tacrolimus OD, mycophenolic acid, prednisolone — Competitive Intelligence Brief

tacrolimus OD, mycophenolic acid, prednisolone (tacrolimus OD, mycophenolic acid, prednisolone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Immunosuppressive combination therapy. Area: Immunology / Transplantation.

marketed Immunosuppressive combination therapy Calcineurin (tacrolimus); IMPDH (mycophenolic acid); glucocorticoid receptor (prednisolone) Immunology / Transplantation Small molecule

Target snapshot

tacrolimus OD, mycophenolic acid, prednisolone (tacrolimus OD, mycophenolic acid, prednisolone) — University Medical Center Groningen. This triple immunosuppressive regimen suppresses T-cell activation and proliferation to prevent organ rejection after transplantation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
tacrolimus OD, mycophenolic acid, prednisolone TARGET	tacrolimus OD, mycophenolic acid, prednisolone	University Medical Center Groningen	marketed	Immunosuppressive combination therapy	Calcineurin (tacrolimus); IMPDH (mycophenolic acid); glucocorticoid receptor (prednisolone)
Kidney transplant maintenance immunosuppression	Kidney transplant maintenance immunosuppression	Imperial College Healthcare NHS Trust	marketed	Immunosuppressive combination therapy
Cyclophosphamide, Azathioprine,prednisone,methylprednisolone	Cyclophosphamide, Azathioprine,prednisone,methylprednisolone	Assistance Publique - Hôpitaux de Paris	marketed	Immunosuppressive combination therapy
Dexamethasone Azathioprine Pulse therapy	Dexamethasone Azathioprine Pulse therapy	Jinnah Postgraduate Medical Centre	marketed	Immunosuppressive combination therapy	Glucocorticoid receptor (dexamethasone); inosine monophosphate dehydrogenase (azathioprine)
Sirolimus+MMF or MPS or AZA+Steroid	Sirolimus+MMF or MPS or AZA+Steroid	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	Immunosuppressive combination therapy	mTOR (sirolimus); IMPDH (MMF/MPS); purine synthesis (AZA); glucocorticoid receptor (steroid)
sirolimus, mycophenolat mofetil, fluvastatin	sirolimus, mycophenolat mofetil, fluvastatin	University Hospital Schleswig-Holstein	marketed	Immunosuppressive combination therapy with statin	mTOR, IMPDH, HMG-CoA reductase
Everolimus+Tacrolimus+Prednisone	Everolimus+Tacrolimus+Prednisone	Fundação Pró Rim	marketed	Immunosuppressive combination therapy	mTOR (everolimus), calcineurin (tacrolimus), glucocorticoid receptor (prednisone)

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 (Immunosuppressive combination therapy class)

1. University Hospital, Brest · 2 drugs in this class
2. Pfizer · 2 drugs in this class
3. Fundação Pró Rim · 2 drugs in this class
4. Haukeland University Hospital · 1 drug in this class
5. Imperial College Healthcare NHS Trust · 1 drug in this class
6. Jinnah Postgraduate Medical Centre · 1 drug in this class
7. Novartis · 1 drug in this class
8. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · 1 drug in this class
9. Swiss Cancer Institute · 1 drug in this class
10. University Hospital Freiburg · 1 drug in this class