Par launches generic version of Provigil
WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.
Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.
The launch occurred under an agreement between the Federal Trade Commission and Teva Pharmaceutical Industries, which acquired Cephalon, the maker of Provigil, in October 2011. On Thursday, Teva — which launched an authorized generic version of Provigil on March 29 — said the Food and Drug Administration has found it was the sole first filer of a regulatory approval application for generic Provigil.
Mylan sued the FDA in a federal court in response to the decision, saying that Teva had forfeited its right to submit an approval application for generic Provigil that challenged what was now its own patent, and that Mylan should be recognized as the first-to-file company instead.
Provigil has annual sales of about $1.1 billion, according to IMS Health.
Teva entitled to exclusivity on Provigil, FDA decides
JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.
Teva said the FDA granted it 180 days of market exclusivity for a generic version of Cephalon’s Provigil (modafinil) after determining that it was the sole first-to-file company; under FDA regulations, the first company to successfully file for approval of a generic version of a drug with a Paragraph IV certification — a legal assertion that the drug’s patents are invalid, enforceable or are not infringed — gets 180 days of exclusivity in which to compete directly against the branded version.
Teva launched an authorized generic version of Provigil at the end of March and said it also expects Par Pharmaceutical to launch a generic version of Provigil on Friday under an agreement with the Federal Trade Commission related to Teva’s October 2011 acquisition of Cephalon. An authorized generic is the branded version of the drug marketed under its generic name at a reduced price.
In response to the FDA’s decision, Mylan filed suit against the agency on Thursday in the U.S. District Court for the District of Columbia seeking to overturn it. Mylan said that Teva could no longer submit an approval application with a Paragraph IV certification due to its acquisition of Cephalon because it could not infringe its own patents. Mylan said that it should be considered the first-to-file company and that Cephalon had previously agreed to its launch of a generic version of Provigil no later than this Friday.
Provigil, which is used to treat conditions like shift work sleep disorder and narcolepsy, had annual sales of about $1.1 billion, according to IMS Health.
Pertussis vaccine offered at Albertsons/Sav-On pharmacies
FULLERTON, Calif. — Supervalu announced that its Albertsons/Sav-On banner is offering inoculations for whooping cough at 54 of its pharmacies in Washington.
The pertussis “Tdap” vaccine booster is recommended for those ages 11 years and older. Albertsons/Sav-On pharmacists are available to administer the vaccination to patients ages 12 years and older, the company said.
The vaccine is available without a prescription or appointment at $54.99 per immunization and a majority of prescription insurances are accepted.
For more details regarding the Tdap immunization and pharmacy hours of operation, call 1-877-728-6655 or visit SavOn.com.