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Restasis (cyclosporine 0.05%) — Competitive Intelligence Brief
phase 3
immunosuppressant
calcineurin
Ophthalmology
Small molecule
Live · refreshed every 30 min
Target snapshot
Restasis (cyclosporine 0.05%) (Restasis (cyclosporine 0.05%)) — DH Bio Co., Ltd.. Restasis works by increasing tear production in patients with dry eye syndrome.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Restasis (cyclosporine 0.05%) TARGET | Restasis (cyclosporine 0.05%) | DH Bio Co., Ltd. | phase 3 | immunosuppressant | 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 | |
| cyclosporine or tacrolimus | cyclosporine or tacrolimus | Russian Academy of Medical Sciences | marketed | Calcineurin inhibitor | Calcineurin (protein phosphatase 2B) | |
| tacrolimus ointment 0.1% | tacrolimus ointment 0.1% | Hospital de Clinicas de Porto Alegre | marketed | Calcineurin inhibitor | Calcineurin (via FKBP12 binding) | |
| rhTPO combined with Herombopag + CsA | rhTPO combined with Herombopag + CsA | Peking Union Medical College Hospital | marketed | Thrombopoietin receptor agonist combination with immunosuppressant | Thrombopoietin receptor (MPL); calcineurin (CsA target) | |
| Everolimus+Tacrolimus+Prednisone | Everolimus+Tacrolimus+Prednisone | Fundação Pró Rim | marketed | Immunosuppressive combination therapy | mTOR (everolimus), calcineurin (tacrolimus), glucocorticoid receptor (prednisone) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
- — Sandimmune · 8298568 · Formulation · US
- — Sandimmune · 9132071 · Formulation · US
- — Sandimmune · 8614178 · Formulation · US
- — Sandimmune · 8292129 · Formulation · US
- — Sandimmune · 8561859 · Formulation · US
- — Sandimmune · 8980839 · Formulation · US
- — Sandimmune · 10441630 · Formulation · US
- — Sandimmune · 9937225 · Formulation · US
- — Sandimmune · 9676525 · Formulation · US
- — Sandimmune · 9669974 · Formulation · US
- — Sandimmune · 12496326 · Method of Use · US
- — Sandimmune · 11951153 · Method of Use · US
- — Sandimmune · 10918694 · Formulation · US
- — Sandimmune · 10813976 · Formulation · US
- — Sandimmune · 11154513 · Formulation · US
- — Sandimmune · 11413323 · Method of Use · US
- — Sandimmune · 12059449 · Formulation · US
Sponsor landscape (immunosuppressant class)
- Assistance Publique - Hôpitaux de Paris · 1 drug in this class
- Centre Hospitalier Universitaire, Amiens · 1 drug in this class
- DH Bio Co., Ltd. · 1 drug in this class
- Glenmark Pharmaceuticals Ltd. India · 1 drug in this class
- Palvella Therapeutics, Inc. · 1 drug in this class
- Pfizer · 1 drug in this class
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · 1 drug in this class
- University of California, San Francisco · 1 drug in this class
- Vanderbilt-Ingram Cancer Center · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Restasis (cyclosporine 0.05%) — Competitive Intelligence Brief. https://druglandscape.com/ci/restasis-cyclosporine-0-05. Accessed 2026-05-18.
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