Generics/News

Glenmark gains approval for anti-epileptic generic

Generics/News | Posted 24/06/2016

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 19 May 2016 that it had received final approval from the US Food and Drug administration (FDA) for a generic version of Eisai’s epilepsy treatment Banzel (rufinamide).

Dr Reddy’s to buy US generics from Teva

Generics/News | Posted 17/06/2016

Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) announced on 11 June 2016 that it had made a deal with Teva Pharmaceutical Industries (Teva) and an affiliate of Allergan to acquire a portfolio of eight abbreviated new drug applications (ANDAs) in the US.

Dr Reddy’s buys six OTC brands from Ducere Pharma

Generics/News | Posted 03/06/2016

Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) has entered the US branded consumer health products market by acquiring six over-the-counter (OTC) brands from US-based Ducere Pharma.

GSK appeals UK pay-for-delay fine

Generics/News | Posted 27/05/2016

GlaxoSmithKline (GSK) is appealing a GBP 37.6 million fine from the UK’s Competition and Markets Authority (CMA) over pay-for-delay allegations.

FDA approves first generic rosuvastatin

Generics/News | Posted 13/05/2016

The US Food and Drug Administration (FDA) announced on 29 April 2016 that it had approved the country’s first generic version of Astra Zeneca’s leading cholesterol drug Crestor (rosuvastatin).

Sun Pharma to buy 14 drug brands from Novartis in Japan

Generics/News | Posted 22/04/2016

A wholly owned subsidiary of India’s Sun Pharmaceutical Industries (Sun Pharma) will acquire a portfolio of 14 established prescription brands from Novartis and Novartis Pharma in Japan for a sum of US$293 million. This will give Sun Pharma a strong foothold in Japan, the world’s second largest market after the US.

Apotex launches generic of nasal allergy treatment

Generics/News | Posted 15/04/2016

On 24 March 2016, Canada-based Apotex announced that it had launched mometasone furoate monohydrate nasal spray in the US, the first generic version of Merck’s Nasonex. Mometasone furoate monohydrate is a once-daily anti-allergen indicated for the treatment of nasal congestion for adults and children over two years.

Teva launches generic acamprosate in US

Generics/News | Posted 08/04/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 22 March 2016 that it had launched a generic version of alcohol dependence treatment Campral (acamprosate).

FDA approves Teva’s Viagra generic

Generics/News | Posted 25/03/2016

Israeli generics giant Teva Pharmaceuticals (Teva) has received US Food and Drug Administration (FDA) approval for its generic version of Pfizer’s blockbuster erectile dysfunction drug Viagra (sildenafil), which is also called Revatio in the US.

Biocon gets first European generics approval

Generics/News | Posted 04/03/2016

India-based biologicals specialist Biocon announced on 15 February 2016 that it had received its first European generics approval for a generic version of Astra Zeneca’s blockbuster anti-cholesterol drug Crestor (rosuvastatin).

Sun Pharma launches imatinib mesylate in the US

Generics/News | Posted 26/02/2016

On 1 February 2016, Sun Pharmaceutical Industries (Sun Pharma) launched imatinib mesylate in the US, a generic version of Gleevec (imatinib mesylate) developed by Novartis. Sun Pharma received final approval for imatinib mesylate from the US Food and Drug Administration (FDA) in December 2015, and was granted 180 days of marketing exclusivity from the time of its launch.

UK paves way for generics of Eli Lilly’s Alimta

Generics/News | Posted 19/02/2016

The UK High Court ruled on 12 February 2016 that Eli Lilly’s vitamin regimen patent for its lung cancer blockbuster Alimta (pemetrexed disodium) is not infringed by a generic version of the drug sold by Allergan’s Actavis unit.

Mylan launches generic seizure drug in US

Generics/News | Posted 12/02/2016

US generics manufacturer Mylan announced on 19 January 2016 that it had launched a generic version of Meda Pharms’ Felbatol (felbamate) tablets in dosages of 400 and 600 mg in the US.

Celgene settles Revlimid patent litigation with Natco Pharma

Generics/News | Posted 05/02/2016

Celgene Corporation (Celgene) is to provide India-based Natco Pharma and its US partner, Arrow International – a unit of Allergan – the license to manufacture and market generic Revlimid (lenalidomide) in the US from 31 January 2026, following expiration of patents in the US in April 2017. This will expedite generics competition for the drug, which currently makes up 60% of Celgene’s annual revenue.