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Last Updated: March 7, 2021

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Sirolimus - Generic Drug Details

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Summary for sirolimus
Drug Prices for sirolimus

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Recent Clinical Trials for sirolimus

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SponsorPhase
Chong Kun Dang PharmaceuticalPhase 4
University of PisaPhase 2
The Hospital for Sick ChildrenN/A

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Medical Subject Heading (MeSH) Categories for sirolimus
Paragraph IV (Patent) Challenges for SIROLIMUS
Tradename Dosage Ingredient NDA Submissiondate
RAPAMUNE TABLET;ORAL sirolimus 021110 2010-09-28
RAPAMUNE TABLET;ORAL sirolimus 021110 2010-08-25
RAPAMUNE TABLET;ORAL sirolimus 021110 2009-12-17

US Patents and Regulatory Information for sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 201578-002 Oct 27, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms SIROLIMUS sirolimus TABLET;ORAL 201676-003 Jan 8, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd SIROLIMUS sirolimus TABLET;ORAL 208691-003 Oct 16, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 DISCN 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 sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010   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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AstraZeneca
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McKesson

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