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Last Updated: March 29, 2024

Cyclosporine - Generic Drug Details


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What are the generic sources for cyclosporine and what is the scope of freedom to operate?

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
Odense University Hospital, Department of NephrologyPhase 4
Aarhus 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
Strides Pharma CYCLOSPORINE cyclosporine CAPSULE;ORAL 216046-002 Aug 2, 2022 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc CYCLOSPORINE cyclosporine EMULSION;OPHTHALMIC 203880-001 Dec 14, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz CYCLOSPORINE cyclosporine CAPSULE;ORAL 065017-002 Jan 13, 2000 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDIMMUNE cyclosporine INJECTABLE;INJECTION 050573-001 Nov 14, 1983 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye VERKAZIA cyclosporine EMULSION;OPHTHALMIC 214965-001 Jun 23, 2021 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
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-001 Mar 2, 1990 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for cyclosporine

Country Patent Number Title Estimated Expiration
Spain 2317319 ⤷  Try a Trial
Croatia P20230559 ⤷  Try a Trial
Mexico 2019003364 COMPOSICIONES OFTALMICAS QUE COMPRENDEN CICLOSPORINA. (OPHTHALMIC COMPOSITIONS COMPRISING CICLOSPORIN.) ⤷  Try a Trial
Poland 2887923 ⤷  Try a Trial
Austria E479424 ⤷  Try a Trial
Hong Kong 1107938 OPHTHALMIC OIL-IN-WATER TYPE EMULSION WITH STABLE POSITIVE ZETA POTENTIAL ⤷  Try a Trial
Poland 1891939 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cyclosporine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1809237 C01809237/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016
2049079 PA2017003 Lithuania ⤷  Try a Trial PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237 CR 2015 00030 Denmark ⤷  Try a Trial PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323
1809237 122015000043 Germany ⤷  Try a Trial PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237 C300741 Netherlands ⤷  Try a Trial PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
2049079 LUC00006 Luxembourg ⤷  Try a Trial PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
1809237 CA 2015 00030 Denmark ⤷  Try a Trial PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 20150319
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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