Gland Pharma is expected to secure 180-day exclusivity for Angiotensin II Acetate.

This week, Gland Pharma received approval from the US FDA for the Angiotensin II Acetate Injection 2.5 mg/mL.

Gland Pharma's Angiotensin II Acetate Injection is a generic version of La Jolla Pharma's Giapreza. Giapreza's sales are approximately $58 million in the U.S. market for the twelve months ending March 2025.

Angiotensin II (ATII) is a naturally occurring peptide hormone that produces endocrine, autocrine, paracrine, and intracrine hormonal effects. It is a potent direct vasoconstrictor that narrows both arteries and veins, subsequently raising blood pressure.

Its half-life in circulation is approximately 30 seconds; however, in tissue, it may extend to 15-30 minutes. ATII increases the secretion of ADH and ACTH and may enhance sympathetic effects through direct actions on postganglionic sympathetic fibres. Additionally, it acts on the adrenal cortex, prompting the release of aldosterone.

Several patents are listed in OB by La Jolla Pharma’s Giapreza product. 

Product: Angiotensin II Acetate (Giapreza) Solution Eq 2.5mg Base/Ml (Eq 2.5mg Base/Ml)

Patents: listed below.

Most of these patents originate from the WO2015095535A1 patent family and were initially assigned to George Washington University. They pertain to methods of administering treatment to patients with low blood pressure.

Gland Pharma must file the P-IV certificate against most of these OB-listed patents or opt to carve out a label. These patents have been litigated. GIAPREZA is a sterile, aqueous solution of synthetic human angiotensin II for intravenous administration by infusion. Each 1 mL of GIAPREZA contains 2.5 mg of angiotensin II, which is equivalent to an average of 2.9 mg of angiotensin II acetate. It also contains 25 mg of mannitol and Water for Injection, adjusted with sodium hydroxide and/or hydrochloric acid to a pH of 5.5. The chemical name of the synthetic angiotensin II acetate is L-Aspartyl-L-arginyl-L-valyl-Ltyrosyl-L-isoleucyl-L-histidyl-L-prolyl-L-phenylalanine, acetate salt. The counter ion acetate is present in a non-stoichiometric ratio. It is a white to off-white powder, soluble in water.

The structure of angiotensin II acetate is shown below.

Gland could have imported this peptide from BCN Peptides in Spain at €10000/kg and used it in exhibit batches for US FDA approval. Gland could have submitted the ANDA in December 2021. Gland Pharma has secured first-to-file status and is entitled to 180-day exclusivity. This exclusivity ensures that Gland Pharma will be the sole supplier of this product during this period, giving it an advantageous position over the competition for the 2.5 mg/mL strength. The settlement date will determine the launch. Fresenius Kabi likely resolved the case alongside Gland.