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Agreements

Date: 2014-07-02

Type of information: Product acquisition

Compound: ursodiol tablet, lamotrigine orally disintegrating tablet (ODT)

Company: Impax Laboratories (USA - CA), Actavis (Ireland)

Therapeutic area: Liver diseases - CNS diseases

Type agreement:

product acquisition

Action mechanism:

Disease: primary biliary cirrhosis

Details:

* On July 2, 2014, Impax Laboratories announced that it has acquired from Actavis plc two generic products for cash consideration pursuant to a Purchase Agreement and a Supply Agreement. The acquisition includes one product marketed under an Abbreviated New Drug Application (ANDA) - Ursodiol tablet - and one approved ANDA that is not yet marketed - Lamotrigine orally disintegrating tablet (ODT). These products are two of the four generic products that Actavis and Forest Laboratories have agreed to sell or relinquish their rights under the Federal Trade Commission's proposed settlement. Actavis is in the process of acquiring Forrest Laboratories and the FTC has noticed that this acquisition would violate federal antitrust laws by reducing competition in generic diltiazem hydrochloride extended release capsules used to treat hypertension and chronic stable angina; generic ursodiol tablets used to treat primary biliary cirrhosis of the liver; and generic propranolol hydrochloride extended release capsules used to treat hypertension. Under FTC's proposed settlement order, Actavis and Forest have agreed to sell generic ursodiol and generic lamotrigine ODT to Impax Laboratories.

Financial terms:

Financial terms of the agreement were not disclosed.

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Is general: Yes