Cyclosporine Patent Expiration
Cyclosporine was first introduced by Novartis Pharmaceuticals Corp
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 | 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 |
| 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.
Latest 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 |
|---|---|---|
 | ||
| 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
Explore Our Curated Drug Screens
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.
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 Saptalis Pharmaceuticals Llc and was approved on Jul 5, 2024.
Given below is the list of companies who have filed for Cyclosporine generic, along with the locations of their manufacturing plants worldwide.
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 | Discontinued | ORAL | N/A | 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 |
Manufacturing Plant Locations New
Abbvie's manufacturing plants are situated in 5 countries - United States, Germany, Ireland, Singapore, Italy. Given below are the details of these plant locations as well as the firm names of Abbvie as present at those locations.
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| United States |
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| Germany |
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| Ireland |
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| Singapore |
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| Italy |
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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 | Discontinued | OPHTHALMIC | N/A | Jan 12, 2023 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
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| United States |
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| Canada |
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| India |
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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 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Portugal |
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| Jordan |
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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 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
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| Ireland |
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8. ONESOURCE SPECIALTY
Onesource Specialty 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 Onesource Specialty.
| 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 |
9. 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 |
Manufacturing Plant Locations New
Padagis Us's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Padagis Us as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
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10. 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 |
11. 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 |
12. 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 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
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| Austria |
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| United States |
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| Spain |
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| India |
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13. 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 |
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 | Prescription | OPHTHALMIC | AB | Dec 14, 2023 |