Amneal Expands Injectables Portfolio with 4 New Products

Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the approval of four generic injectables products. Dexamethasone sodium phosphate injection, USP 10 mg/mL, azacitidine 100 mg, carboprost tromethamine injection, USP 250 mcg/mL, and atropine sulfate injection, USP 0.5 mg/5 mL, have received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA). Dexamethasone and azacitidine are both currently on the FDA drug shortage list, and atroprine was granted Competitive Generic Therapy (CGT) status by the FDA.

The Company has approximately 25 commercial injectables for the U.S. institutional market and is targeting over 40 launches from 2021 to 2025 in a variety of complex areas, such as drug/device combinations, peptides, long acting injectables and large volume parenteral (LVP) bags.

“An important element of Amneal’s long-term growth strategy is expanding our injectables business, and today’s announcement of four new approvals is another key step. We look to scale our injectables business through new products and by leveraging our recent Puniska and Saol baclofen franchise acquisitions towards our goal of being top five in the U.S. institutional injectables market and a global player over time,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “These four approvals, including two products currently on the FDA drug shortage list, demonstrate our commitment to the institutional market and to alleviating drug shortages so that patients can have access to the medicines they need,” said Harsher Singh, SVP for Amneal Biosciences.

Dexamethasone is a bioequivalent and therapeutically equivalent generic to the reference standard dexamethasone sodium phosphate injection, USP 10 mg/mL. This corticosteroid is currently on the FDA drug shortage list. According to IQVIA®, U.S. annual sales for dexamethasone injection for the 12 months ended December 2021 were $66 million.

For full prescribing information, see package insert located here.

Azactidine is the generic equivalent for Vidaza® Injection 100 mg. This antineoplastic drug is currently on the FDA drug shortage list. According to IQVIA®, U.S. annual sales for azacitidine injection for the 12 months ended December 2021 were $61 million.

For full prescribing information, see package insert located here.

Carboprost is a generic version of the prostaglandin Hemabate® Injection, 250 mcg/mL. According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2021 were $57 million.

For full prescribing information, see package insert located here.

Atropine is an anticholinergic agent. It is a bioequivalent and therapeutically equivalent generic to the reference listed drug atropine sulfate injection, USP, 0.5 mg/5 mL in a pre-filled single-dose syringe. This product was granted CGT status. According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2021 were $1 million.

For full prescribing information, see package insert located here.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.