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Last Updated: October 21, 2019

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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 patent protection?

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

Everolimus has three hundred and seventy-two patent family members in forty-eight countries.

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

Recent Clinical Trials for EVEROLIMUS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hospices Civils de LyonN/A
Nantes University HospitalPhase 3
Hull and East Yorkshire Hospitals NHS TrustPhase 2

See all EVEROLIMUS clinical trials

Recent Litigation for EVEROLIMUS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Point.360, a California Corporation2017-10-10
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2017-06-30
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2017-04-07

See all EVEROLIMUS litigation

PTAB Litigation
PetitionerDate
Hikma Pharmaceuticals PLC2018-01-17
Breckenridge Pharmaceutial, Inc.2017-06-12
West-Ward Pharmaceuticals International Limited2017-03-13

See all EVEROLIMUS litigation

Generic filers with tentative approvals for EVEROLIMUS
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for EVEROLIMUS
Synonyms for EVEROLIMUS
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 - 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
Zortress

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 Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 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 AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes   Start Trial   Start Trial   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 EVEROLIMUS

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

Supplementary Protection Certificates for EVEROLIMUS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663916 CA 2004 00020 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS
0663916 91104 Luxembourg   Start Trial 91104, EXPIRES: 20180718
2269604 2016C/075 Belgium   Start Trial PRODUCT NAME: EVEROLIMUS OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-006 20090805
2269603 92880 Luxembourg   Start Trial PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (AFINITOR); AUTHORISATION NUMBER AND DATE: EU/1/09/538/001,003,004 ET 006-010 - AFINITOR
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
0663916 SPC001/2010 Ireland   Start Trial SPC001/2010: 20101001, EXPIRES: 20180717
2269604 PA2016035 Lithuania   Start Trial PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
Merck
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McKesson
Colorcon

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.