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, 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
National Cord Blood Network	Phase 2
Fred Hutchinson Cancer Center	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
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Apotex	CYCLOSPORINE	cyclosporine	EMULSION;OPHTHALMIC	207606-001	Jan 12, 2023	AB	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
Sandoz	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065017-002	Jan 13, 2000	AB1	RX	No	No	⤷ 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
Ivax Sub Teva Pharms	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065110-003	Mar 29, 2005	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065044-002	Dec 20, 2000	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	050715-002	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	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
China	112823020	用于治疗干眼病的眼用组合物 (OPHTHALMIC COMPOSITION FOR TREATMENT OF DRY EYE DISEASE)	⤷ Sign Up
Germany	102009006431	Austragvorrichtung	⤷ Sign Up
China	101282714	Ophthalmic emulsions containing prostaglandins	⤷ Sign Up
China	102652022	Pharmaceutical composition for treatment of dry eye syndrome	⤷ Sign Up
South Korea	20180117661	국소형 시클로스포린 함유 제형 및 그의 용도	⤷ Sign Up
Israel	182897	OPHTHALMIC OIL-IN-WATER TYPE EMULSION WITH STABLE POSITIIVE ZETA POTENTIAL	⤷ Sign Up
Canada	3036306	COMPOSITIONS OPHTALMIQUES CONTENANT DE LA CYCLOSPORINE (OPHTHALMIC COMPOSITIONS COMPRISING CICLOSPORIN)	⤷ 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
1809237	CR 2015 00030	Denmark	⤷ Sign Up	PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323
1809237	122015000043	Germany	⤷ Sign Up	PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319
2049079	LUC00006	Luxembourg	⤷ Sign Up	PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
2049079	PA2017003,C2049079	Lithuania	⤷ Sign Up	PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
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
2049079	PA2017003	Lithuania	⤷ Sign Up	PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
>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.