Impax confirmed that Pfizer have filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging patent infringement related to Impax's filing of an Abbreviated New Drug Application (ANDA) for generic versions of Detrol LA(Tolterodine) 2mg and 4mg capsules. Impax's ANDA submission includes a Paragraph IV certification stating the Company believes its product does not infringe Pfizer's listed patents or that the listed patents are invalid or unenforceable.
following are the orange book patents listed for Tolterodine ER capsules
US5382600 (Expiry:SEP 25,2012)- Product patent
US6630162 (Expiry:MAY 11,2020)-Formulation
US6770295 (Expiry:FEB 26,2020)-Method of use and controlled release Formulation
US6911217 (Expiry:FEB 26,2020)- Controlled release formulation
Tolterodine (2-[3-[bis(1-methylethyl)amino]- 1-phenyl-propyl]-4-methyl-phenol) is an antimuscarinic drug that is used to treat urinary incontinence.
