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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, Watson Labs Inc, Luitpold, Watson Labs, 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:12
NDAs:18
Drug Master File Entries: see list17
Suppliers / Packaging: see list14
Therapeutic Class:Immunological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Clinical Trials for: cyclosporine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex
CYCLOSPORINE
cyclosporine
CAPSULE;ORAL065040-001May 9, 2002RXNo<disabled><disabled>
Luitpold
CYCLOSPORINE
cyclosporine
INJECTABLE;INJECTION065151-001Oct 7, 2003RXNo<disabled><disabled>
Novartis
SANDIMMUNE
cyclosporine
CAPSULE;ORAL050625-001Mar 2, 1990RXNo<disabled><disabled>
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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
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 19955,741,512<disabled>
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 19955,866,159<disabled>
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 19955,866,159<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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International Patent Family for Ingredient: cyclosporine

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005032577<disabled in preview>
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