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Last Updated: December 11, 2019

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AFINITOR DISPERZ Drug Profile

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Which patents cover Afinitor Disperz, and when can generic versions of Afinitor Disperz launch?

Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and twenty-six patent family members in forty-five countries.

The generic ingredient in AFINITOR DISPERZ 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.

US ANDA Litigation and Generic Entry Outlook for Afinitor Disperz

A generic version of AFINITOR DISPERZ was launched as everolimus by WEST-WARD PHARMS INT on December 11th, 2019.

Drug patent expirations by year for AFINITOR DISPERZ
Drug Prices for AFINITOR DISPERZ

See drug prices for AFINITOR DISPERZ

Recent Litigation for AFINITOR DISPERZ

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 AFINITOR DISPERZ litigation

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

See all AFINITOR DISPERZ litigation

Synonyms for AFINITOR DISPERZ
1245613-55-1
159351-69-6
351E696
40-O-(2-hydroxyethyl)-rapamycin
42-O-(2-Hydroxyethyl)rapamycin
9HW64Q8G6G
Afinitor
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
Zortress
Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
Tradename Dosage Ingredient NDA Submissiondate
AFINITOR DISPERZ TABLET, FOR SUSPENSION;ORAL everolimus 203985 2016-12-30

US Patents and Regulatory Information for AFINITOR DISPERZ

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 Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes   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
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 Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes 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
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 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 AFINITOR DISPERZ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012   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 AFINITOR DISPERZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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 300992 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/538/001,003,004,006-010 (C(2016)3286) 20160530
0663916 300154 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUSUM; NATIONAL REGISTRATION NO/DATE: RVG 30041 20040610; FIRST REGISTRATION: SE 18690 20030718
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
0663916 04C0012 France   Start Trial PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Mallinckrodt
McKinsey
AstraZeneca
Harvard Business School

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