seven-year period of market exclusivity in the U.S. If BNC starts marketing in 2015 or 2016 then this is a monopoly until 2022-2023
from Taylor collision, 2011, it was then until 2027, this is 4 years shelved. At the end second paragraph, the extension will start to expire 2023. Now the orphan drug status seems only useful to lower some fees.
So if BNC mnca does not get orphan status what will be the exclusivity?
Bioniche has retained global manufacturing rights for UrocidinTM and will receive a net sales related price for supplying Endo with UrocidinTM. Endo will be granted a right of first negotiation to other clinical indications of the MCC composition, relating to urology or pelvic disease. The Endo agreement is valid until the latter of: (1) 10 ten years from commencement, (2) a biosimilar is licensed; or (3) the expiry of the last patent claim attributable to UrocidinTM.
As a novel biologic, Bioniche can expect to receive 12 years market exclusivity for UrocidinTM from the date of launch in the US. On our estimates of a 1H CY15 launch, this provides Bioniche with a monopoly position until CY27 (satisfying (2) above). With respect to patent coverage, under existing patent extension legislation (assuming a max. 5 year extension) Bioniche’s MCC (incorporating UrocidinTM) patents would begin to expire progressively from CY23.