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Last Updated: August 14, 2020

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SANDIMMUNE Drug Profile

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When do Sandimmune patents expire, and what generic alternatives are available?

Sandimmune is a drug marketed by Novartis and is included in three NDAs.

The generic ingredient in SANDIMMUNE is cyclosporine. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

US ANDA Litigation and Generic Entry Outlook for Sandimmune

A generic version of SANDIMMUNE was approved as cyclosporine by WEST-WARD PHARMS INT on October 29th, 1999.

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Drug patent expirations by year for SANDIMMUNE
Drug Prices for SANDIMMUNE

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Recent Clinical Trials for SANDIMMUNE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fred Hutchinson Cancer Research CenterPhase 1
Memorial Sloan Kettering Cancer CenterPhase 2
National Cancer Institute (NCI)Phase 2

See all SANDIMMUNE clinical trials

US Patents and Regulatory Information for SANDIMMUNE

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;ORAL 050625-001 Mar 2, 1990 AB2 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis SANDIMMUNE cyclosporine INJECTABLE;INJECTION 050573-001 Nov 14, 1983 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-003 Nov 23, 1992 BX RX Yes No   Start Trial   Start Trial   Start Trial
>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 SANDIMMUNE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-001 Mar 2, 1990   Start Trial   Start Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-002 Mar 2, 1990   Start Trial   Start Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-003 Nov 23, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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