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Cyclosporine Patent Expiration

Cyclosporine was first introduced by Novartis Pharmaceuticals Corp in its drug Sandimmune on Nov 14, 1983. Other drugs containing Cyclosporine are Cequa, Restasis Multidose, Restasis, Neoral, Verkazia, Vevye. 17 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.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
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
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 Harrow Eye
Verkazia US7973081 Emulsion compositions containing quaternary ammonium compounds Jan 27, 2026 Harrow Eye
Verkazia US8524779 Emulsion compositions containing quaternary ammonium compounds Jan 27, 2026 Harrow Eye
Verkazia US9220694 Emulsion compositions containing cetalkonium chloride Jan 27, 2026 Harrow Eye
Verkazia US9956289 Emulsion compositions containing quaternary ammonium compounds Jan 27, 2026 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, 12th Year, Large Entity 23 Apr, 2024 US8298568
Payment of Maintenance Fee, 4th Year, Large Entity 19 Apr, 2024 US10813976
Payment of Maintenance Fee, 12th Year, Large Entity 09 Apr, 2024 US8292129
Payment of Maintenance Fee, 8th Year, Large Entity 21 Jun, 2023 US9220694
Electronic Review
Critical
 24 May, 2023 US11413323
Post Issue Communication - Certificate of Correction 05 May, 2023 US11413323
Recordation of Patent Grant Mailed
Critical
 28 Mar, 2023 US11612658
Patent Issue Date Used in PTA Calculation
Critical
 28 Mar, 2023 US11612658
Email Notification
Critical
 09 Mar, 2023 US11612658
Payment of Maintenance Fee, 8th Year, Large Entity 09 Mar, 2023 US9132071


Cyclosporine's 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
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia Novartis Pharmaceuticals ACTIVE NOT RECRUITING
(Oct, 2024)
 PHASE2
The Effect of Cyclosporin Before Cataract Surgery Samsung Medical Center 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 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. NO LONGER AVAILABLE
(Sep, 2012)
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection Novartis Pharmaceuticals 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 COMPLETED
(May, 2009)
 NA




Cyclosporine Generics

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 Saptalis Pharmaceuticals Llc and was approved on Jul 5, 2024.

Given below is the list of companies who have filed for Cyclosporine generic.


1. ABBVIE

Abbvie Inc has filed for 4 different strengths of generic version for Cyclosporine. Out of these 100mg version comes by the name GENGRAF, 50mg version comes by the name GENGRAF, 25mg version comes by the name GENGRAF. Given below are the details of the strengths of this generic introduced by Abbvie.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML solution Prescription ORAL AB1 Mar 3, 2000
100MG capsule Prescription ORAL AB1 May 12, 2000
50MG capsule Discontinued ORAL N/A May 12, 2000
25MG capsule Prescription ORAL AB1 May 12, 2000


2. APOTEX

Apotex Inc has filed for 4 different strengths of generic version for Cyclosporine. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB1 Jul 10, 2019
100MG capsule Prescription ORAL AB1 Jul 10, 2019
50MG capsule Prescription ORAL AB1 Jul 10, 2019
0.05% emulsion Prescription OPHTHALMIC AB Jan 12, 2023


3. DEVA HOLDING AS

Deva Holding As has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Deva Holding As.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05% emulsion Prescription OPHTHALMIC AB May 21, 2024


4. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Cyclosporine. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB1 Dec 20, 2000
100MG capsule Prescription ORAL AB1 Dec 20, 2000
100MG/ML solution Discontinued ORAL N/A Dec 18, 2001


5. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML injectable Prescription INJECTION AP Oct 29, 1999


6. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Cyclosporine. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML solution Prescription ORAL AB1 Mar 25, 2005
100MG capsule Prescription ORAL AB1 Mar 29, 2005
50MG capsule Prescription ORAL AB1 Mar 29, 2005
25MG capsule Prescription ORAL AB1 Mar 29, 2005


7. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05% emulsion Prescription OPHTHALMIC AB Feb 2, 2022


8. PADAGIS US

Padagis Us Llc has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML injectable Prescription INJECTION AP Oct 7, 2003


9. PHARM ASSOC

Pharmaceutical Associates Inc has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Pharm Assoc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML solution Discontinued ORAL N/A Jan 5, 2005


10. PHARMOBEDIENT CNSLTG

Pharmobedient Consulting has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Pharmobedient Cnsltg.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/ML solution Discontinued ORAL N/A Sep 17, 2004


11. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Cyclosporine. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB1 Jan 13, 2000
100MG capsule Prescription ORAL AB1 Jan 13, 2000


12. SAPTALIS PHARMS

Saptalis Pharmaceuticals Llc has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Saptalis Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05% emulsion Prescription OPHTHALMIC AB Jul 5, 2024


13. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Cyclosporine. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB1 Aug 2, 2022
100MG capsule Prescription ORAL AB1 Aug 2, 2022
50MG capsule Prescription ORAL AB1 Aug 2, 2022


14. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Cyclosporine. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05% emulsion Discontinued OPHTHALMIC N/A Dec 14, 2023