- Allergan could face a new patent risk for its key eye drug Restasis, facing off against generics and specialty pharma Mylan Pharmaceuticals, a subsidiary of the global Mylan N.V.
- The U.S. Patent Office's Patent Trial and Appeal Board (PTAB) granted Mylan's petition to launch an inter partes review of six Restasis patents, which are due to expire on August 27, 2024. A decision on the reviews, which will assess the patentability of Allergan's claims, is expected in late 2017.
- Net revenues from the sales of Restasis in the U.S. totaled $356.4 million in the third quarter of 2016, making the drug Allergan's second best-selling product behind Botox.
Besides Mylan, several other companies are also working to develop generic forms of the eye-drug. If and when generic competition is allowed to go ahead, Allergan could see significant lower sales.
According to the IMS Institute for Healthcare Informatics, losing market exclusivity in the U.S. reduces drug prices by 51% in the first year and 57% in the second year on average, with generic oral medicine prices falling by 80% within five years.
Allergan's Restasis, a cyclosporine ophthalmic emulsion approved to treat chronic dry eye, acts by increasing the ability to produce tears.
"Allergan is disappointed in the PTAB's decision to institute IPR proceedings regarding the patents that protect Restasis," the company said in a statement.
"Allergan is currently reviewing the grounds for the decision to institute, and will continue to vigorously defend the patents in the IPR proceeding and pursue all legal options available to protect its products and intellectual property rights for this product."
Umer Raffet of Evercore ISI suggests that the FDA's review of Restasis generics "may be much more complex than [Wall] Street is anticipating. In theory, this could result in delayed approval timelines for generics."
This isn't the first go-round in Allergan's fight to defend its Restasis patents. In December 2014, Allergan argued in a citizen petition that bioequivalence standards couldn't guarantee that a generic would be equivalent to Restasis. However, the FDA rejected this, stating that it had "clear and legal authority" for approving generics without human testing.