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Last Updated: June 28, 2022

Sirolimus - Generic Drug Details


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What are the generic sources for sirolimus and what is the scope of freedom to operate?

Sirolimus is the generic ingredient in four branded drugs marketed by Nobelpharma, Aadi, Pf Prism Cv, Amneal, Apotex, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in twelve NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sirolimus has one hundred and twenty-eight patent family members in thirty countries.

There are twenty-one drug master file entries for sirolimus. Fifteen suppliers are listed for this compound.

Summary for sirolimus
Drug Prices for sirolimus

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Recent Clinical Trials for sirolimus

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

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

See all sirolimus clinical trials

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
Glenmark Pharms Ltd SIROLIMUS sirolimus TABLET;ORAL 208691-003 Oct 16, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys SIROLIMUS sirolimus TABLET;ORAL 201578-001 Oct 27, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
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 214753-002 Mar 12, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aadi FYARRO sirolimus POWDER;INTRAVENOUS 213312-001 Nov 22, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

Expired US Patents for sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

Supplementary Protection Certificates for sirolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0648494 01C0037 France See Plans and Pricing PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926
0763039 08C0018 France See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 SPC/GB08/025 United Kingdom See Plans and Pricing PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
0763039 PA2008009,C0763039 Lithuania See Plans and Pricing PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0648494 SPC/GB01/037 United Kingdom See Plans and Pricing PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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