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Generics/News

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Watson buys women’s health company Uteron

Generics/News | Posted 08/02/2013

Generics giant Watson Pharmaceuticals, now known as Actavis, announced on 23 January 2013 that it has completed the acquisition of Belgium-based Uteron Pharma for US$150 million in cash up front, and up to US$155 million in potential future milestone payments.

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First generic versions of Duetact and Maxalt approved

Generics/News | Posted 01/02/2013

First-to-file generics from Mylan and Sandoz have been approved by FDA for rizatriptan benzoate and pioglitazone hydrochloride/glimepiride tablets, respectively.

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Watson becomes Actavis

Generics/News | Posted 01/02/2013

Watson Pharmaceuticals announced on 24 January 2013 that the company had officially adopted Actavis as its new global name under which it will now trade on the New York Stock Exchange.

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Pharmascience and Kolmar to create Korean generics joint venture

Generics/News | Posted 24/01/2013

Canadian generics maker Pharmascience and Korea-based Kolmar Holdings (Kolmar) announced on 2 January 2013 that they had entered into an agreement to create a new joint venture, Pharmascience Korea, for the marketing of Canadian-made bioequivalent medicines.

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Watson submits ANDA for generic cancer drug

Generics/News | Posted 18/01/2013

Watson Pharmaceuticals confirmed on 28 December 2012 that Actavis, which was acquired by Watson in October 2012, has filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market generic bortezomib. Actavis’ ANDA product is a generic version of Millennium Pharmaceuticals’ (Millennium) cancer drug Velcade (bortezomib).

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Ranbaxy not the only Indian generics maker subject to FDA recalls

Generics/News | Posted 07/12/2012

It seems that Ranbaxy Pharmaceuticals (Ranbaxy) is not the only Indian generics manufacturer who has been subjected to FDA recalls. It now comes to light that Dr Reddy’s Laboratories (Dr Reddy’s) and Aurobindo Pharma (Aurobindo) have also had to recall key generic drugs during 2012.

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Ranbaxy recalls generic atorvastatin in US

Generics/News | Posted 30/11/2012

Ranbaxy Pharmaceuticals (Ranbaxy) has fallen foul of FDA once again. The Indian generics major announced on its US website that it is conducting a voluntary recall for certain batches of its atorvastatin calcium tablets, a generic version of Pfizer’s blockbuster cholesterol-reducing drug Lipitor.

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Generics competition for Pfizer’s sildenafil

Generics/News | Posted 23/11/2012

Apotex Corporation, Dr Reddy’s Laboratories, Mylan, Torrent Pharmaceuticals and Watson Laboratories have all received FDA approval for bioequivalent generic versions of Pfizer’s Revatio (sildenafil citrate – Viagra in Europe) in the US market following the approval by FDA of the generics companies abbreviated new drug applications (ANDAs) for sildenafil tablets.

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German court rules Seroquel XR patent invalid

Generics/News | Posted 16/11/2012

AstraZeneca has lost another battle to protect its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) against generics.

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FDA ordered to let Watson sell generic Actos

Generics/News | Posted 09/11/2012

Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered FDA to approve Watson’s generic pioglitazone against the agency’s decision to bar Watson during the first six months of generics availability.

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Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity

Generics/News | Posted 26/10/2012

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’.

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Teva withdraws generic antidepressant from US

Generics/News | Posted 19/10/2012

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.

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Mylan debuts first generic Diovan HCT and Antivert in USA

Generics/News | Posted 12/10/2012

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.

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Bayer loses Nexavar compulsory licence appeal

Generics/News | Posted 05/10/2012

Bayer has lost its appeal to the Indian Government’s decision to grant a compulsory licence for its cancer drug Nexavar (sorafenib).

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Hospira acquires manufacturing, R & D facilities in India

Generics/News | Posted 21/09/2012

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].

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Mylan generics launches in the US

Generics/News | Posted 14/09/2012

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).

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Impax settles patent dispute with Genzyme

Generics/News | Posted 14/09/2012

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).

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Injectables may be next on Big Pharma shopping list

Generics/News | Posted 07/09/2012

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.

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Pfizer reaches agreement with Impax over generic Detrol

Generics/News | Posted 07/09/2012

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.’

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Wockhardt gains approvals for ‘steady stream’ of generics

Generics/News | Posted 07/09/2012

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.