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Generated: October 15, 2018

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Everolimus - Generic Drug Details

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What are the generic drug sources for everolimus and what is the scope of everolimus patent protection?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Novartis, and West-ward Pharms Int, and is included in four NDAs. There are ten patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for everolimus. One supplier is listed for this compound. There is one tentative approval for this compound.

Medical Subject Heading (MeSH) Categories for everolimus
Synonyms for everolimus
(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-((1R)-2-((1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo(
(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,35R)-1,18-dihydroxy-12-{(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.
(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-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-10,21-dimet
(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-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-9,10,12,13,14,21,22,23,24,25,26,2
1245613-55-1
159351-69-6
351E696
40-O-(2-hydroxyethyl)-rapamycin
42-O-(2-Hydroxyethyl)rapamycin
9HW64Q8G6G
Afinitor
Afinitor Disperz
AKOS015850977
AS-16971
AT-22180
BDBM50088378
BRD-K13514097-001-01-2
C53H83NO14
CAS-159351-69-6
Certican
CHEBI:68478
CHEMBL1908360
CS-0064
DB01590
dihydroxy-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxy-cyclohexyl]-1-methyl-ethyl]-dimethoxy-hexamethyl-[?]pentone
DSSTox_CID_20599
DSSTox_GSID_40599
DSSTox_RID_79508
DTXSID0040599
Everolimus - RAD001
Everolimus (INN)
Everolimus [USAN:INN:BAN]
Everolimus [USAN]
Everolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Everolimus, analytical standard
everolimusum
HSDB 8255
HY-10218
LS-143292
MolPort-003-847-342
NCGC00167512-01
NSC733504
NVP-RAD-001
PubChem20048
Q-101413
RAD
RAD 001
RAD-001
RAD-001C
RAD001
Rapamycin, 42-O-(2-hydroxyethyl)-
RL02051
SCHEMBL4378
SDZ-RAD
Tox21_112510
UNII-9HW64Q8G6G
V2036
Votubia
XIENCE V
Zortress
Tentative approvals for EVEROLIMUS
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up2.5MGTABLET;ORAL

US Patents and Regulatory Information for everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 ➤ Sign Up ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 ➤ Sign Up ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 ➤ Sign Up ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 ➤ Sign Up ➤ Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for everolimus

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004 00020 Denmark ➤ Sign Up PRODUCT NAME: EVEROLIMUS
0769 Netherlands ➤ Sign Up PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/538/001-008(C(2012)5347) 20120725
2015041 Lithuania ➤ Sign Up PRODUCT NAME: EVEROLIMUSUM; REGISTRATION NO/DATE: EU/1/09/538/001, EU/1/09/538/003, EU/1/09/538/004, EU/1/09/538/006-010 20120723
0849 Netherlands ➤ Sign Up PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/538/001-006 (C(2009)6251) 20090805
320 Luxembourg ➤ Sign Up PRODUCT NAME: TRAITEMENT DE TUMEURS SOLIDES RENALES AVEC UN DERIVE DE LA RAPAMYCINE
00154 Netherlands ➤ Sign Up PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
2015000094 Germany ➤ Sign Up PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Citi
Argus Health
Medtronic
Deloitte
UBS
Covington
Chinese Patent Office
Mallinckrodt

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