Shire given market exclusivity for ADHD drug
PHILADELPHIA The U.S. District Court for the District of Columbia has upheld a decision by the Food and Drug Administration to give exclusivity to a Shire drug for attention-deficit hyperactivity disorder, Shire announced Thursday.
The FDA gave the ADHD drug Vyvanse (lisdexamfetamine diemsylate) five years of market exclusivity on account of its being a new chemical entity in 2007. For that reason, it refused to file an approval application for a generic version of the drug submitted by Actavis Elizabeth. Actavis sued the FDA in February 2009 in the court to challenge the FDA decision.
The five-year exclusivity period for Vyvanse will expire in February 2012, precluding generic manufacturers from submitted applications for knock-off versions until then, or until February 2011, if a generic applicant challenges the drug’s patents, which expire in June 2023.
Pfizer may buy Ratiopharm
NEW YORK It appears that Pfizer has changed its mind a second time about buying Ratiopharm.
According to published reports, Pfizer has renewed its offer for the German generic drug maker, for $4 billion. That pits the world’s largest drug maker against generic drug makers Teva Pharmaceutical Industries and Actavis.
Pfizer has been on a hunt for opportunities lately, most notably with its acquisition of Wyeth, as it faces patent expirations on such high-selling drugs as the cholesterol medication Lipitor (atorvastatin).
Walgreens completes acquisition of SpecialtyScripts
DEERFIELD, Ill. Walgreens has completed its acquisition of prescription files from Cardinal Health subsidiary SpecialtyScripts, based in Fall River, Mass., Walgreens announced Wednesday.
Founded in 2002, SpecialtyScripts niche is in providing specialty pharmacy services for such chronic illnesses and complex diseases as hepatitis C, psoriasis, rheumatoid arthritis and oral oncology.
Walgreens said the acquisition would allow Walgreens Specialty Pharmacy to scale the operations of its existing locations. Financial terms of the deal were not disclosed.
“We’re excited about our acquisition of SpecialtyScripts and see it as an opportunity to grow our specialty pharmacy business through additional preferred payer agreements,” Walgreens Specialty Pharmacy EVP and Walgreens divisional VP Michael Nameth said in a statement. “It’s a good fit for us because SpecialtyScripts has a similar client base, and we share a commitment to providing patients and customers with quality care and exceptional service.”