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Last Updated: November 21, 2024

CYCLOSPORINE Drug Patent Profile


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Which patents cover Cyclosporine, and what generic alternatives are available?

Cyclosporine is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg. and is included in eighteen NDAs.

The generic ingredient in CYCLOSPORINE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cyclosporine

A generic version of CYCLOSPORINE was approved as cyclosporine by HIKMA on October 29th, 1999.

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Drug patent expirations by year for CYCLOSPORINE
Drug Prices for CYCLOSPORINE

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Recent Clinical Trials for CYCLOSPORINE

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

SponsorPhase
National Cord Blood NetworkPhase 2
Fred Hutchinson Cancer CenterPhase 2
Assiut UniversityPhase 1

See all CYCLOSPORINE clinical trials

Paragraph IV (Patent) Challenges for CYCLOSPORINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RESTASIS MULTIDOSE Ophthalmic Emulsion cyclosporine 0.05% 050790 1 2014-01-13

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
Apotex CYCLOSPORINE cyclosporine CAPSULE;ORAL 065040-001 May 9, 2002 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan CYCLOSPORINE cyclosporine EMULSION;OPHTHALMIC 205894-001 Feb 2, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa CYCLOSPORINE cyclosporine SOLUTION;ORAL 065054-001 Dec 18, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa CYCLOSPORINE cyclosporine CAPSULE;ORAL 065044-001 Dec 20, 2000 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex CYCLOSPORINE cyclosporine CAPSULE;ORAL 065040-002 May 9, 2002 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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