Generics/News
Ranbaxy receives another import ban from FDA
Ranbaxy Laboratories (Ranbaxy) has come into FDA’s firing line again. This time generics manufacturer is under scrutiny for problems at its Mohali manufacturing site.
Avanir and Wockhardt settle Nuedexta patent dispute
US-based Avanir Pharmaceuticals (Avanir) announced on 6 September 2013 that it had entered into a settlement agreement with Wockhardt USA, the US subsidiary of India-based generics maker Wockhardt, regarding Nuedexta (dextromethorphan hydrobromide/quinidine sulfate).
Actavis confirms Rayos patent challenge and Warner Chilcott acquisition
Actavis has filed for US approval for a generic version of the anti-inflammatory or immunosuppressive agent Rayos (prednisone). The company also confirmed its proposed acquisition of Warner Chilcott.
Ranbaxy to expand Russian portfolio
Generics manufacturer Ranbaxy Laboratories (Ranbaxy) has been in the Russian pharmaceuticals market for 20 years and is now considering expanding its product offering in the country.
Mylan and Par pass FDA scrutiny on Wellbutrin generics
Mylan and Par Pharmaceutical (Par) announced on 20 and 22 August 2013, respectively, that they have passed FDA scrutiny of their generics of antidepressant Wellbutrin XL (bupropion).
Allergan objects to Restasis generics being accepted without human trials
Following the publishing of draft guidance on cyclosporine by FDA, ophthalmic specialist Allergan is requesting that FDA revise its guidance on cyclosporines, arguing that generic versions of its eye drug Restasis (cyclosporine ophthalmic emulsion) should be tested in humans before approval, not just in a laboratory.
Eli Lilly attempts to further delay Alimta generics
Pharma giant Eli Lilly was scheduled to be in court on 19 August 2013 to defend another of its patents on its blockbuster lung cancer drug Alimta (pemetrexed).
Pfizer’s US$2.15 billion settlement with Teva and Sun Pharma
Pfizer announced in June a US$2.15 billion settlement with Teva and Sun Pharmaceutical Industries (Sun Pharma) for patent-infringement damages resulting from unlawful launches of generic Protonix (pantoprazole) in the US.
Perrigo receives tentative FDA approval for generic Prandin
US-based drugmaker Perrigo Company (Perrigo) announced on 19 July 2013 that it had received tentative approval from FDA for its abbreviated new drug application (ANDA) for repaglinide tablets.
Teva loses fight against generic glatiramer acetate
On 26 July 2013 the US Federal Circuit Court of Appeals invalidated several of Teva’s patents on Copaxone (glatiramer acetate), including one that protected the drug until September 2015.
