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AstraZeneca settles rosuvastatin lawsuit

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

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 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 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

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.

Pfizer delays generic celecoxib entry in US

Pharma giant Pfizer announced on 5 March 2013 that the US Patent Office had given the company an extra 18 months of exclusivity for its blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

FDA approves generic opiate-dependency drugs

On 22 February 2013, FDA approved two generic versions of the drug Suboxone (buprenorphine/naloxone), a treatment for recovering heroin addicts.

Ranbaxy restarts generic atorvastatin production

India-based generics giant Ranbaxy Laboratories (Ranbaxy) announced on 25 February 2013 that it has restarted production of its generic cholesterol lowering drug atorvastatin after solving contamination problems.

Pfizer asks US Court to reconsider generic Reglan ruling

Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers.

Watson buys women’s health company Uteron

Generics giant Watson Pharmaceuticals, now known as Actavis, announced on 23 January 2013 that it has completed the acquisition of Belgium-based Uteron Pharma for US$150 million in cash up front, and up to US$155 million in potential future milestone payments.

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