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Generated: November 15, 2018

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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.

Medical Subject Heading (MeSH) Categories for sirolimus
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Dr Reddys Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 201578-001 Oct 27, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Dr Reddys Labs Ltd SIROLIMUS sirolimus TABLET;ORAL 201578-002 Oct 27, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Dow
Farmers Insurance
UBS
Queensland Health
US Department of Justice
Daiichi Sankyo
Healthtrust
Harvard Business School

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 verifification 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.