Sirolimus - Generic Drug Details

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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, 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. Sixteen suppliers are listed for this compound.

Summary for sirolimus

International Patents:	128
US Patents:	4
Tradenames:	4
Applicants:	11
NDAs:	12
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	671
Patent Applications:	5,289
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
Peking University People's Hospital	Phase 1/Phase 2
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1/Phase 2
Beijing Tongren Hospital	Early Phase 1

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
Alkem Labs Ltd	SIROLIMUS	sirolimus	TABLET;ORAL	214753-001	Mar 12, 2021	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Alkem Labs Ltd	SIROLIMUS	sirolimus	TABLET;ORAL	214753-003	Mar 12, 2021	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing				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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	See Plans and Pricing	See Plans and Pricing
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	See Plans and Pricing	See Plans and Pricing
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	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

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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
>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
Australia	2008223334	Nanoparticle comprising rapamycin and albumin as anticancer agent	See Plans and Pricing
Poland	2481402		See Plans and Pricing
Australia	2016285720	Methods of treating epithelioid cell tumors	See Plans and Pricing
Mexico	2017016322	METODOS PARA TRATAR TUMORES DE CELULAS EPITELIOIDES. (METHODS OF TREATING EPITHELIOID CELL TUMORS.)	See Plans and Pricing
>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	18/2008	Austria	See Plans and Pricing	PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0648494	24/2001	Austria	See Plans and Pricing	PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
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
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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