Pfizer and Mylan settle patent lawsuit over Detrol LA

Hannah Blake

pharmaphorum

Global pharmaceutical company Pfizer has announced that it has settled its litigation against Mylan Pharmaceuticals relating to Pfizer’s patents covering Detrol LA (tolterodine tartrate) extended-release capsules. This lawsuit was in connection with Mylan’s Abbreviated New Drug Application (ANDA) for Tolterodine Tartrate ER capsules, 2 mg and 4mg.

Tolterodine tartrate is for the treatment of patients with an overactive bladder who have symptoms of urge urinary incontinence, urgency, and frequency.

As a result of this settlement, Pfizer expects generic competition for Detrol LA in the United States between January 1st and March 1st, 2014. Under terms of the agreement between Pfizer and Mylan, Mylan may launch its generic version of Detrol LA either as an authorized generic or under its own ANDA.

The FDA has not approved a generic version of Detrol LA to date.

EU-Clinical-Trial-Directive-Regulatory-Requirements-20Sep12

Related news:

Mylan will launch generic Detrol LA in 2014 (Bloomberg Businessweek)

Mylan, Pfizer settle patent suit on generic Detrol LA (Reuters)

Reference links:

Pfizer

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