Restasis what approved by the FDA and introduced in the US in 2003. Patent laws would have made a generic possible in 2015 (12 years). Allergan has taken the unusual step of considering selling their patent to a Native American tribe to obtain sovereign immunity. It did not work. Allergan CEO Brent Saunders is trying to delay a generic as long as possible as they the generate greater than $1B per year from this drug. Now Canada has a generic made by Teva. Teva and Mylan are fighting to make a generate in the US.
Allergan took an expensive risk to develop topical cyclosporin into a useable drug for severe dry eye. By all measures it has been a huge success and helped huge numbers of patients. They deserve to generate a profit for their innovation. However, enough is enough. It is time to lower the costs on this mature drug. Allergan should develop a new, better drug to start the whole process again and capture the rewards.