Bivalirudin

Bivalirudin is a specific and reversible direct thrombin inhibitor. It is a parenteral bivalent analog of Hirudin. Direct thrombin inhibitors such as bivalirudin block circulating thrombin and clot-bound thrombin.
Bivalirudin is used as an anticoagulant in patients undergoing percutaneous coronary interventions, including those with, or at risk of, heparin-induced thrombocytopenia. It has also been investigated in patients with acute coronary syndromes treated medically
In addition, Bivalirudin is FDA-approved for treatment of unstable angina (i.e., myocardial infarction prophylaxis) in patients undergoing PTCA.

Bivalirudin’s innovator is Medicines Company and is known globally by the brand name Angiomax.

Bivalirudin is a selective direct thrombin inhibitor similar to lepirudin, a recombinant form of the natural anticoagulant hirudin. Bivalirudin reversibly inhibits the catalytic site of thrombin, neutralizing the actions of thrombin, including thrombin entrapped within established clots. It ultimately interferes with fibrin generation, platelet aggregation, factor XII activation, and other related biologic activities. Thrombin is a serine protease that plays a central role in the thrombotic process, acting to split fibrinogen into fibrin monomers and to trigger Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus.
Because all thrombin-dependent coagulation assays are affected, thrombin times are not helpful in monitoring bivalirudin activity. Similar to argatroban, bivalirudin binds reversibly to thrombin resulting in shorter duration of clinical activity upon discontinuation of the drug.

The FDA approved bivalirudin for the treatment of patients with unstable angina undergoing PTCA on December 15, 2000.

General data on Bivalirudin Active Pharmaceutical Ingredients

CAS Registry: 128270-60-0
ATC: B01AE06
Molecular Formula: C98H138N24O33
Molecular Weight: 2180.3

TAPI's Bivalirudin Active Pharmaceutical Ingredient

TAPI's Bivalirudin Acetate Active Pharmaceutical Ingredient is produced in Assia Industries Limited –Teva Tech site in Beer Sheva, Israel.

Over the last 15 years TAPI has developed the expertise in developing and commercialization of peptide Active pharmaceutical ingredients, such as Bivalirudin. With numerous worldwide approvals, we are continuously driven by the goal of helping our customers achieve success-and ultimately approval for their peptide APIs. We offer grams to hundred kilograms production capabilities, comprehensive technology platform including solid phase, solution phase, and hybrid approach, combined with a well established scientific experience, enabling the implementation of efficient process aimed for high quality product. We offer Custom Synthesis and Manufacturing services on peptide Active pharmaceutical ingredients.

Other peptides available on TAPI's portfolio are:, Desmopressin Acetate, Eptifibatide, Exenatide, Tariparatide Acetate, Leuprolide/ Leuprorelin Acetate and Octreotide Acetate. Contact us today for sample availability and any other information on these products.

TAPI provide full service on Bivalirudin and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Bivalirudin. Contact us today for further inquiries and samples availability information for TAPI's Bivalirudin.

TAPI's Bivalirudin has unique features that might be an advantage for final dosage development. TAPI has filed several patent applications for Bivalirudin. Please, see table below for issued patents and pending applications.

Legal Note

Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products  that  Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).

*TAPI stands for Teva's Active Pharmaceutical Ingredients