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 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:	5
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
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for SIROLIMUS
What excipients (inactive ingredients) are in SIROLIMUS?	SIROLIMUS excipients list
DailyMed Link:	SIROLIMUS at DailyMed

See drug prices for SIROLIMUS

Recent Clinical Trials for SIROLIMUS

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

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
Stanford University	Phase 1/Phase 2
Aadi Bioscience, Inc.	Phase 2

See all SIROLIMUS clinical trials

Pharmacology for SIROLIMUS

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for SIROLIMUS

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nobelpharma	HYFTOR	sirolimus	GEL;TOPICAL	213478-001	Mar 22, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	SIROLIMUS	sirolimus	SOLUTION;ORAL	211212-001	Oct 18, 2019	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	SOLUTION;ORAL	021083-001	Sep 15, 1999	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for SIROLIMUS

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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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2481409	Nanoparticule comportant du rapamycine et albumine en tant qu'agent anti-cancer (Nanoparticle comprising rapamycin and albumin as anticancer agent)	⤷ Sign Up
Eurasian Patent Organization	201890157	СПОСОБЫ ЛЕЧЕНИЯ ЭПИТЕЛИОИДНОКЛЕТОЧНЫХ ОПУХОЛЕЙ	⤷ Sign Up
Lithuania	2131821		⤷ Sign Up
Singapore	175239	PRION-FREE NANOPARTICLE COMPOSITIONS AND METHODS	⤷ Sign Up
Spain	2690175		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SIROLIMUS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0763039	PA2008009,C0763039	Lithuania	⤷ Sign Up	PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
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
0648494	SPC/GB01/037	United Kingdom	⤷ Sign Up	PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
0763039	C300348	Netherlands	⤷ Sign Up	PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0648494	C00648494/01	Switzerland	⤷ Sign Up	PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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