Patent expirations promise opportunities for generics makers

Patent expirations on branded drugs are the generics industry’s bread and butter — and the years to come hold a lot of promise. QuintilesIMS projects that by 2021, the loss of patent protection is set to reduce spending on branded drugs by $140 billion from current levels. The potential impact is markedly larger than the $93.6 billion that loss of patent protection cost branded medicine companies between 2012 and 2016.

Earlier in 2017, Lilly’s attention deficit hyperactivity disorder treatment Strattera lost patent protection, with four generics hitting the market in early June. But Strattera — whose sales hovered around $590 million in 2016 — was not the heaviest hitter to come off patent this year. 

That title goes to Teva’s Copaxone, which brought in $4.1 billion in invoice-price spending in 2016. In early October, Mylan received approval for both the 20- and 40-mg/ml dosage strengths of the relapsing multiple sclerosis treatment and immediately launched the product. QuintilesIMS vice president industry relations Doug Long noted in a recent presentation that the generic competition — which include both Mylan’s generic and Sandoz’s 20-mg/ml generic offering — could carve a $1 billion to $1.3 billion hole in branded Copaxone profits. 

Also coming up on their patent expiries are the two biggest erectile dysfunction drugs — Eli Lilly’s patent for Cialis expires Nov. 21 and Pfizer’s Viagra patent expires Dec. 11. Cialis had sales in the United States of $1.5 billion in 2016, and could be seen over-the-counter soon. Meanwhile, analysts expect Viagra’s $1 to drop to $359 million as generics — including Greenstone’s authorized generic — get substituted in its place. 

Perhaps this year’s largest open question has been Allergan’s Restasis. The dry-eye treatment brought the company $1.5 billion in 2016 U.S. sales, and Allergan has been trying to retain patent protection on the drug. An October court ruling called the patent into question and gave generics makers — Mylan, Teva and Akorn were listed as co-defendants — hope by ruling that the Restasis patent expired in 2014.

Though Allergan indicated that it would continue to fight for patent protection on the drug, it did not stopped ophthalmology-focused Imprimis Pharmaceuticals from bringing a compounded cyclosporine-based dry eye treatment to market two days after the decision was handed down. Approval for the generics from Mylan, Teva and Akorn is still pending.