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Fiorinal

Novartis AG

Drug Names(s): Butalbital, aspirin, caffeine, USP

Description: Fiorinal combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital.

Aspirin
The analgesic activity of aspirin is due to its ability to inhibit cyclooxygenase (COX). Aspirin is mainly hydrolyzed to salicylicacid and distributed to all body tissues and fluids, including fetal tissues, breast milk, and thecentral nervous system (CNS). Highest concentrations are found in plasma, liver, renal cortex,heart, and lung. The biotransformation of aspirin occurs primarily in the hepatocytes.

Butalbital
The sedative-hypnotic effects of butalbital result from producing or enhancing the inhibitory affects of gamma-aminobutyric acid (GABA) in the thalamus. Barbiturates inhibit ascending conduction in the reticular formation, which interferes with conduction of impulses to the cortex causing sensory cortex depression, decreased motor activity, drowsiness, sedation, and changes in cerebral function.Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to mostof the tissues in the body.

Caffeine
Caffeine causes cerebral vasoconstriction, which decreases blood flow and oxygen tension. Caffeine may provide a quicker onset of action and enhance pain relief allowing for lower doses of analgesics when taken in combination with aspirin. In some patients, caffeine relieves headaches by treating the effects of caffeine withdrawal.

Deal Structure: Novartis and Watson
On February 6, 2003, Novartis announced the completed sale of the US rights to its Fioricet andFiorinal lines to Watson Pharmaceuticals for USD 178 million.

Novartis and Paladin Labs
On March 2, 2001, Paladin Labs signed an agreement with Novartis Pharmaceuticals Canada for the exclusive Canadian marketing and distribution rights to Fiorinal and Fiorinal-C. Terms of the agreement were not disclosed.

In January 2013, Watson changed its name to Actavis.

Novartis and Tribute
In October 2014, Tribute Pharmaceuticals announced that it has acquired the Canadian rights to Fiorinal, Fiorinal C, Visken and Viskazide (the Products) from Novartis for CDN $32 million which was paid in cash on closing. The Company funded the acquisition of the Products with cash on hand and with US$6 million of debt provided by SWK Holdings Corporation.

Tribute and POZEN
In June 2015, POZEN announced the acquisition of...See full deal structure in Biomedtracker

Partners: Allergan plc Aralez Pharmaceuticals Inc.


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