Products Affected - Description

• • Bivalirudin lyophilized powder for injection, Accord, 250 mg, vial, 10 count, NDC 16729-0275-67
  • Bivalirudin lyophilized powder for injection, Avenacy, 250 mg, vial, 10 count, NDC 83634-0400-10
  • Bivalirudin solution for injection, Par Pharmaceuticals, ready-to-use 250 mg/50 mL, vial, 10 count, NDC 42023-0622-10

Reason for the Shortage

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

Available Products

• • 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, Mylan (Viatris), 250 mg, vial, 10 count, NDC 67457-0256-10
  • Bivalirudin lyophilized powder for injection, Sandoz, 250 mg, vial, 10 count, NDC 00781-3158-95

• • Accord has temporarily discontinued bivalirudin 250 mg vials and the company cannot estimate a release date.
  • Avenacy has bivalirudin 250 mg vials on allocation.
  • Par has bivalirudin 250 mg/50 mL ready-to-use vials on back order and the company estimates a release date of early-June 2026.

• • This drug is labeled for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).[1-2]
  • Bivalirudin may be used in patients with heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) or heparin-induced thrombocytopenia (HIT).[2]
  • Off-label uses include the use in cardiac surgery in patients with HIT when the surgery cannot be delayed.[2]

• • This medication may be used in patients with a history of HITTS or HIT.[1-2]

• • Argatroban is an alternative direct thrombin agent for use during PCI.[3] Argatroban may also be used as an alternative agent in patients with HIT.[4]

• 1. Bivalirudin injection [prescribing information]. E. Windsor, NJ: Eugia US LLC; December 2024.
  2. Bivalirudin. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed January 5, 2026.
  3. Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the management of patients with acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Accessed January 5, 2026. https://www.ahajournals.org/doi/epub/10.1161/CIR.0000000000001309
  4. Argatroban. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed February 11, 2026