Para-IV challenge for Pramipexole 2 HCl: U.S. District Court favors Barr Pharma.

June 26, 2008 : Barr Pharmaceuticals have announced favorable opinion by U.S. District Court for Delaware in it’s favor pertaining to a Para-IV challenge filed for Mirapex (R) i.e. Pramipexole dihydrochloride, the court have ruled the OB listed patents US 4,886,812 as Invalid on the grounds of nonstatutory double patenting.

Pramipexole (INN, trade names Mirapex and Sifrol) is a medication indicated for treating Parkinson's disease and restless legs syndrome (RLS). It is also sometimes used off-label as a treatment for cluster headache or to counteract the problems with low libido experienced by some users of SSRI antidepressant drugs. Pramipexole has shown robust effects on pilot studies in a placebo-controlled proof of concept study in bipolar disorder[1]. Pramipexole is classified as a non-ergoline dopamine agonist.

Source: http://www.rxtimes.com/?p=1633
http://www.bloomberg.com/

Lansoprazole Patent Challenge

Ethypharm, Takeda & TAP Pharmaceuticals together sue Barr Pharmaceuticals for Prevacid.
June 11, 2008

Barr Confirms Patent Challenge of Prevacid(R) SoluTab(TM) Delayed-Release Orally Disintegrating Tablets, 15mg and 30mg

MONTVALE, N.J., June 10 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid(R) SoluTab(TM) Delayed-Release Orally Disintegrating Tablets (lansoprazole), 15mg and 30mg.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Prevacid SoluTab product with the U.S. Food & Drug Administration (FDA) in November 2007. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.

On June 9, 2008, Ethypharm, S.A., Takeda Pharmaceutical Co., Ltd. and TAP Pharmaceuticals Inc. filed suits in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Prevacid SoluTab (lansoprazole) had annual sales of approximately $428 million in the U.S., based on IMS sales data for the 12-month period ending March 2008.

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