Generics/News

FDA approves rare disease deflazacort at exorbitant price

Generics/News | Posted 17/03/2017

Deflazacort is a steroid treatment that has long been approved in many countries outside the US. In February 2016, the US Food and Drug Administration (FDA) approved Marathon Pharmaceuticals’ deflazacort (Emflaza) for the treatment of Duchenne muscular dystrophy. However, it is reported that the drug will come with a devastating price-tag of US$89,000 a year, far more than prices charged abroad.

Generic lung cancer treatment now available in China

Generics/News | Posted 10/03/2017

A generic version of AstraZeneca’s Iressa (gefitinib) has been released onto the market in China. This generic drug is being marketed under the brand name Yiruike and is produced by Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu).

US approves generic of narcolepsy drug Xyrem

Generics/News | Posted 24/02/2017

The US Food and Drug Administration (FDA) has approved the first generic version of Xyrem (sodium oxybate) – the only drug approved to treat the sudden muscle weakness seen in narcolepsy.

Endo launches generic version of Zetia

Generics/News | Posted 27/01/2017

Ireland-based Endo International plc has announced that its operating company Par Pharmaceutical will ship the first generic version of Merck & Co’s blockbuster cholesterol medication Zetia.

Natco Pharma and Alvogen launch first US Tamiflu generic

Generics/News | Posted 20/01/2017

Natco Pharma (Natco) and their marketing partner Alvogen have launched the first generic equivalent of Roche’s flu treatment Tamiflu (oseltamivir phosphate) in the US.

Mylan launches generic EpiPen

Generics/News | Posted 13/01/2017

US-based drugmaker Mylan announced on 16 December 2016 that it had launched the authorized generic version of its EpiPen (epinephrine) injectors at a wholesale price of US$300 per two-pack. This price, the company says, ‘is more than 50% lower’ than the brand-name price.

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

Generics/News | Posted 06/01/2017

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/News | Posted 02/12/2016

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/News | Posted 18/11/2016

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

Generics/News | Posted 28/10/2016

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

Generics/News | Posted 21/10/2016

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

Generics/News | Posted 30/09/2016

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

Generics/News | Posted 23/09/2016

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

Generics/News | Posted 16/09/2016

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

Generics/News | Posted 02/09/2016

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

Generics/News | Posted 26/08/2016

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

Launches, approvals and court cases for Sun Pharma

Generics/News | Posted 19/08/2016

India’s largest drug manufacturer Sun Pharmaceutical Industries (Sun Pharma) has launched ready-to-administer anticancer drug gemcitabine in six European countries and gained approval for a generic version of prescription cholesterol medicine Crestor, while also facing legal action from protesting employees.

FDA approves first generic nilutamide for treatment of prostate cancer

Generics/News | Posted 12/08/2016

US generics producer ANI Pharmaceuticals (ANI) announced on 18 July 2016 that it had received US Food and Drug Administration (FDA) approval for its generic version of prostate cancer treatment Nilandron (nilutamide).

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