cyclosporin + mycophenolate mofetil — Competitive Intelligence Brief

cyclosporin + mycophenolate mofetil (cyclosporin + mycophenolate mofetil) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: immunosuppressant. Area: Immunology.

phase 3 immunosuppressant calcineurin, inosine monophosphate dehydrogenase Immunology Small molecule

Target snapshot

cyclosporin + mycophenolate mofetil (cyclosporin + mycophenolate mofetil) — Centre Hospitalier Universitaire, Amiens. Cyclosporin is an immunosuppressant that inhibits calcineurin, while mycophenolate mofetil is an inhibitor of inosine monophosphate dehydrogenase, both of which are involved in the activation of T cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
cyclosporin + mycophenolate mofetil TARGET	cyclosporin + mycophenolate mofetil	Centre Hospitalier Universitaire, Amiens	phase 3	immunosuppressant	calcineurin, inosine monophosphate dehydrogenase
Mycophenolate	MYCOPHENOLIC ACID	Novartis	marketed	Antimetabolite Immunosuppressant	Inosine-5'-monophosphate dehydrogenase 2	2004-01-01
Elidel	PIMECROLIMUS	Bausch Health	marketed	Calcineurin Inhibitor Immunosuppressant [EPC]	Peptidyl-prolyl cis-trans isomerase FKBP1A	2001-01-01
Rapamune	sirolimus	Pfizer	marketed	mTOR Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein kinase mTOR	1999-01-01
SIROLIMUS	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01
Cellcept	MYCOPHENOLATE MOFETIL	Roche Palo	marketed	Antimetabolite Immunosuppressant	Inosine-5'-monophosphate dehydrogenase 2	1995-01-01
Prograf	TACROLIMUS	Astellas Pharma	marketed	Calcineurin Inhibitor Immunosuppressant	Interferon gamma	1994-01-01

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)

• 2028-05-30 — Prograf · 12403095 · Formulation · US
• 2028-05-30 — Prograf · 11419823 · Formulation · US
• 2028-05-30 — Prograf · 9549918 · Formulation · US
• 2028-05-30 — Prograf · 11123331 · Method of Use · US
• 2028-05-30 — Prograf · 11110081 · Method of Use · US
• 2028-05-30 — Prograf · 12083103 · Method of Use · US
• 2028-05-30 — Prograf · 10864199 · Method of Use · US
• 2028-05-30 — Prograf · 10166190 · Formulation · US
• 2028-08-30 — Prograf · 8685998 · Formulation · US
• 2028-08-30 — Prograf · 8664239 · Method of Use · US
• 2029-02-14 — Rapamune · 8911786 · Formulation · US
• 2030-04-15 — Rapamune · 10206887 · Formulation · US
• 2036-03-05 — Rapamune · 10705070 · Formulation · US
• 2036-03-05 — Rapamune · 12061183 · Formulation · US
• 2036-06-29 — Rapamune · 12133844 · Method of Use · US
• 2036-06-29 — Rapamune · 10973806 · Method of Use · US
• 2039-08-16 — Cellcept · 12097285 · Formulation · US
• 2039-08-16 — Cellcept · 11931455 · Formulation · US
• 2039-08-16 — Cellcept · 12226526 · Formulation · US
• 2039-08-16 — Cellcept · 12097284 · Formulation · US
• 2039-08-16 — Cellcept · 12194143 · Formulation · US
• 2040-10-28 — Rapamune · 11497737 · Formulation · US

Sponsor landscape (immunosuppressant class)

1. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
2. Centre Hospitalier Universitaire, Amiens · 1 drug in this class
3. DH Bio Co., Ltd. · 1 drug in this class
4. Glenmark Pharmaceuticals Ltd. India · 1 drug in this class
5. Palvella Therapeutics, Inc. · 1 drug in this class
6. Pfizer · 1 drug in this class
7. Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · 1 drug in this class
8. University of California, San Francisco · 1 drug in this class
9. Vanderbilt-Ingram Cancer Center · 1 drug in this class