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Generated: November 20, 2018

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AFINITOR Drug Profile

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

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are eight patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.

Drug patent expirations by year for AFINITOR
Medical Subject Heading (MeSH) Categories for AFINITOR
Synonyms for AFINITOR
(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 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
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

US Patents and Regulatory Information for AFINITOR

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 ➤ Sign Up ➤ Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 ➤ 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 AFINITOR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 10 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for AFINITOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2016 Austria ➤ Sign Up PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
0663916/01 Switzerland ➤ Sign Up PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005
320 Luxembourg ➤ Sign Up PRODUCT NAME: TRAITEMENT DE TUMEURS SOLIDES RENALES AVEC UN DERIVE DE LA RAPAMYCINE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Dow
Healthtrust
Argus Health
Cipla
Queensland Health
Boehringer Ingelheim
Chinese Patent Office
Colorcon

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