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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Farmers Insurance
Johnson and Johnson
Julphar
McKinsey
Deloitte
Accenture
Dow
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Generated: April 24, 2018

DrugPatentWatch Database Preview

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 two hundred and eighty-eight patent family members in forty-five countries.

The generic ingredient in AFINITOR DISPERZ is everolimus. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.
Summary for AFINITOR DISPERZ
Drug patent expirations by year for AFINITOR DISPERZ
Medical Subject Heading (MeSH) Categories for AFINITOR DISPERZ
Synonyms for AFINITOR DISPERZ
(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-((1R)-2-((1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo(
(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,35R)-1,18-dihydroxy-12-{(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.
(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-((1R)-2-((1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-10,21-dimet
(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-3-{(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-9,10,12,13,14,21,22,23,24,25,26,2
1245613-55-1
159351-69-6
351E696
40-O-(2-hydroxyethyl)-rapamycin
42-O-(2-Hydroxyethyl)rapamycin
9HW64Q8G6G
Afinitor
AKOS015850977
AS-16971
AT-22180
BDBM50088378
BRD-K13514097-001-01-2
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
everolimusum
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
Zortress

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 203985-001 Aug 29, 2012 ➤ Sign Up ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 ➤ Sign Up ➤ Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe 2016-12-30

Non-Orange Book US Patents for AFINITOR DISPERZ

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,436,010 Treatment of solid tumors with rapamycin derivatives ➤ Sign Up
6,852,729 Macrolides ➤ Sign Up
7,572,804 Macrolides ➤ Sign Up
6,440,990 O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for AFINITOR DISPERZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000094 Germany ➤ Sign Up PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
C0012 France ➤ Sign Up PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
0769 Netherlands ➤ Sign Up 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
2004000033 Germany ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Argus Health
Chinese Patent Office
McKinsey
Cantor Fitzgerald
Dow
McKesson
Medtronic
Deloitte

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