You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 1, 2024

Sirolimus - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug 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, 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

See drug prices for sirolimus

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
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
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms SIROLIMUS sirolimus TABLET;ORAL 201676-002 Feb 15, 2023 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 021110-003 Feb 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ⤷  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
Malaysia 175260 PRION FREE NANOPARTICLE COMPOSITIONS AND METHODS OF MAKING THEREOF ⤷  Try a Trial
Russian Federation 2559570 КОМПОЗИЦИИ БЕЗ ПРИОНА НА ОСНОВЕ НАНОЧАСТИЦ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (PRION-FREE COMPOSITIONS BASED ON NANOPARTICLES AND METHODS OF OBTAINING THEREOF) ⤷  Try a Trial
Japan 2018521057 類上皮細胞腫瘍を処置する方法 ⤷  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
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
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 PA2008009 Lithuania ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.