Sodium Enoxaparin clexane — Competitive Intelligence Brief

Sodium Enoxaparin clexane (Sodium Enoxaparin clexane) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Low-molecular-weight heparin (LMWH). Area: Cardiovascular.

phase 3 Low-molecular-weight heparin (LMWH) Coagulation factors Xa and IIa (via antithrombin III) Cardiovascular Small molecule

Target snapshot

Sodium Enoxaparin clexane (Sodium Enoxaparin clexane) — Cristália Produtos Químicos Farmacêuticos Ltda.. Enoxaparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factors Xa and IIa.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sodium Enoxaparin clexane TARGET	Sodium Enoxaparin clexane	Cristália Produtos Químicos Farmacêuticos Ltda.	phase 3	Low-molecular-weight heparin (LMWH)	Coagulation factors Xa and IIa (via antithrombin III)
Fixed low dose tinzaparin	Fixed low dose tinzaparin	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (indirect target); Coagulation factors Xa and IIa
Hepalean Heparin	Hepalean Heparin	McMaster University	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (indirect target); Factors Xa and IIa
Intermediate dose nadroparin	Intermediate dose nadroparin	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	marketed	Low-molecular-weight heparin (LMWH)	Factor Xa, Thrombin (via antithrombin III enhancement)
Sodium Enoxaparine	Sodium Enoxaparine	Biocad	marketed	Low-molecular-weight heparin (LMWH)	Factor Xa and Factor IIa (via antithrombin III enhancement)
Tinzaparin continuous infusion	Tinzaparin continuous infusion	Tampere University Hospital	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (enhancer); Factor Xa and Factor IIa (indirect targets)
dalteparin injection	dalteparin injection	University of Rochester	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (Factor Xa and Factor IIa)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Low-molecular-weight heparin (LMWH) class)

1. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · 7 drugs in this class
2. University of Melbourne · 3 drugs in this class
3. French Cardiology Society · 2 drugs in this class
4. Ottawa Hospital Research Institute · 2 drugs in this class
5. McMaster University · 2 drugs in this class
6. Assistance Publique - Hôpitaux de Paris · 2 drugs in this class
7. GlaxoSmithKline · 1 drug in this class
8. IRCCS Azienda Ospedaliero-Universitaria di Bologna · 1 drug in this class
9. Cristália Produtos Químicos Farmacêuticos Ltda. · 1 drug in this class
10. Helsinki University Central Hospital · 1 drug in this class