Zydus, CHEMI collaborate to launch generic equivalent of Lovenox in US

Ahmedabad: Zydus Pharmaceuticals Inc, USA, a 100% subsidiary of Cadila Healthcare Limited, has signed a license and supply agreement with CHEMI SpA of Italy, a subsidiary of Italfarmaco Group, to launch the generic equivalent of Sanofi Aventis's branded product Lovenox (Enoxaparin Sodium Injection) in seven dosage strengths in the United States (US).

Under the agreement, CHEMI will manufacture and supply the Enoxaparin Sodium Injection which Zydus will commercialize in the US. CHEMI owns proprietary rights on a pharmaceutical product composed of Enoxaparin Sodium (Preservative Free) single-use pre-filled syringes, which is an APrated generic version of the branded product Lovenox. CHEMI, utilizing their proprietary technology, will produce the Enoxaparin Sodium injection within proprietary manufacturing facilities located in Italy. 

"CHEMI within ITF group is also vertically integrated on the Enoxaparin Sodium API manufacturing which ensures quality and an uninterrupted supply of the critical care product," the release said.

Speaking on the development, Managing Director of Cadila Healthcare Limited, Dr. Sharvil Patel said, "This partnership between Zydus and CHEMI is another step in our unwavering commitment to improving the supply of critical care drugs, which are vital in delivering quality patient care. In addition, this collaboration will bolster the Zydus injectable portfolio and demonstrates Zydus' long-term commitment to drive growth through investment in complex generic products. We're proud to be the first Indian company to launch a generic version of Enoxaparin in the United States and are excited about this opportunity."

Enoxaparin Sodium Injection, USP is used for prophylaxis of Deep Vein Thrombosis (DVT) in patients undergoing abdominal, hip or knee replacement surgery, and also for the treatment of acute DVT. Enoxaparin acts as blood thinner by producing an antithrombotic effect.

Enoxaparin Injection had annual sales of approximately $513 million in the United States, according to IQVIA data as of June 2021.

Read also: Zydus Cadila COVID vaccine recommended for EUA by CDSCO panel