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Last Updated: August 14, 2020

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CYCLOSPORINE - Generic Drug Details

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What are the generic sources for cyclosporine and what is the scope of patent protection?

Cyclosporine is the generic ingredient in seven branded drugs marketed by Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Sandoz, Abbvie, Novartis, Allergan, Am Regent, West-ward Pharms Int, Sun Pharma Global, Pharm Assoc, and Wockhardt Bio Ag, and is included in twenty NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has sixty-five patent family members in twenty-five countries.

There are eighteen drug master file entries for cyclosporine. Ten suppliers are listed for this compound.

Drug Prices for CYCLOSPORINE

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Recent Clinical Trials for CYCLOSPORINE

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SponsorPhase
Central Hospital, Nancy, FrancePhase 3
Ministry of Health, KuwaitN/A
Ameera Gamal AbdelhameedN/A

See all CYCLOSPORINE clinical trials

US Patents and Regulatory Information for CYCLOSPORINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CYCLOSPORINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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