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Following the publishing of draft guidance on cyclosporine by FDA, ophthalmic specialist Allergan is requesting that FDA revise its guidance on cyclosporines, arguing that generic versions of its eye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

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).

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