Generics/News

Mylan and Par pass FDA scrutiny on Wellbutrin generics

Generics/News | Posted 06/09/2013

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

Generics/News | Posted 30/08/2013

Following the publishing of draft guidance on cyclosporine by FDA, ophthalmic specialist Allergan is requesting that FDA revise its guidance on cyclosporines, arguing that generic versions of its eye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

Generics/News | Posted 23/08/2013

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

Generics/News | Posted 23/08/2013

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

Generics/News | Posted 09/08/2013

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

Generics/News | Posted 02/08/2013

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.

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