Generics/News
FDA approves first generic rosuvastatin
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
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
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
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
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
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
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
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
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
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.
