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Watson settles Lidoderm patent dispute with Endo

Watson can now bring its generic version of the post-shingles pain patch to US market two years early

Watson Pharmaceuticals

Watson Pharmaceuticals has settled a US lawsuit brought by Endo that sought to block Watson's generic version of pain medication Lidoderm from coming to market before its patent expired.

Under the agreement, Watson will be allowed to launch an authorised generic of the lidocaine patch for post-shingles pain on September 15, 2013 – two years ahead of US patent expiry – if the product is approved by the Food and Drug Administration (FDA).

In return, Endo will receive 25 per cent of the gross profit from Watson's sales of its generic version of Lidoderm up until the 2015 patent expiry. This will help Endo mitigate the anticipated impact a rival product would have on its pain drug, which had US sales of $1.2bn for the twelve months to March 31, 2012.

The settlement also gives Watson the right to receive and distribute equal amounts of Endo's branded Lidoderm, up to a total value of up to $96m, until September 15, 2013.

“By entering into this agreement, Watson ensures that consumers may benefit from generic competition at least two years prior to the 2015 patent expiry on Lidoderm assuming FDA approval,” said Watson's president and CEO Paul Bisaro.

If Watson fails to gain FDA approval for its own lidocaine patch by January, 2014, Endo will continue to provide the company with more of its own branded Lidoderm up to a value of $80m during 2014.

Similar, if no FDA approval is given to a generic from Watson by January, 2015, Endo will provide up to $64m worth of its own product.

Once another generic product is launched following the 2015 patent expiry, however, Watson will no longer be eligible to receive branded Lidoderm from Endo.

31st May 2012

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