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Restasis (cyclosporine 0.05%) — Competitive Intelligence Brief

Restasis (cyclosporine 0.05%) (Restasis (cyclosporine 0.05%)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: immunosuppressant. Area: Ophthalmology.

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)

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DrugGenericSponsorPhaseClassTargetApproval / 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)

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)

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

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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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