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Serving leading biopharmaceutical companies globally:

Novartis
Fuji
Healthtrust
Colorcon
Chinese Patent Office
Fish and Richardson
Johnson and Johnson
Daiichi Sankyo
Queensland Health
Boehringer Ingelheim

Generated: October 20, 2017

DrugPatentWatch Database Preview

Cyclosporine - Generic Drug Details

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

Cyclosporine
is the generic ingredient in six branded drugs marketed by Abbvie, West-ward Pharms Int, Ivax Sub Teva Pharms, Novartis, Sandoz, Wockhardt, Apotex, Mayne Pharma, Luitpold, Apotex Inc, and Allergan, and is included in eighteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has thirty-one patent family members in eleven countries.

There are seventeen drug master file entries for cyclosporine. Fifteen suppliers are listed for this compound.

Summary for Generic Name: cyclosporine

US Patents:10
Tradenames:6
Applicants:11
NDAs:18
Drug Master File Entries: see list17
Suppliers / Packagers: see list15
Bulk Api Vendors: see list105
Clinical Trials: see list848
Patent Applications: see list9,860
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cyclosporine at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
SANDIMMUNE
cyclosporine
CAPSULE;ORAL050625-003Nov 23, 1992BXRXYesNo► Subscribe► Subscribe► Subscribe
Allergan
RESTASIS MULTIDOSE
cyclosporine
EMULSION;OPHTHALMIC050790-002Oct 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sandoz
CYCLOSPORINE
cyclosporine
CAPSULE;ORAL065017-002Jan 13, 2000AB1RXNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
CYCLOSPORINE
cyclosporine
CAPSULE;ORAL065110-002Mar 29, 2005AB1RXNoNo► Subscribe► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995AB1RXYesYes► Subscribe► Subscribe► Subscribe
Allergan
RESTASIS MULTIDOSE
cyclosporine
EMULSION;OPHTHALMIC050790-002Oct 27, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Abbvie
GENGRAF
cyclosporine
CAPSULE;ORAL065003-001May 12, 2000AB1RXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
CYCLOSPORINE
cyclosporine
INJECTABLE;INJECTION065004-001Oct 29, 1999APRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 1995DISCNYesNo► Subscribe► Subscribe► Subscribe
Wockhardt
CYCLOSPORINE
cyclosporine
SOLUTION;ORAL065133-001Sep 17, 2004AB2RXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: cyclosporine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
SOLUTION;ORAL050716-001Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cyclosporine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,618,064Methods of providing therapeutic effects using cyclosporin components► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: cyclosporine

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2015091537► Subscribe
Japan5412302► Subscribe
Germany102009006431► Subscribe
South Korea20160097369► Subscribe
Germany102009006430► Subscribe
European Patent Office2210670► Subscribe
Canada2933062► Subscribe
World Intellectual Property Organization (WIPO)2015091539► Subscribe
Japan2017508673► Subscribe
European Patent Office3083432► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Fuji
Deloitte
Chubb
QuintilesIMS
Moodys
Medtronic
Healthtrust
Teva
Accenture

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 verifification 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.

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