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Cyclosporine - Generic Drug Details

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

This ingredient has one patent family member in one country.

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

Summary for Generic Name: cyclosporine

Tradenames:5
Patents:6
Applicants:11
NDAs:18
Drug Master File Entries: see list17
Suppliers / Packaging: see list14
Therapeutic Class:Immunological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Clinical Trials for: cyclosporine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
GENGRAF
cyclosporine
CAPSULE;ORAL065003-002May 12, 2000RXNo
Allergan
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC050790-001Dec 23, 2002RXYes8,642,556Aug 27, 2024Y
Ivax Sub Teva Pharms
CYCLOSPORINE
cyclosporine
CAPSULE;ORAL065110-002Mar 29, 2005RXNo
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Expired Orange Book Patents for Generic Ingredient: cyclosporine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC050790-001Dec 23, 20025,474,979<disabled>
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 19955,985,321<disabled>
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 19955,985,321<disabled>
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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<disabled in preview>
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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)2005032577<disabled in preview>
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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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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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