Allergan and Ironwood Pharmaceuticals have reached an agreement that will keep generic copies of Linzess (linaclotide) off the US market until 2029.
Linzess, a guanylate cyclase‐C agonist used to treat irritable bowel syndrome with constipation and chronic idiopathic constipation, has been the subject of interest from multiple generic companies. In recent years, Allergan and Ironwood have reached settlements with all bar one of those companies, namely Teva Pharmaceutical.
That changed on Wednesday when Allergan and Ironwood revealed they had reached a settlement with Teva covering an abbreviated new drug application for generic versions of 145 mcg and 290 mcg Linzess.
Under the terms of the settlement, Allergan and Ironwood have agreed to grant Teva a license to sell the drugs in the US from the end of March 2029 onward. The agreement does not cover Teva’s 72 mcg generic version of Linzess.
Allergan and Ironwood had previously entered into settlements with other generic companies such as Aurobindo Pharma, Mylan and Sandoz. In those agreements, Allergan and Ironwood agreed to give out licenses in 2030, suggesting Teva will have a head start over other companies with generic copies of Linzess.
In resolving all of the patent disputes, Allergan and Ironwood have positioned themselves to focus on growing sales in the face of competition from other molecules over the next nine years.
Net US sales of Linzess amounted to $572m (€516m) over the first nine months of 2019. The figure reflects the dominant position of Linzess, which Bausch Health, a manufacturer of a rival drug, thinks controls around two-thirds of the market.
In the absence of generic competition, rival branded medicines such as Trulance (plecanatide), another guanylate cyclase-C agonist sold by Bausch, represent the main threat to Linzess.
Trulance may be the subject of generic competition in the coming years, exposing Linzess to more low-priced rivals, but Ironwood thinks its dominant market position will insulate it from that threat.
“They have a minimal presence in the marketplace. I think we've demonstrated that linaclotide has a very, very strong brand profile. And the reason that it continues to perform so well is obviously the overall satisfaction that we're seeing from both patients and physicians as well as what we've been able to do with payers,” Ironwood CEO Mark Mallon said on a conference call with investors last year.
Ironwood is also looking to ex-US markets for growth, winning approval in China last year.