Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The Generic Pharmaceutical Association has praised legislation introduced by US senators that would amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generics during the 180-day exclusivity period of generic pharmaceutical patent challengers.
Subscribe to our email newsletter
The Generic Pharmaceutical Association (GPhA) said the measure will close another loophole that needlessly delays generic entry into the market. The association claims this tactic has been used extensively by the branded pharmaceuticals industry over the past three years and has upset the balance of the Hatch-Waxman Act by discouraging investment in generic patent challenges.
“Not only do authorized generics devalue the 180-day incentive, but they also reward the brand companies by enabling them to garner additional profits for their authorized generic product during the 180-day generic exclusivity period – which undermines the system – despite having lost in the patent challenge,” stated Kathleen Jaeger, president and CEO of GPhA.
“This measure will prevent the brand industry from re-labeling their brand product and marketing it as a generic during the exclusivity period that generic companies earn by investing millions of dollars and years of time in challenging inappropriate or invalid patents that prevent competition and keep brand drug prices artificially high,” she continued.