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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Dow
Colorcon
Covington
QuintilesIMS
Cantor Fitzgerald
Chubb
Moodys
Citi

Generated: July 23, 2018

DrugPatentWatch Database Preview

RAPAMUNE Drug Profile

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When do Rapamune patents expire, and what generic alternatives are available?

Rapamune is a drug marketed by Pf Prism Cv and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in RAPAMUNE is sirolimus. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Drug patent expirations by year for RAPAMUNE
Medical Subject Heading (MeSH) Categories for RAPAMUNE
Synonyms for RAPAMUNE
(-)-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
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
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 RAPAMUNE

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 SOLUTION;ORAL 021083-001 Sep 15, 1999 RX Yes Yes ➤ 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
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 DISCN Yes No ➤ 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

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Expired US Patents for RAPAMUNE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ 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 TABLET;ORAL 021110-004 Jan 25, 2010 ➤ Sign Up ➤ Sign Up
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for RAPAMUNE
Drugname Dosage Strength RLD Date
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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Queensland Health
US Department of Justice
Merck
McKesson
US Army
Federal Trade Commission
Citi
Deloitte

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