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Last Updated: June 12, 2021

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SIROLIMUS Drug Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Sirolimus

A generic version of SIROLIMUS was approved as sirolimus by ZYDUS PHARMS on January 8th, 2014.

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Drug patent expirations by year for SIROLIMUS
Drug Prices for SIROLIMUS

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Recent Clinical Trials for SIROLIMUS

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

SponsorPhase
The Perron InstitutePhase 3
University of Kansas Medical CenterPhase 3
ITB-Med LLCPhase 2

See all SIROLIMUS clinical trials

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
Amneal SIROLIMUS sirolimus SOLUTION;ORAL 211212-001 Oct 18, 2019 AA RX No No   Get Started Free   Get Started Free   Get Started Free
Dr Reddys Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 201578-001 Oct 27, 2014 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Alkem Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 214753-001 Mar 12, 2021 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Zydus Pharms SIROLIMUS sirolimus TABLET;ORAL 201676-003 Jan 8, 2014 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Dr Reddys Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 201578-002 Oct 27, 2014 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Apotex SIROLIMUS sirolimus SOLUTION;ORAL 211406-001 Oct 22, 2019 AA RX No No   Get Started Free   Get Started Free   Get Started Free
Novitium Pharma SIROLIMUS sirolimus SOLUTION;ORAL 211040-001 Jan 28, 2019 AA RX No No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Merck
McKinsey
AstraZeneca
Express Scripts

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