Cyclosporine Patent Expiration

Cyclosporine was first introduced by Novartis Pharmaceuticals Corp in its drug Sandimmune on Nov 14, 1983. Other drugs containing Cyclosporine are Restasis Multidose, Neoral, Cequa, Restasis, Vevye, Verkazia. 21 different companies have introduced drugs containing Cyclosporine.


Cyclosporine Patents

Given below is the list of patents protecting Cyclosporine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Vevye US12059449 Ophthalmic composition for treatment of dry eye disease Apr 01, 2042 Harrow Eye
Vevye US11413323 Ophthalmic composition for treatment of dry eye disease Oct 11, 2039 Harrow Eye
Vevye US11154513 Semifluorinated compounds Nov 20, 2038 Harrow Eye
Vevye US10813976 Ophthalmic compositions comprising ciclosporin Sep 22, 2037 Harrow Eye
Cequa US10918694 Topical cyclosporine-containing formulations and uses thereof Feb 28, 2037 Sun Pharm
Cequa US11951153 Topical cyclosporine-containing formulations and uses thereof Feb 28, 2037 Sun Pharm
Vevye US12496326 Ophthalmic Composition For Treatment Of Dry Eye Disease Sep 29, 2036 Harrow Eye
Restasis Multidose US9669974 Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids May 11, 2034 Abbvie
Restasis Multidose US9676525 Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Feb 07, 2034 Abbvie
Cequa US10441630 Topical formulations and uses thereof Aug 23, 2033 Sun Pharm
Cequa US8980839 Topical aqueous nanomicellar, ophthalmic solutions and uses thereof Aug 23, 2033 Sun Pharm
Cequa US9937225 Topical formulations and uses thereof Aug 23, 2033 Sun Pharm
Restasis Multidose US8561859 Dispensing device Apr 16, 2032 Abbvie
Restasis Multidose US8292129 Dispensing device Feb 25, 2031 Abbvie
Vevye US8614178 Pharmaceutical composition for treatment of dry eye syndrome Dec 13, 2030 Harrow Eye
Verkazia US9132071 Compositions containing quaternary ammonium compounds Jun 02, 2029 Harrow Eye
Verkazia US8298568 Oil-in-water type emulsion with low concentration of cationic agent and positive zeta potential Nov 03, 2027 Harrow Eye
Verkazia US11612658 Oil-in-water emulsions comprising cetalkonium chloride and methods of making and using the same Jan 27, 2026

(Expired)

Harrow Eye
Verkazia US7973081 Emulsion compositions containing quaternary ammonium compounds Jan 27, 2026

(Expired)

Harrow Eye
Verkazia US8524779 Emulsion compositions containing quaternary ammonium compounds Jan 27, 2026

(Expired)

Harrow Eye
Verkazia US9220694 Emulsion compositions containing cetalkonium chloride Jan 27, 2026

(Expired)

Harrow Eye
Verkazia US9956289 Emulsion compositions containing quaternary ammonium compounds Jan 27, 2026

(Expired)

Harrow Eye
Restasis US8629111 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis US8633162 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis US8642556 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis US8648048 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis US8685930 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis US9248191 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis Multidose US8629111 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis Multidose US8633162 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis Multidose US8642556 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis Multidose US8648048 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis Multidose US8685930 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Restasis Multidose US9248191 Methods of providing therapeutic effects using cyclosporin components Aug 27, 2024

(Expired)

Abbvie
Neoral US5985321 Soft gelatin capsule manufacture Sep 26, 2014

(Expired)

Novartis
Restasis US5474979 Nonirritating emulsions for sensitive tissue May 17, 2014

(Expired)

Abbvie



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Cyclosporine's patents.

Given below is the list recent legal activities going on the following patents of Cyclosporine.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 10 Feb, 2026 US11413323
Payment of Maintenance Fee, 8th Year, Large Entity 22 Oct, 2025 US9956289
Payment of Maintenance Fee, 12th Year, Large Entity 17 Jun, 2025 US8614178
Payment of Maintenance Fee, 4th Year, Large Entity 16 Apr, 2025 US11154513
Payment of Maintenance Fee, 12th Year, Large Entity 07 Apr, 2025 US8561859
Patent eCofC Notification 18 Feb, 2025 US11154513
Recordation of Patent eCertificate of Correction 18 Feb, 2025 US11154513
Mail Patent eCofC Notification 18 Feb, 2025 US11154513
Email Notification 18 Feb, 2025 US11154513
Post Issue Communication - Certificate of Correction 31 Jan, 2025 US11154513


About Veterinary Cyclosporine

Cyclosporine is used in drugs marketed by 5 different companies: Virbac Ah Inc, Ceva Sante Animale, Elanco Us Inc, Intervet Inc, Dechra Veterinary Products Llc.

