Cyclosporine - Generic Drug Details

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, Harrow Eye, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-five 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 eighty-seven patent family members in thirty-three countries.

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

Summary for cyclosporine

International Patents:	287
US Patents:	25
Tradenames:	9
Applicants:	14
NDAs:	25
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1,050
Patent Applications:	6,026
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
Odense University Hospital, Department of Nephrology	Phase 4
Aarhus 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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	CYCLOSPORINE	cyclosporine	SOLUTION;ORAL	065025-001	Mar 3, 2000	AB1	RX	No	No
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes			Y
Apotex	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	210721-003	Jul 10, 2019	AB1	RX	No	No
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes			Y
Abbvie	GENGRAF	cyclosporine	CAPSULE;ORAL	065003-002	May 12, 2000		DISCN	No	No
Strides Pharma	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	216046-003	Aug 2, 2022	AB1	RX	No	No

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
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995

International Patents for cyclosporine

Country	Patent Number	Title	Estimated Expiration
Germany	102009006431	Austragvorrichtung
European Patent Office	2210674	Dispositif de sortie (Application device)
Russian Federation	2672959	ЗАЩИТНЫЙ КОЛПАЧОК ДЛЯ ДИСПЕНСЕРА И ВЫДАЧНОЕ УСТРОЙСТВО ДЛЯ ВЫДАЧИ ЖИДКИХ ЛЕКАРСТВЕННЫХ И/ИЛИ КОСМЕТИЧЕСКИХ СРЕДСТВ В ВИДЕ ЖИДКОСТИ (PROTECTIVE CAP FOR A DISPENSER AND A DISCHARGE DEVICE FOR DISCHARGING LIQUID MEDICINAL AND / OR COSMETIC MEANS AS A LIQUID)
Japan	5663595
Mexico	2016007853	TAPON PROTECTOR PARA UN SURTIDOR Y DISPOSITIVO DE DESCARGA PARA DESCARGAR LIQUIDOS FARMACEUTICOS Y/O COSMETICOS. (PROTECTIVE CAP FOR A DISPENSER, AND DISCHARGE DEVICE FOR DISCHARGING PHARMACEUTICAL AND/OR COSMETICAL LIQUIDS.)
World Intellectual Property Organization (WIPO)	2008035246
Japan	6731039

Supplementary Protection Certificates for cyclosporine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1809237	CA 2015 00030	Denmark		PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 20150319
2049079	PA2017003	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237	CR 2015 00030	Denmark		PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323
1809237	C01809237/01	Switzerland		PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016
2049079	PA2017003,C2049079	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237	C300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	122015000043	Germany		PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319