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Last Updated: March 28, 2024

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 nine branded drugs marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Abbvie, Novartis, Mylan, Teva Pharms Usa Inc, Harrow Eye, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-six NDAs. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has two hundred and ninety-three patent family members in thirty-three countries.

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

Drug Prices for cyclosporine

See drug prices for cyclosporine

Recent Clinical Trials for cyclosporine

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

SponsorPhase
Beijing Mabworks Biotech Co., Ltd.Phase 3
Aarhus University Hospital, Department of NephrologyPhase 4
Odense University Hospital, Department of NephrologyPhase 4

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
Abbvie RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan CYCLOSPORINE cyclosporine EMULSION;OPHTHALMIC 205894-001 Feb 2, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm CEQUA cyclosporine SOLUTION;OPHTHALMIC 210913-001 Aug 14, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 050715-003 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for cyclosporine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1809237 122015000043 Germany ⤷  Try a Trial PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319
2049079 PA2017003,C2049079 Lithuania ⤷  Try a Trial PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
2049079 LUC00006 Luxembourg ⤷  Try a Trial PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.