research and development costs. galderma for reference had fourteen yrs of exclusivity of selling.
fortunate to have the money at this time.
all are correct smoke and mirrors.
also agree with your thought process.
galderma original patent "expired" in 2010. avanir pharmaceutical patents expire in 2016, 2023, 2026.
galderma reformulated fda approved product with an "expired" patent in 2010. avanir reformulated non fda approved product with the longest patent expiring in 2026.
galderma's adapalene for starters received fda approval in 1996. adapalene .1 percent went generic in 2010. galderma reformulated adapalene to .3 percent... and generic drug companies now want to sell .3 percent. galderma not the generic drug companies invested the time and the financial resources. drug discovery could be materially hurt if the courts don't over turn the 2 to 1 decision in January 2014.
avanir pharmaceuticals original formulation with higher quinidine was denied approval. avanir could have decided not to go forward and risk more capital and end the to trials. avanir proceeded and identified the safe magic q/dm formula and received fda approval in October 2010. launched nuedexta in february 2011.
galderma recouped their r&d expenses and made a profit with 14 years of exclusivity. avanir has had three yrs of exclusivity due to the down time of launching a new drug and hiring a new sales group, and has yet to recoup their r&d expenses. innovation and discovery is at risk if the courts do not over turn the Dec 11 judges 2 to 1 panel ruling when the entire judges in the court review the 3 judges panel decision.
the galderma co. had a precedent with an approved fda product. avanir pharma had no idea the new formulations would even work or receive government approval.