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Last Updated: March 4, 2021

DrugPatentWatch Database Preview

Cyclosporine - Generic Drug Details

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What are the generic drug 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, Paddock Labs Llc, 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boston SightPhase 3
Shanghai Fosun Pharmaceutical Development Co, Ltd.Phase 3
SobiPhase 3

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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
Ivax Sub Teva Pharms CYCLOSPORINE cyclosporine CAPSULE;ORAL 065110-003 Mar 29, 2005 AB1 RX No No   Start Trial   Start Trial   Start Trial
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
Sandoz CYCLOSPORINE cyclosporine CAPSULE;ORAL 065017-001 Jan 13, 2000 AB1 RX No No   Start Trial   Start Trial   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 CAPSULE;ORAL 050715-002 Jul 14, 1995   Start Trial   Start Trial
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Dow
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McKinsey
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Baxter

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