Generics

Bill introduced to ensure generics get 180-day exclusivity

Congressman Frank Pallone and Congressman Brett Guthrie introduced a new bill to the US Senate on 29 March 2012 to amend the US Food, Drug and Cosmetic Act in order to ensure that generics manufacturers get their 180-day exclusivity.

Novartis introduces branded generic tacrolimus

Novartis announced on 3 April 2012 that it had launched a branded generic version of Astellas Pharma’s immunosuppressant Prograf (tacrolimus).

Also noted on generics: 6 April 2012

Tropsium XR patents declared invalid
Watson Pharmaceuticals confirmed in early April 2012 that the United States District Court for the District of Delaware has ruled that four patents for Sanctura XR (trospium chloride extended-release capsules) are invalid. Watson’s Abbreviated New Drug Application for a generic version of the overactive bladder treatment is pending with FDA.

According to IMS Health data Sanctura XR had US sales of approximately US$68 million for the twelve months ending 29 February 2012.

Source: Watson

AstraZeneca losing fight against generic quetiapine

AstraZeneca’s is losing the fight it seems to protect its blockbuster antipsychotic drug Seroquel (quetiapine fumarate).

Attitudes towards prescribing generics in Malaysia

A recent study carried out in Malaysia has shown that pharmacists in the country have a lack of confidence in generic medicines produced by local pharmaceutical companies [1].

FDA approves first generic ibandronate sodium osteoporosis drugs

FDA announced on 19 March 2012 the approval of the first generics of GlaxoSmithKline’s and Roche’s postmenopausal osteoporosis drug Boniva (ibandronate sodium).

Also noted on generics: 30 March 2012

Watson in talks to buy Actavis
US generics manufacturer Watson is rumoured to be making a bid for Icelandic generics company Actavis, according to Bloomberg, creating one of the world’s largest generics companies in the process. Watson is reportedly in private talks to pay around Euros 4.5 billion for Actavis, with a deal likely to be announced after Easter.

Source: Bloomberg

Generic rosuvastatin approved in Canada

Generics giant Mylan Pharmaceuticals (Mylan) announced on 15 March 2012 that it had received approval from Health Canada for a generic version of AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin). The approval covers tablets in 5, 10, 20 and 40 mg strengths.

Brand-name atorvastatin cheaper than generics

Despite generics of Pfizer’s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) being available in the US since the patent expired in November 2011, many patients are still receiving the brand-name drug [1].

AstraZeneca sues FDA over generic quetiapine

In an attempt to prevent competition from generics to its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate), pharma giant AstraZeneca has filed a lawsuit against FDA.