tacrolimus + mycophenolate mofetil — Competitive Intelligence Brief

tacrolimus + mycophenolate mofetil (tacrolimus + mycophenolate mofetil) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Immunosuppressant combination. Area: Immunology / Transplantation.

phase 3 Immunosuppressant combination Calcineurin (tacrolimus); Inosine monophosphate dehydrogenase (mycophenolate mofetil) Immunology / Transplantation Small molecule

Target snapshot

tacrolimus + mycophenolate mofetil (tacrolimus + mycophenolate mofetil) — Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. This combination suppresses T-cell activation and proliferation through calcineurin inhibition (tacrolimus) and inosine monophosphate dehydrogenase inhibition (mycophenolate mofetil) to prevent organ rejection.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
tacrolimus + mycophenolate mofetil TARGET	tacrolimus + mycophenolate mofetil	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	phase 3	Immunosuppressant combination	Calcineurin (tacrolimus); Inosine monophosphate dehydrogenase (mycophenolate mofetil)
Mycophenolate to sirolimus switch	Mycophenolate to sirolimus switch	London Health Sciences Centre	marketed	Immunosuppressant combination therapy	mTOR (sirolimus component); IMPDH (mycophenolate component being replaced)
infliximab+azathioprine	infliximab+azathioprine	Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW	marketed	TNF-α inhibitor + immunosuppressant combination	TNF-α receptor (infliximab); purine metabolism (azathioprine)
Tacrolimus/MMF	Tacrolimus/MMF	University of Miami	marketed	Immunosuppressant combination	Calcineurin (tacrolimus); IMPDH type II (MMF)
XR-tacrolimus QD + MMF BID then MMF QD	XR-tacrolimus QD + MMF BID then MMF QD	University Hospital, Limoges	marketed	Calcineurin inhibitor + Antimetabolite immunosuppressant combination	Calcineurin (tacrolimus); Inosine monophosphate dehydrogenase (mycophenolate mofetil)
XR-tacrolimus QD + MMF BID	XR-tacrolimus QD + MMF BID	University Hospital, Limoges	marketed	Calcineurin inhibitor + Antimetabolite immunosuppressant combination	Calcineurin (tacrolimus); IMPDH type II (mycophenolate mofetil)
MMF (Cellcept) and Steroids	MMF (Cellcept) and Steroids	University of Luebeck	marketed	Immunosuppressant combination (inosine monophosphate dehydrogenase inhibitor + corticosteroid)	IMPDH type II; glucocorticoid receptor

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 (Immunosuppressant combination class)

1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · 1 drug in this class
2. St. Anne's University Hospital Brno, Czech Republic · 1 drug in this class
3. Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · 1 drug in this class
4. University of Giessen · 1 drug in this class
5. University of Miami · 1 drug in this class