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Last Updated: April 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-four patent family members in thirty-three countries.

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

Summary for cyclosporine

International Patents:	294
US Patents:	25
Tradenames:	9
Applicants:	15
NDAs:	26
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1,050
Patent Applications:	7,661
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for cyclosporine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cyclosporine
What excipients (inactive ingredients) are in cyclosporine?	cyclosporine excipients list
DailyMed Link:	cyclosporine at DailyMed

See drug prices for cyclosporine

Recent Clinical Trials for cyclosporine

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

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

See all cyclosporine clinical trials

Pharmacology for cyclosporine

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for cyclosporine

Antifungal Agents
Antirheumatic Agents
Calcineurin Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents

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

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Glossary

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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	210721-002	Jul 10, 2019	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	210721-003	Jul 10, 2019	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
Strides Pharma	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	216046-003	Aug 2, 2022	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	CYCLOSPORINE	cyclosporine	INJECTABLE;INJECTION	065004-001	Oct 29, 1999	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	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	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	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	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

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Country	Patent Number	Title	Estimated Expiration
Norway	3132004		⤷ Try a Trial
Canada	2914472	FORMULATION OPHTALMIQUE D'ACIDE GRAS OU LIPIDIQUE DE POLYOXYLE, ET TRAITEMENT DE PATHOLOGIES OCULAIRES (OPHTHALMIC FORMULATION OF POLYOXYL LIPID OR POLYOXYL FATTY ACID AND TREATMENT OF OCULAR CONDITIONS)	⤷ Try a Trial
Canada	3050298	FORMULATION OPHTALMIQUE D'ACIDE GRAS OU LIPIDIQUE DE POLYOXYLE ET D'ALCOOL DE POLYOXYETHYLENE, ET TRAITEMENT DE PATHOLOGIES OCULAIRES (OPHTHALMIC FORMULATION OF POLYOXYL LIPID OR POLYOXYL FATTY ACID AND POLYALKOXYLATED ALCOHOL FOR USE IN THE TREATMENT OF OCULAR CONDITIONS)	⤷ Try a Trial
Mexico	2018010395	FORMULACIONES TOPICAS QUE CONTIENEN CLICLOSPORINA Y USOS DE LAS MISMAS. (TOPICAL CYCLOSPORINE-CONTAINING FORMULATIONS AND USES THEREOF.)	⤷ Try a Trial
Japan	2017508673	ディスペンサーのための保護キャップ、及び医薬液体及び／又は化粧品液体を放出するための放出装置	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cyclosporine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	PA2017003,C2049079	Lithuania	⤷ Try a Trial	PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237	CA 2015 00030	Denmark	⤷ Try a Trial	PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 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	CR 2015 00030	Denmark	⤷ Try a Trial	PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323
1809237	C01809237/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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