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

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Serving leading biopharmaceutical companies globally:

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Dow
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Last Updated: October 20, 2019

DrugPatentWatch Database Preview

AFINITOR Drug Profile

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When do Afinitor patents expire, and when can generic versions of Afinitor launch?

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are eight patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and twenty-four patent family members in forty-seven countries.

The generic ingredient in AFINITOR 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 AFINITOR
Drug Prices for AFINITOR

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Recent Clinical Trials for AFINITOR

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

SponsorPhase
University of PennsylvaniaPhase 1/Phase 2
Yonsei UniversityPhase 3
National Cancer Institute (NCI)Early Phase 1

See all AFINITOR clinical trials

Recent Litigation for AFINITOR

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 litigation

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

See all AFINITOR litigation

Synonyms for AFINITOR
1245613-55-1
159351-69-6
351E696
40-O-(2-hydroxyethyl)-rapamycin
42-O-(2-Hydroxyethyl)rapamycin
9HW64Q8G6G
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
Zortress

US Patents and Regulatory Information for AFINITOR

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for AFINITOR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe   Start Trial
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe   Start Trial
➤ Subscribe Tablets 10 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for AFINITOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2269603 122015000094 Germany   Start Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
0663916 2010/001 Ireland   Start Trial PRODUCT NAME: EVEROLIMUS; NAT REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803; FIRST REGISTRATION NO/DATE: 18960 018691 18962 18693 18694 18695. 20030718
0663916 SPC/GB10/003 United Kingdom   Start Trial PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803
0663916 04C0012 France   Start Trial PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
0663916 300154 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUSUM; NATIONAL REGISTRATION NO/DATE: RVG 30041 20040610; FIRST REGISTRATION: SE 18690 20030718
0663916 SZ 14/2004 Austria   Start Trial PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
0663916 C300154 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Colorcon
Moodys
McKinsey
Merck

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