Generics
FDA grant to study generic versus brand-name transplant drugs
FDA has given a grant to the University of Cincinnati, Ohio, USA, in order to support a study into a commonly used immunosuppressive drug for transplant patients, tacrolimus.
German court rules Seroquel XR patent invalid
AstraZeneca has lost another battle to protect its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) against generics.
EMA approves first generic imatinib
EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib.
Overview of clinical research on generics in 2012
Period: January to August 2012
Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to contain healthcare costs and as an increasing number of prescription drugs lose patent protection.
FDA ordered to let Watson sell generic Actos
Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered FDA to approve Watson’s generic pioglitazone against the agency’s decision to bar Watson during the first six months of generics availability.
Momenta versus Amphastar and the safe harbour provision
On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reasonably related’ to the submission of information to FDA. The case involved was that of Momenta Pharmaceuticals (Momenta) versus Amphastar Pharmaceuticals (Amphastar) (Federal Circuit No. 2012-1062, 8/3/12).
Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity
US-based Mylan has sued FDA for refusing to grant approval to sell a generic version of Novartis’s heart treatment, Diovan HCT (valsartan/hydrochlorothiazide), ‘after a competitor failed to get the drug on the market in time’.
Teva withdraws generic antidepressant from US
Israel-based Teva Pharmaceutical Industries (Teva), the world’s largest generics manufacturer, has removed its Budeprion XL 300 mg generic version of GlaxoSmithKline’s antidepressant Wellbutrin XL (bupropion) from the US market after regulators said it is not therapeutically equivalent to Wellbutrin XL 300 mg.
FDA gives generics greater importance
The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated with generics.
Mylan debuts first generic Diovan HCT and Antivert in USA
Mylan is first off the mark once again with its latest generics launch. Mylan announced on 21 September 2012 that its subsidiary Mylan Pharmaceuticals has received final approval from FDA for its Abbreviated New Drug Application (ANDA) for valsartan/hydrochlorothiazide tablets USP.
