FDA Approves Abbreviated New Drug Application for Vasopressin

Company is the first to file an ANDA referencing Vasostrict, which had total US sales of $786 million in 2020.

The FDA has approved an abbreviated new drug application from Eagle Pharmaceuticals for vasopressin, a generic alternative to Vasostrict.1

“We expect vasopressin to be a significant addition to our hospital and critical care portfolio, and we are delighted to now have final FDA approval for our A-rated, therapeutic equivalent product. We also anticipate 180-day marketing exclusivity. This is an important product for us, and a much-needed generic alternative to Vasostrict for providers and patients. We are implementing our launch plans to bring vasopressin to market,” Scott Tarriff, president and CEO of Eagle Pharma, said in a statement.1

The approval follows the August 2021 US District Court for the District of Delaware decision holding that Eagle’s proposed vasopressin product does not infringe on any patents Par Pharmaceutical Inc, or other entities, asserted against Eagle.1

In May 2018, Par sued Eagle for infringement of several patents, and the trial was held in July 2021. The court heard arguments from both entities and ruled that Par failed to meet its burden of proving Eagle’s product would not infringe on any of the asserted patent claims.2

“We are delighted with this decision,” Tarriff said in a statement in August. “This is an important step toward giving the public a generic alternative to Vasostrict. We look forward to making our vasopressin product available soon.”2

Vasoctrict is indicated to increase blood pressure in adults with vasodilatory shock, such as post-cardiotomy or sepsis, who remain hypotensive, despite catecholamines and fluids.3

Adverse reactions to Vasostrict may include bradycardia, decreased cardiac output, hyponatremia, tachyarrhythmias, and ischemia, including coronary, digital, mesenteric, and skin.3

Reference

1. Eagle Pharmaceuticals receives FDA approval for vasopressin. Business Wire. News release. December 15, 2021. Accessed December 17, 2021. https://www.businesswire.com/news/home/20211215005960/en/Eagle-Pharmaceuticals-Receives-FDA-Approval-for-Vasopressin

2. Eagle Pharmaceuticals wins vasopressin patent trial. Business Wire. News release. August 31, 2021. Accessed December 17, 2021. https://www.businesswire.com/news/home/20210831005804/en/Eagle-Pharmaceuticals-Wins-Vasopressin-Patent-Trial

3. Vasostrict (vasopressin injection). Prescribing information. Par Pharmaceutical. 2014. Accessed December 18, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204485s014lbl.pdf