Generics/News
Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity
US-based Mylan has sued FDA for refusing to grant approval to sell a generic version of Novartis’s heart treatment, Diovan HCT (valsartan/hydrochlorothiazide), ‘after a competitor failed to get the drug on the market in time’.
Teva withdraws generic antidepressant from US
Israel-based Teva Pharmaceutical Industries (Teva), the world’s largest generics manufacturer, has removed its Budeprion XL 300 mg generic version of GlaxoSmithKline’s antidepressant Wellbutrin XL (bupropion) from the US market after regulators said it is not therapeutically equivalent to Wellbutrin XL 300 mg.
Mylan debuts first generic Diovan HCT and Antivert in USA
Mylan is first off the mark once again with its latest generics launch. Mylan announced on 21 September 2012 that its subsidiary Mylan Pharmaceuticals has received final approval from FDA for its Abbreviated New Drug Application (ANDA) for valsartan/hydrochlorothiazide tablets USP.
Bayer loses Nexavar compulsory licence appeal
Bayer has lost its appeal to the Indian Government’s decision to grant a compulsory licence for its cancer drug Nexavar (sorafenib).
Hospira acquires manufacturing, R & D facilities in India
On 29 August 2012, US-based Hospira announced an agreement to acquire an API (active pharmaceutical ingredient) manufacturing facility, together with an associated research and development (R & D) facility, from Orchid Chemicals & Pharmaceuticals. The modern, FDA-approved facility is costing approximately US$200 million. Acquisition of this leading Indian pharmaceuticals company is expected to reduce Hospira’s costs, support continuity of supply of key antibiotic products and pave the way for future API development [1].
Mylan generics launches in the US
Mylan has 166 abbreviated new drug applications (ANDAs) pending Food and Drug Administration approval representing US$78.4 (Euros 61.3) billion in annual sales. Thirty-five of these are potential first-to-file opportunities, representing US$25.1 (Euros 19.6) billion in annual brand sales (2011 IMS Health figures).
Impax settles patent dispute with Genzyme
Impax Laboratories (Impax) announced on 4 September 2012 that it had reached an agreement with Sanofi subsidiary, Genzyme Corporation (Genzyme), to settle pending US litigation with regard to the production and sale of generic versions of Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride).
Injectables may be next on Big Pharma shopping list
The injectables division of Indian pharmaceutical company Strides Arcolab (Strides), known as Agila, is becoming an increasingly attractive potential acquisition for Big Pharma who are looking to expand their portfolios. Strides, based in Bangalore, may already be considering selling Agila, which produces a range of injectable generic medicines for the treatment of cancer and infections, with Pfizer as one possible purchaser.
Pfizer reaches agreement with Impax over generic Detrol
Pfizer has reached an agreement with Impax Laboratories (Impax) over the production and marketing of a generic drug alternative to the bladder-control treatment Detrol LA (tolterodine tartrate). The two companies have ‘settled a patent lawsuit’ based on a licence agreement dated 16 August 2012 that prohibits Impax from selling generic versions of Detrol LA ‘except as permitted under the settlement and license agreement.’
Wockhardt gains approvals for ‘steady stream’ of generics
Wockhardt has won FDA approval for four generics products in a matter of days. On 16 August 2012, the India-based company announced the final approval and immediate product launch of the anti-blood clotting drug clopidogrel bisulfate in 75 mg tablet form, and tentative approval for 300 mg-containing tablets.
