly reducing the great variability of the existing formulations on the market. Production: Our formulations are developed using worldwide accepted pharmaceutical excipients used in a non patent infringing formula and process. In addition our formulations have been developed using a cost saving manufacturing process and formula.

Development status

Registered

Patent information

The patent has been granted in the following countries: Europe, South Africa, New Zealand, Australia and Poland, Switzerland, USA, Taiwan. The Patent is still pending in the following countries: Argentina, Canada.

Type of business relationship sought

The product has been already licensed out non exclusively to an undisclosed German based multinational company and non exclusively for Italy to a local company. Licensing agreements are sought in the still available territories.

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