22 Zidovudine patent challenge extends to the US MARKET NEWS Novopharm has filed an abbreviated NDA for generic zidovudine and has plans to challenge Wellcome's patent for the use of zidovudine ('Retrovir') for the treatment of AIDS. Novopharm maintains that the use of zidovudine for this condition was discovered by researchers at the National Institutes of Health, not by Wellcome, and that this information was omitted in Wellcome's patent filings. Another US company, Barr Laboratories, has already filed an ANDA for a generic zidovudine and is also challenging Wellcome's patent. Canada approves Novopharm has already received approval for its generic, 'Novo-AZT'. Apotex was the first company to receive approval for a generic zidovudine and, together with Novopharm, is challenging the validity of Wellcome's patent in the Canadian federal court. Both companies plan to market their products in countries where 'Retrovir' has no patent protection. Generic zidovudine in Brazil Although zidovudine is covered by Wellcome's international patents, Brazil has so far not accepted pharmaceutical product patents. And although Brazilian patent laws are currently under review, the legislation is not retroactive and will not benefit Wellcome. Taking advantage of these conditions, Brazilian manufacturer, Microbiologica, has received approval from local authorities to produce a generic version of zidovudine. The lastest development is that Microbiologica is to commence sales of its generic product in syrup form (mainly for children), putting further pressure on Wellcome. HOOIS6JI2 12 Sep 1992 ISSN 0156-2703/9210912-00221$1.00© Adls International Ltd

Zidovudine patent challenge extends to the US

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Zidovudine patent challenge extends to the US

MARKET NEWS

Novopharm has filed an abbreviated NDA for generic zidovudine and has plans to challenge Wellcome's patent for the use of zidovudine ('Retrovir') for the treatment of AIDS.

Novopharm maintains that the use of zidovudine for this condition was discovered by researchers at the National Institutes of Health, not by Wellcome, and that this information was omitted in Wellcome's patent filings. Another US company, Barr Laboratories, has already filed an ANDA for a generic zidovudine and is also challenging Wellcome's patent.

Canada approves ~ Novopharm has already received approval for its

generic, 'Novo-AZT'. Apotex was the first company to receive approval for a generic zidovudine and, together with Novopharm, is challenging the validity of Wellcome's patent in the Canadian federal court. Both companies plan to market their products in countries where 'Retrovir' has no patent protection.

Generic zidovudine in Brazil Although zidovudine is covered by Wellcome's

international patents, Brazil has so far not accepted pharmaceutical product patents. And although Brazilian patent laws are currently under review, the legislation is not retroactive and will not benefit Wellcome.

Taking advantage of these conditions, Brazilian manufacturer, Microbiologica, has received approval from local authorities to produce a generic version of zidovudine. The lastest development is that Microbiologica is to commence sales of its generic product in syrup form (mainly for children), putting further pressure on Wellcome.

HOOIS6JI2

12 Sep 1992 INPHARMA~ ISSN 0156-2703/9210912-00221$1.00© Adls International Ltd