cyclosporine micro-emulsion — Competitive Intelligence Brief

cyclosporine micro-emulsion (cyclosporine micro-emulsion) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Calcineurin inhibitor. Area: Immunology.

marketed Calcineurin inhibitor Calcineurin Immunology Small molecule

Target snapshot

cyclosporine micro-emulsion (cyclosporine micro-emulsion) — Novartis. Cyclosporine micro-emulsion is an immunosuppressant that inhibits calcineurin, blocking T-cell activation and proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
cyclosporine micro-emulsion TARGET	cyclosporine micro-emulsion	Novartis	marketed	Calcineurin inhibitor	Calcineurin
Sandimmune	cyclosporine	Novartis AG (originally Sandoz)	marketed	Calcineurin inhibitor (immunosuppressant)	Calcineurin subunit B type 1, Canalicular multispecific organic anion transporter 1, Canalicular multispecific organic anion transporter 2	1983-11-14
CYCLOSPORINE	CYCLOSPORINE		marketed	Calcineurin Inhibitor Immunosuppressant [EPC]	calcineurin	1983-01-01
sirolimus, tacrolimus, mycophenolate mofetil	sirolimus, tacrolimus, mycophenolate mofetil	National Taiwan University Hospital	marketed	Immunosuppressive agent combination	mTOR, calcineurin, IMPDH
ATG+mycophénolate mofétil+tacrolimus	ATG+mycophénolate mofétil+tacrolimus	University Hospital, Toulouse	marketed	Immunosuppressive combination therapy	T lymphocytes (ATG); IMPDH (mycophenolate mofetil); calcineurin (tacrolimus)
Rectal tacrolimus	Rectal tacrolimus	The University of Western Australia	marketed	Calcineurin inhibitor	Calcineurin (protein phosphatase 2B)
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)

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)

• 2027-11-03 — Sandimmune · 8298568 · Formulation · US
• 2029-06-02 — Sandimmune · 9132071 · Formulation · US
• 2030-12-13 — Sandimmune · 8614178 · Formulation · US
• 2031-02-25 — Sandimmune · 8292129 · Formulation · US
• 2032-04-16 — Sandimmune · 8561859 · Formulation · US
• 2033-08-23 — Sandimmune · 8980839 · Formulation · US
• 2033-08-23 — Sandimmune · 10441630 · Formulation · US
• 2033-08-23 — Sandimmune · 9937225 · Formulation · US
• 2034-02-07 — Sandimmune · 9676525 · Formulation · US
• 2034-05-11 — Sandimmune · 9669974 · Formulation · US
• 2036-09-29 — Sandimmune · 12496326 · Method of Use · US
• 2037-02-28 — Sandimmune · 11951153 · Method of Use · US
• 2037-02-28 — Sandimmune · 10918694 · Formulation · US
• 2037-09-22 — Sandimmune · 10813976 · Formulation · US
• 2038-11-20 — Sandimmune · 11154513 · Formulation · US
• 2039-10-11 — Sandimmune · 11413323 · Method of Use · US
• 2042-04-01 — Sandimmune · 12059449 · Formulation · US

Sponsor landscape (Calcineurin inhibitor class)

1. Novartis · 4 drugs in this class
2. Astellas Pharma Inc · 4 drugs in this class
3. Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · 4 drugs in this class
4. University of Cincinnati · 3 drugs in this class
5. Allergan · 3 drugs in this class
6. Astellas Pharma China, Inc. · 3 drugs in this class
7. Novaliq GmbH · 3 drugs in this class
8. Hoffmann-La Roche · 3 drugs in this class
9. LEO Pharma · 3 drugs in this class
10. Santen SAS · 3 drugs in this class