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Last Updated: February 19, 2020

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Everolimus - Generic Drug Details

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What are the generic sources for everolimus and what is the scope of freedom to operate?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Mylan, Novartis, Hikma, Par Pharm, and Teva Pharms Usa, and is included in seven 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 eighty-one patent family members in forty-eight countries.

There are twelve drug master file entries for everolimus. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Recent Clinical Trials for everolimus

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

SponsorPhase
CoImmunePhase 2
M.D. Anderson Cancer CenterEarly Phase 1
Massachusetts General HospitalPhase 4

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
2017-03-13

See all everolimus litigation

Generic filers with tentative approvals for EVEROLIMUS
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MGTABLET;ORAL
  Start Trial  Start Trial7.5MGTABLET;ORAL
  Start Trial  Start Trial5MGTABLET;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
Paragraph IV (Patent) Challenges for EVEROLIMUS
Tradename Dosage Ingredient NDA Submissiondate
AFINITOR DISPERZ TABLET, FOR SUSPENSION;ORAL everolimus 203985 2016-12-30
AFINITOR TABLET;ORAL everolimus 022334 2014-12-10
AFINITOR TABLET;ORAL everolimus 022334 2014-06-18
ZORTRESS TABLET;ORAL everolimus 021560 2013-09-30

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 AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130-001 Apr 19, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 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 everolimus

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 021560-002 Apr 20, 2010   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 021560-002 Apr 20, 2010   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012   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
2269604 2016C/075 Belgium   Start Trial DETAILS LICENCE: LICENCE, ENREGISTREMENT D'UNE NOUVELLE LICENCE
0663916 122004000033 Germany   Start Trial 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
3351246 PA2019521 Lithuania   Start Trial PRODUCT NAME: REPAMICINO DARINYS, SKIRTAS KIETO NAVIKO, SISIJUSIO SU NEREGULIUOJAMA ANGIOGENEZE, GYDYMUI; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269604 PA2016035 Lithuania   Start Trial PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
0663916 C300154 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
3143995 122019000051 Germany   Start Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526
2269604 CA 2016 00060 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Merck
Mallinckrodt
Baxter
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