Impax Labs files Gralise patent challenge
HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent protection on a drug used to treat postherpetic neuralgia, the company said Thursday.
Impax announced that it had filed a regulatory approval application with the Food and Drug Administration for gabapentin tablets, a generic version of Depomed’s Gralise, in the 300-mg and 600-mg strengths.
The application contained a Paragraph IV certification, a legal assertion that the patents covering the drug are invalid, unenforceable or won’t be infringed. In response, Depomed filed a lawsuit against Impax Tuesday in the U.S. District Court for the District of New Jersey.
Gralise had sales of about $1.3 million during the three-month period ended in February, according to Wolters Kluwer Health.
Valeant acquires Pedinol
MONTREAL — Valeant announced that it has acquired a privately owned specialty pharmaceutical company based in the United States.
Pedinol Pharmacal, a podiatry-focused company that has been in business for more than 85 years, was acquired for an undisclosed amount that was said to be 1.5 times sales. Pedinol touted $18 million in revenue last year.
"The Pedinol business will be a strong fit alongside Valeant’s dermatology franchise," Valeant chairman and CEO J. Michael Pearson said. "The podiatry market has similar characteristics to the dermatology market that we find attractive from a risk and reward aspect, and expanding into this area is a natural extension of our topical formulation development capabilities."
Prasco to market authorized generic Vancocin
CINCINNATI — Prasco Labs will market an authorized generic version of a drug used to treat diarrhea caused by a bacterial infection, the company said Wednesday.
Prasco announced that it had signed a deal with ViroPharma to market an authorized generic version of Vancocin (vancomycin hydrochloride) capsules in the 125-mg and 250-mg strengths. The drug is used to treat diarrhea related to Clostridium difficile infection.
The news follows Watson’s announcement Tuesday that the Food and Drug Administration had approved its generic version of Vancocin. Unlike generic drugs, authorized generics are branded drugs marketed under their generic names at a reduced price under agreements between the original branded drug’s manufacturer and an outside company.
Vancocin had sales of $332 million during the 12-month period ended in February, according to IMS Health.