We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has not received a single polymorph patent for filing in the Orange Book since new drug patent rules went into effect last year, according to FDA officials, who are seeking input on implementing the changes to the Hatch-Waxman Act patent law.
In a precedent-setting case involving the controversial declaratory judgment provision in last year’s drug patent reforms, the FTC and the AARP are supporting Teva Pharmaceuticals’ bid to convince a federal district court to hear its patent challenge against Pfizer’s lucrative antidepressant Zoloft (sertraline HCl).
Generic firm Apotex said its version of GlaxoSmithKline’s antidepressant Paxil (paroxetine HCl) garnered sales of about $150 million to $200 million during its 180-day exclusivity period — a return far smaller than what it had expected because of an authorized generic competitor.
The Generic Pharmaceutical Association (GPhA) has come out against the practice of generic firms cutting deals with brand firms to market authorized versions of their products — a practice the trade group contends devalues the 180-day exclusivity provision in the federal drug patent law.
To help generic drug manufacturers determine if they are eligible for marketing exclusivity, the FDA will soon list on its website the date it receives the first substantially complete new drug application challenging a patent on a brand drug.
While reforms to the Hatch-Waxman Act aim to cut down on abuses of the drug patent system, a provision in the law may still let brand firms delay generic competition by simply not listing all of their patents in the FDA’s Orange Book.