Mallinckrodt files lawsuit against Watson Laboratories
Mallinckrodt has filed a lawsuit against Watson Laboratories, subsidiary of Watson Pharmaceuticals, in the US District Court for the District of New Jersey seeking to prevent Watson from commercializing Exalgo’s generic version prior to the expiration of Hydromorphone Hydrochloride extended-release tablets, 8mg, 12mg, and 16mg (US patent no 5,914,131).
Hydromorphone Hydrochloride extended-release tablets are a generic version of Mallinckrodt’s Exalgo tablets, which are indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
Dihydromorphinone and dimorphone, commonly a hydrochloride (trade names Palladone, Dilaudid, and numerous others) is a potent centrally-acting analgesic drug of the opioid class. It is a derivative of morphine, to be specific, a hydrogenated ketone thereof and, therefore, a semi-synthetic drug.
The dosage of opioid analgesics like hydromorphone hydrochloride should be individualized for any given patient, since adverse events can occur at doses that may not provide complete freedom from pain.
Safe and effective administration of opioid analgesics to patients with acute or chronic pain depends upon a comprehensive assessment of the patient. The nature of the pain (severity, frequency, etiology, and pathophysiology) as well as the concurrent medical status of the patient will affect selection of the starting dosage.
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