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Last Updated: March 28, 2024

Sirolimus - Generic Drug Details


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What are the generic sources for sirolimus and what is the scope of patent protection?

Sirolimus is the generic ingredient in four branded drugs marketed by Nobelpharma, Aadi, Pf Prism Cv, Amneal, Apotex, MSN, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in thirteen NDAs. There are five 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 forty-nine patent family members in thirty-two countries.

There are twenty-one drug master file entries for sirolimus. Eighteen 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
Mirati Therapeutics Inc.Phase 1/Phase 2
Aadi Bioscience, Inc.Phase 1/Phase 2
The University of QueenslandPhase 3

See all sirolimus clinical trials

Pharmacology for sirolimus
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
Zydus Pharms SIROLIMUS sirolimus TABLET;ORAL 201676-003 Jan 8, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd SIROLIMUS sirolimus TABLET;ORAL 208691-002 Oct 16, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms SIROLIMUS sirolimus TABLET;ORAL 201676-001 Feb 15, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 214753-001 Mar 12, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys SIROLIMUS sirolimus TABLET;ORAL 201578-001 Oct 27, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aadi FYARRO sirolimus POWDER;INTRAVENOUS 213312-001 Nov 22, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alkem Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 214753-002 Mar 12, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021110-001 Aug 25, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ⤷  Try a Trial ⤷  Try a Trial
>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
Plusultra pharma GmbH Hyftor sirolimus EMEA/H/C/005896
Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.
Authorised no no yes 2023-05-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for sirolimus

Country Patent Number Title Estimated Expiration
Russian Federation 2011146132 КОМПОЗИЦИИ БЕЗ ПРИОНА НА ОСНОВЕ НАНОЧАСТИЦ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ ⤷  Try a Trial
Australia 2020375810 Pharmaceutical compositions of albumin and rapamycin ⤷  Try a Trial
Malaysia 175260 PRION FREE NANOPARTICLE COMPOSITIONS AND METHODS OF MAKING THEREOF ⤷  Try a Trial
Australia 2008223334 Nanoparticle comprising rapamycin and albumin as anticancer agent ⤷  Try a Trial
Slovenia 3313401 ⤷  Try a Trial
Portugal 2419732 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2021086946 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sirolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0648494 C00648494/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926
0763039 08C0018 France ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009,C0763039 Lithuania ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 C300348 Netherlands ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0648494 01C0037 France ⤷  Try a Trial PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926
0648494 SPC/GB01/037 United Kingdom ⤷  Try a Trial PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
0763039 SPC/GB08/025 United Kingdom ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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