CsA low dose — Competitive Intelligence Brief

CsA low dose (CsA low dose) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: calcineurin inhibitor. Area: Immunology.

phase 2 calcineurin inhibitor calcineurin Immunology Small molecule

Target snapshot

CsA low dose (CsA low dose) — Fovea Pharmaceuticals SA. CsA works by inhibiting calcineurin, a protein phosphatase involved in the activation of T-lymphocytes.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
CsA low dose TARGET	CsA low dose	Fovea Pharmaceuticals SA	phase 2	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
TacroBell SR cap.	TacroBell SR cap.	Chong Kun Dang Pharmaceutical	marketed	Calcineurin inhibitor	Calcineurin (via FKBP12 binding)
Cyclosporine 0.05%	Cyclosporine 0.05%	Ophthalmic Consultants of Long Island	marketed	Calcineurin inhibitor	Calcineurin
Tacrolimus Ointment 0.03%	Tacrolimus Ointment 0.03%	Astellas Pharma Inc	marketed	Calcineurin inhibitor	Calcineurin (via FKBP12 binding)
Neoral	Neoral	Novartis Pharmaceuticals	marketed		Calcineurin subunit B type 1, Canalicular multispecific organic anion transporter 1, Canalicular multispecific organic anion transporter 2

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. Sanofi · 2 drugs in this class
2. Fovea Pharmaceuticals SA · 1 drug in this class
3. Galderma R&D · 1 drug in this class
4. Glenmark Pharmaceuticals Ltd. India · 1 drug in this class