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Lupin and Natco’s Armodafinil generic approved to treat sleep disorders by FDA

The US subsidiary of Indian drug manufacturer, Lupin Pharmaceuticals, announced on 29 November 2016 that its Armodafinil tablets had received approval from the US Food and Drug Administration (FDA). Marketing and promotion of the product in the US will begin shortly.

Mylan to make generic hepatitis drug under MPP sublicence

Generics giant Mylan Pharmaceuticals (Mylan) announced on 28 November 2016 that the company had signed a sublicence with the Medicines Patent Pool (MPP) to make a generic of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

Dr Reddy’s makes deal with Gland Pharma for US injectables

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 October 2016 that it had entered into a ‘strategic collaboration’ with India-based sterile dosage form maker Gland Pharma.

Teva sells Actavis’ UK and Ireland generics business to Intas

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 5 October 2016 that it had agreed to sell the UK and Ireland generics business of Actavis to Accord Healthcare (a subsidiary of Intas Pharmaceuticals) for GBP 603 million, subject to final approval from the European Commission (EC).

Mylan agrees to pay fine over EpiPen rebates

US-based drugmaker Mylan announced on 7 October 2016 that it had agreed to pay US$465 million to the US Department of Justice (DOJ) and other government agencies. The agreement, the company says, will resolve questions that have been raised about the classification of its EpiPen injectors for the Medicaid Drug Rebate Program. The deal has also been made without the company having to admit any wrongdoing.

Teva recalls antibiotic and anti-seizure drug

Recent US Food and Drug Administration (FDA) reports have caused Israeli generics producer Teva Pharmaceutical Industries (Teva) to recall a treatment for seizures, as well as an antibiotic made at its sterile manufacturing plant in Hungary.

Allergan allows Amneal to market Alzheimer’s generic in 2025

Allergan has reached a deal with Amneal Pharmaceuticals (Amneal) over Allergan’s Alzheimer’s drug Namzaric. The agreement will enable Amneal to market generic versions of the drug from 2025 onwards. 

Patent wins and losses for Teva

Teva Pharmaceutical Industries (Teva) – the world’s largest generics manufacturer – has reported a string of patent updates recently. In the first of Teva’s patent-related news, Forest Laboratories (Forest) – an American pharmaceutical company acquired by Actavis [1] – made a deal with Teva regarding a patent licensed to them and held by Mayne Pharma (an Australian specialty injectables company now owned by Pfizer).

Senators continue to raise concerns over price of Mylan’s EpiPen

On 30 August 2016, a group of 20 US senators led by democrat Elizabeth Warren sent a letter to Mylan’s CEO Heather Bresch expressing their ‘serious concerns’ about the company’s recent significant price hikes for the life-saving EpiPen Auto-Injector.

New generic versions of imatinib mesylate join the US market

Two new generic versions of Novartis’ imatinib mesylate (marketed as Gleevec® and Glivec®) were launched in the US in early August 2016.

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