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Sirolimus - Generic Drug Details

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What are the generic drug sources for sirolimus and what is the scope of sirolimus freedom to operate?

Sirolimus is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Dr Reddys Labs Ltd, and Zydus Pharms Usa Inc, and is included in four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for sirolimus. Seven suppliers are listed for this compound.

Summary for sirolimus

US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	21
Suppliers / Packagers:	7
Bulk Api Vendors:	48
Clinical Trials:	508
Patent Applications:	7,694
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for sirolimus
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sirolimus
DailyMed Link:	sirolimus at DailyMed

Pharmacology for sirolimus

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

Medical Subject Heading (MeSH) Categories for sirolimus

Anti-Bacterial Agents

Antibiotics, Antineoplastic

Antifungal Agents

Immunosuppressive Agents

Synonyms for sirolimus

(-)-Rapamycin

(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2S)-1-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.0(4,9)

(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-{(2S)-1-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]h

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34 aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hex adecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydro xy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy- 6

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-4,9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-heptadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-((1R)-2-((1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl)-1-methylethyl)-10,21-dimethoxy-6,8,1

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,1

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-3-{(1R)-2-[(1S,3R,4R)-4-hydroxy-3-(methyloxy)cyclohexyl]-1-methylethyl}-6,8,12,14,20,26-hexamethyl-10,21-bis(methyloxy)-9,10,12,13,14,21,22,23,24,25,26

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-3-{(2R)-1-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]propan-2-yl}-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34

1,18-Dihydroxy-12-[2-(4-hydroxy-3-methoxy-cyclohexyl)-1-methyl-ethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0*4,9*]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone (Rapamycin)

1179372-35-0

1189166-54-8

1233221-34-5

123R889

1353039-01-6

1fkb

1pbk

23,27-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine

53123-88-9

A-275

AC-722

AKOS015850976

AKOS015961618

Ambotz53123-88-9

Antibiotic AY 22989

AS-11687

AY 22989

AY-22989

AY22989

BC207597

BDBM36609

BDBM50064359

BIDD:PXR0165

BiomolKI2_000084

BRD-K84937637-001-04-0

BRD-K89626439-001-01-0

C51H79NO13

CAS-53123-88-9

CCG-100684

CCRIS 9024

CHEBI:9168

CS-0063

Cypher

DB00877

DE-109

DSSTox_CID_3582

DSSTox_GSID_23582

DSSTox_RID_77091

DTXSID5023582

EC 610-965-5

EX-A1044

FT-0082351

HMS2089A21

HMS3403F11

HSDB 7284

HY-10219

LCP-Siro

LS-143290

MFCD00867594

MolPort-003-959-433

MS-R001

NCGC00021305-05

NCGC00021305-06

NCGC00021305-07

NCGC00181146-01

NSC 226080

NSC226080

Perceiva

PubChem16645

Q-201659

R0097

RAP

RAPA

rapalimus

Rapammune

Rapamune

Rapamycin

Rapamycin (Sirolimus)

Rapamycin C-7, analog 4

Rapamycin from Streptomyces hygroscopicus, >=95% (HPLC), powder

Rapamycin from Streptomyces hygroscopicus, Vetec(TM) reagent grade, >=95%

Rapamycin, VETRANAL(TM), analytical standard

Rapamycin,Sirolimus,Rapamune

RL03960

S-7759

S1039

SCHEMBL3463

SILA 9268A

Sirolimus (RAPAMUNE)

Sirolimus [USAN:BAN:INN]

Sirolimus [USAN:INN:BAN]

Sirolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material

sirolimusum

Supralimus

SYN1185

Tox21_110870

Tox21_112750

UNII-W36ZG6FT64

UNM-0000358684

W36ZG6FT64

Wy 090217

WY-090217

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
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000	AB	RX	Yes	No					Y
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	AB	RX	Yes	No					Y
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002	AB	RX	Yes	Yes					Y
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000	AB	RX	Yes	No
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004		DISCN	Yes	No					Y
Zydus Pharms Usa Inc	SIROLIMUS	sirolimus	TABLET;ORAL	201676-003	Jan 8, 2014	AB	RX	No	No
Dr Reddys Labs Ltd	SIROLIMUS	sirolimus	TABLET;ORAL	201578-001	Oct 27, 2014	AB	RX	No	No

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
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002