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Last Updated: November 2, 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 six 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 fifty 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
International Patents:150
US Patents:6
Tradenames:4
Applicants:12
NDAs:13
Drug Master File Entries: 21
Finished Product Suppliers / Packagers: 18
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 687
Patent Applications: 4,252
Drug Prices: Drug price trends for SIROLIMUS
What excipients (inactive ingredients) are in SIROLIMUS?SIROLIMUS excipients list
DailyMed Link:SIROLIMUS at DailyMed
Drug Prices for SIROLIMUS

See drug prices for SIROLIMUS

Recent Clinical Trials for SIROLIMUS

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

SponsorPhase
Case Comprehensive Cancer CenterPhase 2
Stanford UniversityPhase 1/Phase 2
Aadi Bioscience, Inc.Phase 2

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
Msn SIROLIMUS sirolimus SOLUTION;ORAL 216728-001 Jan 19, 2023 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Torrent SIROLIMUS sirolimus SOLUTION;ORAL 215016-001 Dec 27, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 214753-003 Mar 12, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aadi FYARRO sirolimus POWDER;INTRAVENOUS 213312-001 Nov 22, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 SOLUTION;ORAL 021083-001 Sep 15, 1999 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ⤷  Sign Up ⤷  Sign Up
>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
World Intellectual Property Organization (WIPO) 2008109163 ⤷  Sign Up
European Patent Office 3417859 NANOPARTICULE COMPRENANT DE LA RAPAMYCINE ET DE L'ALBUMINE EN TANT QU'AGENT ANTI-CANCÉREUX (NANOPARTICLE COMPRISING RAPAMYCIN AND ALBUMIN AS ANTICANCER AGENT) ⤷  Sign Up
Portugal 3313401 ⤷  Sign Up
South Korea 102047634 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIROLIMUS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 18/2008 Austria ⤷  Sign Up PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0648494 C300055 Netherlands ⤷  Sign Up PRODUCT NAME: SIROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; NATL. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: CH CH/55243 20000926
0401747 25/2001 Austria ⤷  Sign Up PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
0763039 122008000023 Germany ⤷  Sign Up PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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