Generics/News
Ranbaxy faces lawsuit in India
An Indian lawyer has filed a lawsuit asking the Indian Supreme Court to investigate Ranbaxy Laboratories (Ranbaxy), its executives and Indian drug control officers, as well as to shut down two of Ranbaxy’s Indian plants.
Actavis submits ANDAs for two more generics
Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.
Teva and Sun Pharma settle battle over generic Protonix
Pfizer announced on 12 June 2013 that the pharma giant had reached a settlement with generics manufacturers Teva Pharmaceuticals Industries (Teva) and Sun Pharmaceutical Industries (Sun Pharma) for damages resulting from their ‘at-risk’ launches of generic pantoprazole in the US.
Dr Reddy’s and Fujifilm call off joint venture for generics in Japan
Two years after signing a deal to work together on generics in Japan, Fujifilm Corporation (Fujifilm) and Dr Reddy’s Laboratories (Dr Reddy’s) have called off their agreement.
US appeals court halts Pulmicort generics
On 25 May 2013, the US Court of Appeals for the Federal Circuit issued a temporary injunction in the US stopping generics of AstraZeneca’s asthma treatment Pulmicort Respules (budesonide inhalation suspension).
Ranbaxy pays US$500 million to resolve US litigation
In what has been hailed as the largest ever settlement of its kind involving a drug safety settlement with a generics manufacturer, Ranbaxy Laboratories (Ranbaxy) pleaded guilty to violations of the Food, Drug and Cosmetics Act (FDCA) and making false statements.
Sanofi fined for discouraging generic clopidogrel prescriptions
On 14 May 2013, French drugmaker sanofi-aventis was fined Euros 40.6 million by the French competition authority (L’Autorité de la concurrence) for marketing practices that discouraged sales of generic versions of its blood thinner Plavix (clopidogrel).
FDA rejects Endo petition to stop Opana ER generics
On 10 May 2013, FDA announced that it had rejected a petition by Endo Pharmaceuticals (Endo) to stop generics of its powerful painkiller, Opana ER (oxymorphone).
Actavis makes agreement for generic abuse-deterrent oxycodone
US generics maker Actavis (formerly Watson) announced on 26 April 2013 that it had reached an agreement with Purdue Pharma (Purdue) to settle all outstanding patent litigation related to Actavis’ generic version of Purdue’s abuse-deterrent formulation of OxyContin (oxycodone).
Daiichi Sankyo and Ranbaxy announce synergy in Brazil
India-based Ranbaxy Laboratories (Ranbaxy) and its Japanese parent company Daiichi Sankyo announced on 17 April 2013 plans to integrate their generic and brand-name drug business operations in Brazil.