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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.

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FDA approval for generic diabetes drug Actos

Generics/News | Posted 24/08/2012

On 17 August 2012, FDA gave final approval to Mylan Pharmaceuticals for the first generic version of Actos (pioglitazone hydrochloride tablets), for the treatment of type 2 diabetes. The approval covers tablets containing 15 mg, 30 mg and 45 mg pioglitazone.

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Court upholds decision against AstraZeneca’s omeprazole

Generics/News | Posted 10/08/2010

On 1 July 2010, the General Court of the European Union (GCEU) upheld the decision of the European Commission (EC), which found that AstraZeneca had abused its dominant position by preventing the marketing of generic versions of Losec (omeprazole).

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Gilead makes HIV generics deal

Generics/News | Posted 17/08/2012

US-based drugmaker Gilead Sciences (Gilead) announced on 2 August 2012 a new collaboration with Indian generics manufacturers to provide low cost HIV medicine to developing countries.

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Ranbaxy forfeits exclusivity on generic Provigil

Generics/News | Posted 17/08/2012

As part of Ranbaxy’s consent decree with FDA, signed in January 2012, the Indian generics major had to agree to relinquish 180-day marketing exclusivity on three pending generic drug applications [1]. Now analysts believe that generic Provigil (modafinil) may have been one of those undisclosed drugs.

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FDA approves generics of Merck’s Singulair

Generics/News | Posted 10/08/2012

FDA announced on 3 August 2012 that the agency had approved not one, but ten generic versions of Merck’s blockbuster asthma-allergy drug Singulair (montelukast).

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Pfizer wins against generic versions of pain drug Lyrica

Generics/News | Posted 03/08/2012

The world’s largest drugmaker Pfizer has successfully blocked Israel-based Teva Pharmaceutical Industries (Teva) and other manufacturers from selling generic versions of its fibromyalgia treatment Lyrica (pregabalin) until patents on the drug expire in 2018. The ruling, announced on 19 July 2012, was the result of a lawsuit begun in 2009 contending that sales of generic Lyrica would infringe Pfizer’s patents and cause irreparable harm to sales.

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Watson gains FDA approval for morning after pill

Generics/News | Posted 03/08/2012

US generics company Watson Pharmaceuticals (Watson) announced on 13 July 2012 that its subsidiary Watson Laboratories, has received approval from FDA for its Abbreviated New Drug Application (ANDA) for Next Choice One Dose (levonorgestrel tablet, 1.5 mg), the generic equivalent to Teva Women’s Health’s Plan B One-Step. Watson plans to launch the product immediately.

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More downs than ups for Ranbaxy

Generics/News | Posted 29/06/2012

A further problem with Indian generics manufacturer Ranbaxy Laboratories (Ranbaxy) could affect its reputation yet again with US FDA. This time, Ranbaxy fell foul of an Indian state regulator, the Maharashtra FDA (FDA, Maharashtra State, India). The Indian crack-down on Ranbaxy follows in the wake of a consent decree issued by US FDA in January 2012 which tightens scrutiny of Ranbaxy’s quality control and reporting measures.