Mylan looks to market generic Lidoderm
CHADDS FORD, Pa. — Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.
Endo said Monday that Teikoku Seiyaku and U.S. subsidiary Teikoku Pharma USA had received a Paragraph IV certification from Mylan stating the latter’s intention to market a generic lidocaine topical patch. The drug is a generic version of Endo’s and Teikoku’s Lidoderm.
Under the Hatch-Waxman Act of 1984, a Paragraph IV certification is an assertion included with a regulatory approval application that the patents covering a drug are invalid, unenforceable or won’t be infringed by a generic version. In this case, the certification refers to patents that expire in March 2014 and October 2015.
Endo said it would “vigorously defend” its intellectual property rights. Under Hatch-Waxman, the drug maker is allowed to sue Mylan for patent infringement, which would put an automatic stay of final Food and Drug Administration approval on Mylan’s generic version that would expire after 30 months or when the companies reach a settlement.
Pfizer: Tender offer for King completed
NEW YORK — Pfizer has completed its tender offer for Bristol, Tenn.-based King Pharmaceuticals, Pfizer said Monday.
Pfizer said 230.7 million shares valued at $14.25 each were tendered, representing about 92.5% of King.
Pfizer made its $3.6 billion offer for King in October 2010. The offer cleared the waiting period mandated by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 on Friday.
Transcept announces PDUFA action date for Intermezzo
POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker’s insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.
Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.
Intermezzo is a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.