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Dey wants the FDA to provide a written confirmation that it is entitled to a 30-month stay after suing Ivax over its patent challenge to Dey’s inhalation lung disease treatment, DuoNeb.
In an abrupt move, Mylan Pharmaceuticals dropped its lawsuit against the FDA over the agency’s July decision to allow brand-authorized generic drugs to compete with true generics during a firm’s 180-day marketing exclusivity period.
The FDA has disregarded its own precedent that authorized generics are functionally and legally equivalent to true generics by allowing a brand-authorized generic to launch during Mylan Pharmaceutical’s generic marketing exclusivity period, Mylan argued in a lawsuit.
Despite sweeping new patent rules implemented last year to better balance the competition between brand and generic drugmakers, generic firms say the brand firm practice of making deals with generic firms to market authorized generic products is a threat to the industry.
Andrx has relinquished its 180-day exclusive marketing rights for a 150-mg strength version of GlaxoSmithKline’s (GSK’s) smoking cessation drug Zyban (bupropion HCl), a move that allows generic firms to start marketing the drug.
PhRMA is urging the FDA to implement an administrative penalty to discourage generic firms from missing deadlines for submitting notifications that start the 45-day clock for drugmakers to file patent-infringement lawsuits.
The FDA should add regulatory language to rules governing brand-generic competition that would expressly require a brand firm to correct or delete patent information when a court order requires such a patent change, the Generic Pharmaceutical Association (GPhA) said in comments suggesting changes in FDA drug patent rules.
The FDA should implement an administrative penalty to discourage generic firms from missing deadlines for submitting notifications that start the 45-day clock for drugmakers to file patent-infringement lawsuits, PhRMA said in comments suggesting changes in FDA drug patent rules.
While the effects of last year’s drug patent reforms are still sinking in, one change has become clear: The agency has not received a single polymorph patent for filing in the FDA’s Orange Book since the new rules kicked in last August, according to agency officials.
Since new drug patent rules went into effect last year, the FDA has not received a single polymorph patent for filing in the Orange Book, according to agency officials, who are seeking input on implementing the changes to the Hatch-Waxman Act patent law.