Dalteparin (Fragmin) — Competitive Intelligence Brief

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

marketed Low-molecular-weight heparin (LMWH) Antithrombin III (indirect target); Factor Xa and Factor IIa (thrombin) Cardiovascular Small molecule

Target snapshot

Dalteparin (Fragmin) (Dalteparin (Fragmin)) — M.D. Anderson Cancer Center. Dalteparin is a low-molecular-weight heparin that inhibits blood coagulation by enhancing the activity of antithrombin III against factor Xa and thrombin.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Dalteparin (Fragmin) TARGET	Dalteparin (Fragmin)	M.D. Anderson Cancer Center	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (indirect target); Factor Xa and Factor IIa (thrombin)
Hepalean Heparin	Hepalean Heparin	McMaster University	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (indirect target); Factors Xa and IIa
enoxaparin/tinzaparin/dalteparin	enoxaparin/tinzaparin/dalteparin	Helsinki University Central Hospital	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (indirect); Factor Xa and Factor IIa
Innohep (tinzaparin)	Innohep (tinzaparin)	Ottawa Hospital Research Institute	marketed	Low-molecular-weight heparin (LMWH)	Factor Xa and thrombin (via antithrombin III enhancement)
Enoxaparin (High-dose Group)	Enoxaparin (High-dose Group)	Peking Union Medical College Hospital	marketed	Low-molecular-weight heparin (LMWH)	Antithrombin III (enhancer); Coagulation factors Xa and IIa (indirect targets)
Usual dose adjustment of enoxaparin	Usual dose adjustment of enoxaparin	Assistance Publique - Hôpitaux de Paris	marketed	Low-molecular-weight heparin (LMWH)	Factor Xa and Factor IIa (via antithrombin III)
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)

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