The pros and cons of authorized generics

4 September 2009

While the benefits of authorized generics to the branded industry are clearly apparent, the attitude of the generics industry is determined by individual company strategy, according to a new report from Datamonitor, titled Generics Series: Authorized Generics Analysis. For those generics players that aggressively challenge patents, authorized generics are a threat to revenues, while for other smaller companies, authorized generics represent an opportunity to get to market quickly and easily.

Given the benefits associated with own authorized generics, it is unsurprising that these dominated the data-set under investigation, with the Pfizer-Greenstone authorized generic combination by far the most frequent, it says.
The authorized generic launched at a greater discount to the branded drug than the conventional copy drugs, in 65% of agreements under analysis, reflecting the higher margins available to the authorized generics company which potentially neither developed, manufactured, or obtained approval to market the drug.

The greatest number of generic entrants was associated with the highest value branded products (with pre-generic quarterly sales in excess of $600 million) in the data-set under analysis, with this group showing an average of 14 and 19 competitors at one and two years post generics launch, the report notes.

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