Cyclosporine - Generic Drug Details

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What are the generic drug 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, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Harrow Eye, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-eight NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has two hundred and ninety-nine 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:	299
US Patents:	27
Tradenames:	9
Applicants:	17
NDAs:	28
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1,059
Patent Applications:	7,380
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
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2
Assiut University	Phase 1

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
Sandoz	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065017-001	Jan 13, 2000	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharm Assoc	CYCLOSPORINE	cyclosporine	SOLUTION;ORAL	065167-001	Jan 5, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	GENGRAF	cyclosporine	CAPSULE;ORAL	065003-002	May 12, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	GENGRAF	cyclosporine	CAPSULE;ORAL	065003-003	May 12, 2000	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y		Y	⤷ Sign Up
Novartis	SANDIMMUNE	cyclosporine	INJECTABLE;INJECTION	050573-001	Nov 14, 1983	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	216046-001	Aug 2, 2022	AB1	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

Expired US Patents for cyclosporine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
>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
Israel	181446	OPHTHALMIC EMULSIONS CONTAINING AN IMMUNOSUPPRESSIVE AGENT	⤷ Sign Up
China	101282714	Ophthalmic emulsions containing prostaglandins	⤷ Sign Up
South Korea	20070083573	OPHTHALMIC EMULSIONS CONTAINING AN IMMUNOSUPPRESSIVE AGENT	⤷ Sign Up
Finland	2887923		⤷ Sign Up
Mexico	2012006720	COMPOSICION FARMCEUTICA PARA EL TRATAMIENTO DE SINDROME DEL OJO SECO. (PHARMACEUTICAL COMPOSITION FOR TREATMENT OF DRY EYE SYNDROME.)	⤷ Sign Up
Canada	2586074	EMULSION OPHTALMIQUE DU TYPE HUILE DANS EAU A POTENTIEL ZETAPOSITIF STABLE (OPHTHALMIC OIL-IN-WATER TYPE EMULSION WITH STABLE POSITIVE ZETA POTENTIAL)	⤷ Sign Up
Spain	2586381		⤷ Sign Up
>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	⤷ Sign Up	PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237	C300741	Netherlands	⤷ Sign Up	PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	CR 2015 00030	Denmark	⤷ Sign Up	PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323
1809237	300741	Netherlands	⤷ Sign Up	PRODUCT NAME: CICLOSPORINE (EYE DROP EMULSION); REGISTRATION NO/DATE: EU/1/15/990 20150323
1809237	CA 2015 00030	Denmark	⤷ Sign Up	PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 20150319
1809237	122015000043	Germany	⤷ Sign Up	PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	C01809237/01	Switzerland	⤷ Sign Up	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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