Mycophenolic acid dose reduction — Competitive Intelligence Brief

Mycophenolic acid dose reduction (Mycophenolic acid dose reduction) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Immunosuppressant. Area: Immunology.

marketed Immunosuppressant Inosine monophosphate dehydrogenase (IMPDH) type II Immunology Small molecule

Target snapshot

Mycophenolic acid dose reduction (Mycophenolic acid dose reduction) — University of California, San Francisco. Mycophenolic acid dose reduction involves lowering the administered dose of mycophenolic acid, an immunosuppressant that inhibits inosine monophosphate dehydrogenase (IMPDH) to reduce T and B lymphocyte proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Mycophenolic acid dose reduction TARGET	Mycophenolic acid dose reduction	University of California, San Francisco	marketed	Immunosuppressant	Inosine monophosphate dehydrogenase (IMPDH) type II
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
SIROLIMUS	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01
Rapamune	sirolimus	Pfizer	marketed	mTOR Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein kinase 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 Hopitaux De Marseille · 1 drug in this class
2. Centre Hospitalier Universitaire, Amiens · 1 drug in this class
3. Hospices Civils de Lyon · 1 drug in this class
4. I.M. Sechenov First Moscow State Medical University · 1 drug in this class
5. Kenya Medical Research Institute · 1 drug in this class
6. Memorial Sloan Kettering Cancer Center · 1 drug in this class
7. National Heart, Lung, and Blood Institute (NHLBI) · 1 drug in this class
8. Peking Union Medical College Hospital · 1 drug in this class
9. RWTH Aachen University · 1 drug in this class
10. Samsung Medical Center · 1 drug in this class