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First prequalification submissions for generic dolutegravir Posted 25/11/2016

The Medicines Patent Pool (MPP) announced on 10 November 2016 that two of its generics manufacturing partners are the first companies to apply for prequalification of generic dolutegravir, a new antiretroviral that the MPP licensed from ViiV Healthcare in 2014.

India-based generics maker Cipla and US generics maker Mylan have applied to the World Health Organization (WHO) for prequalification of generic versions of the 50 mg tablet of dolutegravir. The MPP also notes that nine other MPP licensees are also developing dolutegravir and therefore further submissions to either WHO or US Food and Drug Administration (FDA) are expected soon.

The news is seen as an important development in the fight against HIV/AIDS. Dolutegravir was recently recommended as an alternative first-line treatment by WHO. The drug is considered a significant improvement in antiretroviral therapy, as the treatment does not require boosting and has a good barrier to resistance, as well as high efficacy and tolerability at a relatively low dose.

ViiV Healthcare granted the MPP two non-exclusive licences for the generics manufacture of dolutegravir. One licence covers the production of the medicine for adults and the other covers children. Both licences allow generics makers based anywhere in the world to manufacture dolutegravir and to combine the treatment with other drugs to develop fixed-dose combinations of regimens recommended by WHO. In the spring of 2016, the two parties extended the adult licence to all lower middle-income countries, allowing sale of generic dolutegravir in more than 130 countries.

ViiV Healthcare is also facilitating applications for Tentative Approval by FDA for dolutegravir products manufactured by MPP generics partners by waiving its right to a five-year new chemical entity (NCE) exclusivity period for dolutegravir.

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Source: MPP, Mylan

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