Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 17, 2019

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. One supplier is listed for this compound. Additional details are available on the everolimus profile page.

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
Bristol-Myers SquibbPhase 1/Phase 2
Indiana UniversityPhase 3
Dana-Farber Cancer InstitutePhase 1

See all ZORTRESS clinical trials

Recent Litigation for ZORTRESS

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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
Breckenridge Pharmaceutical, Inc.2016-05-26
Roxane Laboratories, Inc.2016-05-26
Par Pharmaceutical, Inc.2016-05-17

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

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
>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 021560-002 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 021560-002 Apr 20, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ZORTRESS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for ZORTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2269603 CA 2015 00058 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
0663916 CA 2004 00020 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS
2269604 93320 Luxembourg   Start Trial PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.