FDAnews Drug Daily Bulletin

Wyeth has brought a patent infringement suit to prevent approval of Sandoz’s generic version of the oral contraceptive Lybrel.

In a suit filed in the U.S. District Court for the District of Delaware, Wyeth alleges that Sandoz infringed on the ’814 patent with its ANDA’s Paragraph IV certification to make a generic version of Lybrel (levonorgestrel/ethinyl estradiol). Sandoz informed Wyeth in an April 16 letter that its generic would not infringe on the patent, the patent is invalid or the patent is unenforceable.

Wyeth has asked the court to make the effective date of any FDA approval of Sandoz’s ANDA to be no earlier than the September 2018 expiration of the ’814 patent, according to court documents.

Wyeth’s suit is its second this year in the same court to defend the Lybrel patent. Watson Pharmaceuticals notified the drugmaker in a letter dated Jan. 28 that it had filed an ANDA with a Paragraph IV certification seeking FDA approval to market a generic version of the drug. Wyeth filed its complaint against Watson March 12, according to court documents.