Wockhardt gains approvals for ‘steady stream’ of generics

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Wockhardt gains approvals for ‘steady stream’ of generics

Generics/News | Posted 07/09/2012 0 Post your comment

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.

Plavix is the brand name for the originator drug produced by Bristol-Myers Squibb. The total market for this product in the US was over US$6,500 million, according to IMS Health.

On 20 August 2012, FDA granted Wockhardt marketing approval for a generic version of entacapone (200 mg tablets) for the treatment of Parkinson’s disease.

‘Pursuant to a settlement of the litigation between Wockhardt and Orion Corporation, Finland, the holder of the NDA (New Drug Application), Wockhardt will launch an authorised generic version from 30 September 2012, with 180-days of exclusivity’, said Wockhardt Founder Chairman and Group CEO Dr Habil Khorakiwala in a press release.

Entacapone is the generic version of Orion’s product Comtan, which in the US is marketed by Novartis. IMS Health estimates the total market for entacapone tablets in the US to be around US$98 million, reports Business Standard.

Then on 21 and 22 August 2012, the company received the go-ahead to market generic versions of the antipsychotic Geodon (ziprasidone) produced by Pfizer, and the antihypertensive Plendil (felodipine) produced by Astra Zeneca.

‘Wockhardt’s R & D has ensured a steady stream of new products which has translated into a varied product offering in US markets’, Dr Khorakiwala said in a press release. ‘In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant’, he added.

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Source: Wockhardt