Endo International (ENDPQ) Launches Colchicine Capsules

Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE^®. This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.

"We are pleased to offer this high-quality, affordable medication," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "As a reliable supplier of generic products, we take pride in providing choices to appropriate patients."

Colchicine capsules are indicated for prophylaxis of gout flares in adults.

According to IQVIA^™, colchicine capsules sales were approximately $65.4 million for the 12 months ended September 30, 2023.

MITIGARE^® is a registered trademark of Hikma Pharmaceuticals USA, Inc.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.
Patients with both renal and hepatic impairment should not be given colchicine.

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