Last month, GlaxoSmithKline, the maker of Flonase, a nasal spray for allergies, sued the FDA to block the competition, generic makers Roxane Laboratories and Par Pharmaceuticals, winning a temporary restraining order that had suspended sales. Glaxo’s legal fight stalled shipments of Roxane’s competitor and Par’s version as well even though Par makes a Glaxo-authorized generic. At a hearing Monday, the U.S. District Court in Maryland refused to extend the restraining order, backing FDA’s approval of Roxane’s generic last month.
Money money money… GlaxoSmithKline sold nearly $1.2 billion in Flonase worldwide last year. Generics typically cost 30 percent to 80 percent less than their brand-name counterparts. Greed or intellectual property?
GlaxoSmithKline alleges the FDA failed to follow its own regulations in approving the Flonase generic and failed to apply the same quality standards… The company made the same arguments in petitions it filed with the FDA. The FDA rejected those petitions.
New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions. The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.