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Generated: December 10, 2018

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ZORTRESS Drug Profile

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When do Zortress patents expire, and when can generic versions of Zortress launch?

Zortress is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-seven patent family members in twenty-eight countries.

The generic ingredient in ZORTRESS 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 ZORTRESS
Medical Subject Heading (MeSH) Categories for ZORTRESS
Synonyms for ZORTRESS
(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
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

US Patents and Regulatory Information for ZORTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 AB 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 ZORTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 ➤ Sign Up ➤ Sign Up
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 ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 ➤ Sign Up ➤ Sign Up
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 ➤ Sign Up ➤ Sign Up
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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ZORTRESS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for ZORTRESS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000094 Germany ➤ Sign Up PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
/2016 Austria ➤ Sign Up PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
2004000033 Germany ➤ Sign Up PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: 58387.00.00 58387.00.01 58387.01.00 58387.01.01 58387.02.00 58387.03.00 20040204 FIRST REGISTRATION: SCHWEDEN 18690 18691 18692 18693 18694 18695 20030718
C/GB10/003 United Kingdom ➤ Sign Up PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803
2016000094 Germany ➤ Sign Up PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
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
14/2004 Austria ➤ Sign Up PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Department of Justice
Fuji
Queensland Health
Cantor Fitzgerald
McKinsey
Deloitte
Healthtrust
Chinese Patent Office

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