Other drugs containing Cyclosporine are: Modulis for dogs , Atopica , Optimmune , Cyclavance

Cyclosporine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Cyclosporine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Cyclosporine has 1 clinical trial that has been verified in 2024.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation Emory University NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients University of Pennsylvania NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease Sanofi NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Sirolimus+Ruxolitinib+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to CNI Peking University People's Hospital NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Use of Bone Marrow Stem Cells (MesenCell) for the Treatment of Patients With Chronic Graft-versus-host Disease Pontifícia Universidade Católica do Paraná NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation. Central Hospital, Nancy, France NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Evaluation of the Efficacy of Zuberitamab Injection in Patients With Primary Membranous Nephropathy BioRay Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Reduced Intensity Conditioning (RIC) Regimen for Patients With Non-malignant Disorders Children's Hospital of Philadelphia NA COMPLETED
(Aug 1, 2026)
PHASE2
Topical Ruxolitinib in the Treatment of Adults With Pyoderma Gangrenosum Oregon Health and Science University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Study of a Copaiba-Based Mouthwash Combined With Low-Level Laser Therapy in the Prevention of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation Instituto Nacional de Cancer, Brazil NA RECRUITING
(Aug 1, 2026)
PHASE2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) NA RECRUITING
(Jul 17, 2026)
PHASE2
Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR University Hospital, Angers NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia Novartis Pharmaceuticals NA COMPLETED
(Jul 1, 2026)
PHASE2
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Assistance Publique - Hôpitaux de Paris NA RECRUITING
(Jul 1, 2026)
PHASE2
Study of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease. Tata Memorial Centre NA RECRUITING
(Jul 1, 2026)
PHASE2
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE2
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia Fred Hutchinson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A University of California, San Francisco NA RECRUITING
(Jun 1, 2026)
PHASE3
Enarodustat+CsA vs CsA in the Treatment of Newly-diagnosed TD-NSAA Peking Union Medical College Hospital NA WITHDRAWN
(Jun 1, 2026)
PHASE3
CsA+EPAG/HPAG+Romiplostim N01 in the Treatment of Newly-diagnosed SAA/TD-NSAA Peking Union Medical College Hospital NA WITHDRAWN
(Jun 1, 2026)
PHASE2
rhTPO + CsA vs CsA in the Treatment of LR-MDS With Thrombocytopenia Peking Union Medical College Hospital NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis Boston Children's Hospital NA RECRUITING
(May 1, 2026)
PHASE2
Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia Fred Hutchinson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia National Heart, Lung, and Blood Institute (NHLBI) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants Eli Lilly and Company NA COMPLETED
(Apr 1, 2026)
PHASE1
Cyclosporine In Takotsubo Syndrome University Hospital Heidelberg NA RECRUITING
(Apr 1, 2026)
PHASE2
Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA Peking Union Medical College Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA Peking Union Medical College Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Treatment of Familiar Lymphohistiocytosis Assistance Publique - Hôpitaux de Paris NA COMPLETED
(Mar 1, 2026)
PHASE1, PHASE2
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Oct, 2024)
PHASE2
The Effect of Cyclosporin Before Cataract Surgery Samsung Medical Center NA COMPLETED
(May, 2022)
PHASE4
Efficacy and Safety of Lenalidomide in Combination With Cyclosporine A in Patients With Myelodysplastic Syndromes Weill Medical College of Cornell University Celgene TERMINATED
(Nov, 2019)
PHASE2
Investigation of Flare and Remission in Subjects With Atopic Dermatitis LEO Pharma NA WITHDRAWN
(Jul, 2019)
PHASE4
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum London School of Hygiene and Tropical Medicine Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia COMPLETED
(Mar, 2015)
PHASE2
Restasis for Treatment of Brittle Nails Julian M. Mackay-Wiggan Allergan COMPLETED
(Jul, 2013)
PHASE2
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients APT Pharmaceuticals, Inc. NA NO LONGER AVAILABLE
(Sep, 2012)
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection Novartis Pharmaceuticals NA COMPLETED
(Jul, 2012)
PHASE3
Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation Assistance Publique - Hôpitaux de Paris Agence de La Biomédecine COMPLETED
(Jul, 2009)
PHASE2
Low Dose Cyclosporin and Methotrexate Therapy in Diabetes Georgetown University NA COMPLETED
(May, 2009)
NA


Cyclosporine Generic API Manufacturers

Several generic applications have been filed for Cyclosporine. The first generic version for Cyclosporine was by Hikma Pharmaceuticals Usa Inc and was approved on Oct 29, 1999. And the latest generic version is by Jiangsu Anbison Pharmaceutical Co Ltd and was approved on Jun 1, 2026.

Given below is the list of companies who have filed for Cyclosporine generic, along with the locations of their manufacturing plants worldwide.