Generics/News

Ranbaxy faces lawsuit in India

Generics/News | Posted 28/06/2013

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

Generics/News | Posted 21/06/2013

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

Generics/News | Posted 14/06/2013

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

Generics/News | Posted 07/06/2013

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

Generics/News | Posted 31/05/2013

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

Generics/News | Posted 24/05/2013

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

Generics/News | Posted 17/05/2013

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

Generics/News | Posted 17/05/2013

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

Generics/News | Posted 03/05/2013

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

Generics/News | Posted 29/04/2013

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.

Mylan gains approval for generic of Valeant’s Zovirax

Generics/News | Posted 19/04/2013

Generics giant Mylan announced on 3 April 2013 that its subsidiary Mylan Pharmaceuticals had received final approval from FDA for its abbreviated new drug application (ANDA) for acyclovir ointment 5%.

AstraZeneca settles rosuvastatin lawsuit

Generics/News | Posted 19/04/2013

UK-based AstraZeneca announced on 25 March 2013 that it had entered into a deal concerning US patent infringement litigation against Actavis (formerly known as Watson Pharmaceuticals) and EGIS Pharmaceuticals with respect to Actavis’ generic rosuvastatin zinc product.

New entrant to generic injectables market

Generics/News | Posted 12/04/2013

Medical technology company Becton Dickinson announced on 28 March 2013 that FDA had approved the first drug in its line of prefilled generic injectables. This can only be good news for FDA who has been fighting to alleviate drug shortages in the US, most of which are due to shortages in generic sterile injectables.

Mylan launches generics and reaches settlement over metformin

Generics/News | Posted 05/04/2013

Generics giant Mylan has launched generic versions of fenofibrate capsules, cidofovir injection and levalbuterol. The company has also resolved patent litigation with Shionogi and Andrx related to metformin.

Mylan to acquire Strides Arcolab’s injectable generics business

Generics/News | Posted 15/03/2013

Generics giant Mylan announced on 27 February 2013 that it has signed an agreement to acquire generic injectables maker Agila Specialties (Agila) from Strides Arcolab for US$1.6 billion in cash.

Actavis confirms generic Alzheimer’s patch patent challenge

Generics/News | Posted 22/03/2013

US generics maker Actavis (formerly Watson) confirmed on 8 March 2013 that it had filed with FDA an amendment to its abbreviated new drug application (ANDA) for rivastigmine transdermal system to include the 13.3 mg/24 hr dosage strength. Actavis’ product is a generic version of Novartis’ Exelon Patch, which is used to treat people with mild to moderate dementia associated with Alzheimer’s or Parkinson’s disease.