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Last Updated: February 18, 2020

DrugPatentWatch Database Preview

ZORTRESS Drug Profile


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Which patents cover Zortress, and what generic alternatives are available?

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

This drug has fifty patent family members in twenty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Zortress

A generic version of ZORTRESS was approved as everolimus by HIKMA on April 12th, 2018.

  Start Trial

Drug patent expirations by year for ZORTRESS
Drug Prices for ZORTRESS

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Recent Clinical Trials for ZORTRESS

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SponsorPhase
M.D. Anderson Cancer CenterEarly Phase 1
Merck Sharp & Dohme Corp.Phase 3
Bristol-Myers SquibbPhase 1/Phase 2

See all ZORTRESS clinical trials

Recent Litigation for ZORTRESS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2017-06-30
Novartis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical Inc.2016-06-13
Novartis Pharmaceuticals Corporation v. Roxane Laboratories Inc.2015-06-10

See all ZORTRESS litigation

PTAB Litigation
PetitionerDate
2016-05-26
2016-05-17
2016-05-10

See all ZORTRESS litigation

Synonyms for ZORTRESS
1245613-55-1
159351-69-6
351E696
40-O-(2-hydroxyethyl)-rapamycin
42-O-(2-Hydroxyethyl)rapamycin
9HW64Q8G6G
Afinitor
Afinitor Disperz
AK323674
AKOS015850977
AS-16971
AT-22180
BDBM50088378
BRD-K13514097-001-01-2
BRD-K13514097-001-05-3
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
Everolimus; RAD001; SDZ-RAD
everolimusum
EX-A2057
GTPL5889
HKVAMNSJSFKALM-GKUWKFKPSA-N
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
ZINC169677008
Paragraph IV (Patent) Challenges for ZORTRESS
Tradename Dosage Ingredient NDA Submissiondate
ZORTRESS TABLET;ORAL everolimus 021560 2013-09-30

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   Start Trial   Start Trial Y   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-004 Aug 10, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZORTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZORTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3351246 301018 Netherlands   Start Trial 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
2269604 122016000094 Germany   Start Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
3143995 LUC00122 Luxembourg   Start Trial PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 20160530
3143995 2019C/528 Belgium   Start Trial PRODUCT NAME: EVEROLIMUS OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 (C(2016)3286) 20160530
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Merck
McKesson
AstraZeneca
Dow

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