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Last Updated: June 28, 2022

SIROLIMUS Drug Patent 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

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SponsorPhase
University of Missouri-ColumbiaPhase 1
Unity Health TorontoPhase 2
Center for International Blood and Marrow Transplant ResearchPhase 1

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Medical Subject Heading (MeSH) Categories for SIROLIMUS
Paragraph IV (Patent) Challenges for SIROLIMUS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RAPAMUNE Tablets sirolimus 0.5 mg 021110 1 2010-09-28
RAPAMUNE Tablets sirolimus 1 mg and 2 mg 021110 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 214753-003 Mar 12, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Torrent SIROLIMUS sirolimus SOLUTION;ORAL 215016-001 Dec 27, 2021 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for SIROLIMUS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Rapamune sirolimus EMEA/H/C/000273
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued.Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
Authorised no no no 2001-03-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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Baxter
Harvard Business School
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Express Scripts

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