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Generated: April 19, 2019

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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 sixteen 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
Medical Subject Heading (MeSH) Categories for AFINITOR
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 Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AFINITOR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 10 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for AFINITOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663916 122004000033 Germany ➤ Try a Free 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
2269604 2016C/075 Belgium ➤ Try a Free Trial PRODUCT NAME: EVEROLIMUS OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-006 20090805
0663916 300154 Netherlands ➤ Try a Free Trial PRODUCT NAME: EVEROLIMUSUM; NATIONAL REGISTRATION NO/DATE: RVG 30041 20040610; FIRST REGISTRATION: SE 18690 20030718
2269604 CA 2016 00060 Denmark ➤ Try a Free Trial PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805
2269603 122015000094 Germany ➤ Try a Free Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
0663916 SPC/GB10/003 United Kingdom ➤ Try a Free 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 C300154 Netherlands ➤ Try a Free 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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