Spain granted an SPC for Galliprant® on March 6, 2019, a veterinary drug product developed by Aratana Therapeutics Inc. (Aratana), and marketed by Aratana and Elanco Animal Health Inc. (Elanco) in the United States. The SPC extends the period of exclusive sales rights for Galliprant® until March 1, 2031. Additional SPCs for Galliprant® are currently under examination in several major EU countries. The grant in Spain marks the third approval in the EU, following grants received in Italy and Holland in August 2018.
Galliprant® (grapiprant tablets) is a prostaglandin E2 (PGE2) EP4 receptor antagonist for the control of pain and inflammation associated with osteoarthritis in dogs. Galliprant® has been been granted marketing authorization by the European Commission on January 11, 2018 and Elanco is preparing to launch sales.
Supplementary Protection Certificate (SPC)
In major countries around the world, a patent generally expires after 20 years following submission of the patent application. However, the patent exclusivity periods for pharmaceuticals may be extended for a maximum of five years in order to compensate for the time consuming and costly research and development. The SPC grant by Spain for Galliprant® represents a five-year extension of the therapy’s exclusive sales period.