Bivalirudin Injection Shortage

• • Bivalirudin lyophilized powder for injection, Accord, 250 mg, vial, 10 count, NDC 16729-0275-67
  • Bivalirudin lyophilized powder for injection, Eugia US, 250 mg, vial, 10 count, NDC 55150-0210-10
  • Bivalirudin lyophilized powder for injection, Mylan (Viatris), 250 mg, vial, 10 count, NDC 67457-0256-10
  • Bivalirudin solution for injection, Par Pharmaceuticals, ready-to-use 250 mg/50 mL, vial, 10 count, NDC 42023-0622-10
  • Bivalirudin lyophilized powder for injection, Pfizer, 250 mg, ADD-Vantage vial, 10 count, NDC 00409-8300-15 - discontinued
  • Bivalirudin lyophilized powder for injection, Sagent, 250 mg, vial, 10 count, NDC 70860-0402-10 - discontinued
  • Bivalirudin lyophilized powder for injection, Sandoz, 250 mg, vial, 10 count, NDC 00781-3158-95

• • Accord has temporarily discontinued bivalirudin injection.
  • Avenacy has bivalirudin injection available.
  • Dr. Reddy's has bivalirudin injection available.
  • Eugia did not provide a reason for the shortage.
  • Pfizer discontinued bivalirudin 250 mg ADD-Vantage vials in early-2024.
  • Meitheal has bivalirudin injection available.
  • Fresenius Kabi has bivalirudin injection available.
  • Par (Endo) has bivalirudin ready-to-use vials on shortage due to increased demand.
  • Sagent discontinued bivalirudin injection in early-2025.
  • Sandoz did not provide a reason for the shortage.
  • Slate Run has bivalirudin injection available.
  • Viatris did not provide a reason for the shortage.

• • Bivalirudin lyophilized powder for injection, Avenacy, 250 mg, vial, 10 count, NDC 83634-0400-10
  • Bivalirudin lyophilized powder for injection, Dr. Reddy's, 250 mg, vial, 10 count, NDC 55111-0652-37
  • Bivalirudin lyophilized powder for injection, Fresenius Kabi, 250 mg, vial, 10 count, NDC 63323-0562-10
  • Bivalirudin lyophilized powder for injection, Meitheal Pharmaceuticals, 250 mg, vial, 10 count, NDC 71288-0427-11
  • Bivalirudin lyophilized powder for injection, Slate Run Pharmaceuticals, 250 mg, vial, 10 count, NDC 70436-0025-82

Estimated Resupply Dates

• • Accord has temporarily discontinued bivalirudin 250 mg vials and the company cannot estimate a release date.
  • Eugia has bivalirudin 250 mg vials on intermittent back order and the company is releasing supplies as they become available.
  • Par has bivalirudin 250 mg/50 mL ready-to-use vials on back order and the company estimates a release date in mid-May 2025.
  • Sandoz has bivalirudin 250 mg vials on back order and the company cannot estimate a release date.
  • Viatris has bivalirudin 250 mg vials on back order and the company estimates a release date of mid- to late-June 2025.