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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 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.

Summary for AFINITOR

International Patents:	324
US Patents:	7
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	29
Clinical Trials:	154
Patent Applications:	6,417
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AFINITOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR
DailyMed Link:	AFINITOR at DailyMed

See drug prices for AFINITOR

Recent Clinical Trials for AFINITOR

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

Sponsor	Phase
University of Pennsylvania	Phase 1/Phase 2
Yonsei University	Phase 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 Name	Date
Point.360, a California Corporation	2017-10-10
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

Petitioner	Date
Hikma Pharmaceuticals PLC	2018-01-17
Breckenridge Pharmaceutial, Inc.	2017-06-12
West-Ward Pharmaceuticals International Limited	2017-03-13

See all AFINITOR litigation

Pharmacology for AFINITOR

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

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
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012		RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012		RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012		RX	Yes	Yes					Y
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012		RX	Yes	No					Y
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012		RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012		RX	Yes	No

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
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009

Paragraph IV (Patent) Challenges for AFINITOR

Drugname	Dosage	Strength	RLD	Date
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg
	Tablets	2.5 mg, 5 mg, and 7.5 mg
	Tablets	10 mg

International Patents for AFINITOR

Country	Patent Number	Estimated Expiration
Israel	202155
Norway	20012424
Germany	69322282
Hungary	228939
Norway	340553
Czech Republic	20032209
Japan	2009516671

Supplementary Protection Certificates for AFINITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269603	122015000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
0663916	2010/001	Ireland		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		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		PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
0663916	300154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NATIONAL REGISTRATION NO/DATE: RVG 30041 20040610; FIRST REGISTRATION: SE 18690 20030718
0663916	SZ 14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
0663916	C300154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718